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Newly diagnosed with inflammatory arthritis (NISMA)–development of a complex self-management intervention

BMC Health Services Research volume 23, Article number: 123 (2023) Cite this article

Abstract

Background

Patients newly diagnosed with inflammatory arthritis (IA) request regular consultations and support from health professionals to manage physiological, emotional, and social challenges. Evidence suggests that providing a tailored multi-component self-management program may benefit disease management. However, there is a lack of evidence of effective interventions with multiple components targeting the needs of this group. Therefore, the aim of this study was to develop a self-management intervention targeting newly diagnosed patients with IA, following the Medical Research Council (MRC) framework for developing complex interventions.

Methods

The development of the complex self-management intervention covered three steps. First, the evidence base was identified through literature reviews, in which we described a preliminary nurse-led intervention. Secondly, we chose Social Cognitive Theory as the underlying theory along with Acceptance and Commitment Theory to support our communication strategy. Thirdly, the preliminary intervention was discussed and further developed in workshops to ensure that the intervention was in accordance with patients’ needs and feasible in clinical practice.

Results

The developed intervention comprises a 9-month nurse-led intervention (four individual and two group sessions). A physiotherapist and an occupational therapist will attend the group sessions along with the nurse. All sessions should target IA-specific self-management with a particular focus on medical, role, and emotional management.

Conclusion

Through the workshops, we involved all levels of the organization to optimize the intervention, but also to create ownership and commitment, and to identify barriers and shortcomings of the preliminary intervention. As a result, from the existing evidence, we believe that we have identified effective mechanisms to increase self-management in people newly diagnosed with IA. Further, we believe that the involvement of various stakeholders has contributed significantly to developing a relevant and feasible intervention. The intervention is a nurse-led complex self-management intervention embedded in a multidisciplinary team (named NISMA). The intervention is currently being tested in a feasibility study.

Peer Review reports

Background

Inflammatory arthritis (IA) covers a group of diseases caused by an overactive immune system. The most common types of IA are Rheumatoid Arthritis (RA), axial Spondyloarthritis (axSpA), and Psoriatic Arthritis (PsA) [1]. These three types of IA affect more than 2% of the population worldwide, with considerable variation among ethnicities [2,3,4]. In Denmark, approximately 80,000 suffers from IA, with RA being the most common [5], and the socioeconomic costs of RA in Denmark are estimated at 24.000 US dollars per person per year [6].

IA can occur at any age and in both sexes. The cause of IA is multifactual and involves both genetic and lifestyle factors [4, 7]. IA manifests mainly with inflammation of the joints or the spine, characterized by pain and stiffness, but IA can also affect other connective tissues, e.g. eyes and skin, and the inflammation can result in irreversible damage of joints and lead to many comorbidities, e.g. cardiovascular disease and osteoporosis [4, 8, 9]. Therefore, a diagnosis of IA can have a substantial impact on an individual’s life and can affect several aspects of quality of life [10]. Fortunately, pharmacological treatment has improved significantly since the nineties, and especially, when treated early, remission is possible. However, management of IA can be complex due to its fluctuating nature, and even in remission, patients experience symptoms such as pain, joint stiffness, fatigue, sleep disturbances, and disability [4, 11, 12].

Studies have shown that especially when newly diagnosed, patients request regular consultations and available support—preferably within the first six months [13,14,15,16,17,18,19,20,21], as they are particularly fragile and insecure in their new situation. This indicates a particular need for guidance during the period right after diagnosis to enhance emotional, social, and physiological disease management [22]. Increased self-management can improve quality of life in patients with chronic illness [23,24,25,26,27,28,29]. Self-management can be defined as: the individual's ability to manage symptoms, treatments, lifestyle changes, and psychosocial and cultural consequences of illness [30]. According to the Corbin and Strauss and Lorig and Holman framework [31, 32], self-management programs must include medical management (such as taking medications and attending medical appointments), role management (such as adapting lifestyle and social relations), and emotional management (including processing emotions that arise from having a chronic illness). Furthermore, Lorig and Holman [31, 32] proposed that problem solving, decision making, resource utilization, forming a patient/health care provider partnership and action planning – also called the five core self-management strategies—should be integrated in self-management interventions. Moreover, self-management interventions should include various theoretical perspectives [31, 33,34,35,36].

However, when reviewing the substantial number of systematic reviews of arthritis-specific self-management interventions, we found that the effects of interventions are generally small [22, 24, 25, 37, 38] and that comparability of included studies is difficult due to heterogeneity in study design, as interventions are based on different theories, different program focus and modalities and uses different outcomes.

Despite the well-documented need for patient guidance during the period right after diagnosis [22], only a few studies of self-management interventions in chronic conditions have a special focus on the newly diagnosed, and to our knowledge, only one study has, targeted patients newly diagnosed with IA, and here the evaluation was simply based on qualitative data [39].

Therefore, there is a need for additional knowledge about the development of a self-management intervention specifically for this group of patients. New interventions must be systematically developed and evaluated based on qualitative and quantitative methods, in order to learn more about intervention acceptance and fidelity. Also, there is a need to learn more about the mechanisms of impact, efficacy vs. effect, and socioeconomic aspects of these multi-component interventions to make sustainable interventions in the future [40,41,42]. The Medical Research Council (MRC) provides a framework for developing and evaluating these complex interventions.

Aim

Therefore, the aim of this study was to develop a self-management intervention targeting newly diagnosed patients with IA, following the MRC Framework.

Methods

Design

This study is guided by the UK Medical Research Council’s (MRC) Framework for developing and evaluating complex interventions [40, 41]. This framework divides complex intervention research into four phases: 1) development or identification of the intervention, 2) feasibility, 3) evaluation (randomized controlled trial), and 4) implementation [41]. Here, we solely focus on the development phase.

The entire development and evaluation process should be understood as an iterative process, which is not necessarily sequential [41]; thus, we expect adjustments of the intervention based on the results of the subsequent feasibility test.

Setting

The intervention was developed at the Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark. We wished to develop an intervention suitable for this setting and á priori included the interdisciplinary staff employed in this clinic in the development phase. The purpose of this was to gain inputs and perspectives from the interdisciplinary staff and to create ownership, acceptance, and fidelity at all levels, in order to develop a realistic intervention relevant for daily clinical practice. We assume that the involvement of staff will smoothen the transition between feasibility, RCT, and finally, a possible implementation of the intervention in routine rheumatology care.

Patient involvement

Initially, three patients were involved in the design of the project, including the development of the preliminary intervention. Also, we involved a patient with RA as research partner in the project group in all project phases. Studies have shown that this helps maintain the patient perspective, the relevance of the project focus and structure, and the results [43].

Overview of the complex intervention development process

The stages in the development phase according to MRC are: 1) identifying the evidence base, 2) identifying the theoretical basis for the intervention, 3) modelling process and outcomes, and finally 4) a description of all components and outcomes of the intervention (Fig. 1) [40, 41]. In the following, each of these four phases is described in accordance with the checklist: Guidance for reporting intervention development studies in health research (GUIDED) [44].

Fig. 1
figure 1

Intervention development stage overview

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MRC stage 1. Identifying the evidence base—literature review

According to the MRC, the intervention can be developed either by developing a new intervention or adapting an existing intervention for a new context, based on research evidence and theory [40, 41]. Therefore, we conducted a literature review based on two research questions to support the development of the intervention and to assess if existing interventions were suitable for our patient’s needs and our context or if we needed to develop a new intervention (Fig. 2).

Fig. 2
figure 2

Results from review of the literature [45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62]

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The research team (LHL, TT, AdT, MAa, MLH, SDK, BAE) discussed key results from the review. First, we explored educational needs and supportive needs of the newly diagnosed. Next, we discussed the mix of intervention components regarding successful self-management interventions in patients with chronic conditions in general. Finally, we considered which results were appropriate to our setting.

The results of the literature review related to the frame and content based on the two research questions can be seen in Fig. 2. Further details of the literature reviews are presented in the supplementary material Tables A and B.

MRC stage 2. Identifying theory

Evidence shows that using theories in research will increase the quality and effectiveness of health interventions, making a theory-based intervention more likely to be effective than a purely empirical or pragmatic approach [63]. Therefore, we sought to identify a theoretical framework that could help us identify the essential elements in our self-management intervention [64].

During the literature reviews, we came across several theories that have been used in previous self-management interventions. We reviewed psychological theories of behavior change that incorporated the constructs of interest. Given the fact that self-management is built upon Social Cognitive Theory [58, 65], this was chosen as the underlying theory along with Acceptance and Commitment Therapy (ACT) [66] to support the enhancement of self-efficacy (Fig. 2).

Description of a preliminary self-management intervention

Based on stages 1 and 2, a preliminary intervention was described and discussed with two of the involved patients.

The preliminary intervention drafted by BAE consisted of a combination of individual consultations and group sessions embedded in a multidisciplinary team of nurses, physiotherapists (PT), and occupational therapists (OT). The sessions would focus on e.g., living with a chronic disease, knowledge about IA, unwrapping actual challenges and how to manage dominating symptoms, emotional distress, medical treatment as well as maintenance of a physical and socially active life. Details of the entire development phase are presented in Supplementary material in Tables A and B.

A description of the preliminary intervention was used as inspiration for the workshop discussions.

MRC stage 3. Modeling process and outcome

The possibility of reproducing a complex intervention is related to how explicitly the mechanisms of impact and its theory are specified. Thus, modeling a complex intervention can illustrate the underlying premises that are included in the intervention [67]. In our study, the modeling process covered two steps 1) Semi-structured workshops and analysis of results and 2) Modeling the intervention and outcomes [68]:

Step 1) Semi-structured workshops and analysis of results

For details about aim, methods, analysis, and results, see Table 1.

Table 1 The semi-structured workshops
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Step 2) Modeling the intervention and outcomes by using the logic modeling

In line with the MRC guidance, we developed a logic model to present the theoretical underpinning of the intervention [42]. See Fig. 3 for details.

Fig. 3
figure 3

The logic model

RNN: Registered Rheumatology Nurse; ACT: Acceptance and Commitment Therapy; HPR: Health Professional

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This provided an overview of the assumed mechanisms in the intervention and how the theory and assumptions underline the intervention. The logic model was refined throughout the intervention development process. The model covers eight core elements [70, 71]: Inputs (available necessary resources), Activities and Participants (activities in the intervention and who is delivering the intervention), Mechanisms of change (the expected behavior change mechanisms), Intermediate outcomes (the immediate benefits), Output (process evaluation measures), Outcomes (the direct benefits for the patients), and Impact (the long term endpoints).

The final model integrated results from the literature review, the chosen theory, workshops, and other feedback.

Selection of outcomes

Unfortunately, there is no validated single measure of self-management. Self-management is a complex construction with a person-centered approach, that addresses medical, social, and emotional issues, and historically the effect of self-management interventions have been measured with a great number of outcomes [38]. Systematic reviews [22, 24, 25, 37] have found that comparability of included studies was difficult, as they found over 70 variables, interventions were poorly described and data were collected with different measurement instruments. The results from the reviews showed a marginal effect of arthritis self-management interventions, perhaps because studies frequently assess outcomes that are not particularly targeted in these interventions. E.g., measuring pain, where the aim is not a reduction in pain, but a reduction in the perception of pain [22, 24, 25, 37]. Thus, it is relevant to discuss, what to measure, why the effects are sparse, and which outcomes these interventions address [22]. A recently published systematic self-management outcome review [38] identified all patient-reported outcomes (PROs) and validated questionnaires used to measure self-management. Together with responses from the workshops and the literature, we chose relevant outcomes (Table 2). Subsequently, we identified relevant validated questionnaires to measure our selected outcomes. These questionnaires have previously been validated in a similar population and can be used in a clinical setting to investigate the effect in randomized controlled trials.

Table 2 Outcomes and measurements
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We carefully considered the order of the demographic questions and the questionnaires, and our collection of validated questionnaires was face-validated by five patients through cognitive interviews [83] with rheumatoid arthritis or psoriatic arthritis (23–77 years/ three men and two women). The respondents were selected to ensure equal distribution across age and gender. Adaption of the order of the demographic questions and the questionnaires was made accordingly.

MRC stage 4. The final intervention

Through the two-step modeling process, the final intervention NISMA (Newly diagnosed with Inflammatory arthritis – a Self-MAnagement intervention) was developed. The research team agreed on of mix of individual and group sessions. The same rheumatology-trained nurse should facilitate all the four individual sessions. To demonstrate interdisciplinary agreement, the group sessions consisted of a nurse, an occupational therapist (OT), and a physiotherapist (PT), with the nurse being the facilitator.

The workshops uncovered a need for a smaller time range between the sessions at the beginning of the intervention, and we decided to allocate the sessions as illustrated in Table 3.

Table 3 The NISMA intervention
Full size table

Manual, HPR competence development and training

The research team developed a comprehensive manual, describing each session and the overall intervention strategy and framework. Our patient research partner and experts in rheumatology and self-management commented on the content to secure content validity. In addition, we conducted cognitive interviews with the HPRs to determine the face validity of the manual and we conducted a two-day competence program in October 2021 to train HPRs in delivering the intervention to secure fidelity and acceptance.

Discussion

In this paper, we have described the development of a complex self-management intervention aimed at increasing self-management in patients newly diagnosed with IA. Throughout the development process, we followed the MRC framework for the development of complex interventions [41]. This approach has made the development phase dynamic, systematic, feasible, and transparent.

According to applicable EULAR (European Alliance of Associations for Rheumatology) recommendations [84], self-management should be included in daily rheumatology care to support patients to become active partners in their treatment. EULAR highlights the importance of including patient education and key self-management interventions such as problem-solving and action planning as well as a CBT approach in rheumatology practice. All these elements have been included in our intervention. From the literature reviews, we identified what we believe to be active ingredients in effective self-management interventions including theoretical underpinning and rationale for behavior change, as illustrated in our logic model. The intervention was adjusted to our setting and our population through workshops. We believe that the identified components are essential to increase self-management in newly diagnosed patients with IA. However, the optimum mix of intervention components in the self-management of newly diagnosed patients with IA remains uncertain, and it is still unknown whether a subtle change in the components, mode, or intensity of our self-management intervention can optimize outcomes. In addition, little is known about how to distinguish attenders from non-attenders in self-management interventions for chronic diseases [29].

Several patient-related factors in these types of interventions influence the effects of self-management interventions. These include demographic factors such as socioeconomic status and culture, clinical factors such as comorbidities and complexity of the treatment regimen, and system factors such as quality of relationships and communication with HPRs [85]. Large variation in effect size between patients has been demonstrated in systematic reviews [29, 49]. So not only do we need to identify ‘what works best?’, but we also need to identify ‘what works best for whom?’ and to adjust the content in the intervention to the individual level. We hope that we with our individually tailored and person-centered approach will be able to accommodate this need. However, this also leaves us with a black box, as the person-centered approach makes it difficult to pinpoint exactly how the intervention was delivered and what the content was. Therefore, a thorough process evaluation will be conducted in our feasibility study, to evaluate both context, content, and individual factors [42].

Through the workshops, we involved all levels of the organization, both to optimize the intervention, but also to create ownership and commitment and to identify barriers and shortcomings of the preliminary intervention. As a result of the workshop, we identified potential problem areas to which we will pay particular attention in the feasibility study. These areas include capacity in the clinic, time allocated for conversation, continuity in and duration of the intervention, and stratification in group sessions. We have involved patients and HPRs in the identification of relevant outcomes and the identification of HPR's competence upgrading needs.

This project can only be successfully conducted if the HPRs understand the principles of self-management and the operational theories are used. To create fidelity and acceptance of the intervention, we have prepared a comprehensive manual, a competence development program, and continuous supervision for the HPRs. In addition, intervention acceptance and fidelity will be explored in the feasibility study from both the patients’ and the HPR’s perspectives through observations and interviews. Such strategy is in accordance with the MRC framework which highlights that process evaluation is essential to designing and testing complex interventions [41, 42].

With this intervention, we aim to strengthen rheumatological nursing and multidisciplinary collaboration. In addition, we hope that supporting patients successfully self-manage their arthritis, can improve their quality of life and prevent unsustainable health care costs in the future.

Strengths and limitations

Our systematic approach based on the MRC framework [40, 41] has secured a transparent and rigorous process. The NISMA intervention was based on current evidence and further adapted in close collaboration with patients, HPRs, rheumatologists, the research team, and the clinic’s management team.

Because of the Covid pandemic, only two patients attended the workshops, which is a limitation, as more patients could have given a broader perspective. However, the workshop data, systematic review, and collaboration with patient partners ensured that the intervention design included a solid patient focus.

Conclusion

NISMA—A nurse-led complex self-management intervention embedded in a multidisciplinary team, has been developed and described based on MRC’s framework for the development of complex interventions. The intervention is targeted at increasing self-management in the newly diagnosed and consists of several components to accommodate the complex issues the newly diagnosed may have. The intervention is currently being tested in a feasibility study.

Availability of data and materials

The datasets supporting the conclusions of this article are included within the article and in the supplementary material.

References

  1. What Is Arthritis? | Arthritis Foundation. [cited 2022 Sep 12]. Available from: https://www.arthritis.org/health-wellness/about-arthritis/understanding-arthritis/what-is-arthritis.

  2. Gladman D, Antoni C, Mease P, Clegg D, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(Suppl 2):ii14-7.

    Google Scholar 

  3. Bohn R, Cooney M, Deodhar A, Curtis JR, Golembesky A. Incidence and prevalence of axial spondyloarthritis: methodologic challenges and gaps in the literature. Clin Exp Rheumatol. 2018;36(2):263–74.

    Google Scholar 

  4. Smolen JS, Aletaha D, Barton A, Burmester GR, Emery P, Firestein GS, et al. Rheumatoid arthritis. Nat Rev Dis Primer. 2018;08(4):18001.

    Article  Google Scholar 

  5. The Danish Rheumatism Association. [cited 2020 Dec 1]. Available from: https://www.gigtforeningen.dk/for-forskere/the-danish-rheumatism-association/.

  6. Ny Hvidbog: National Handlingsplan for Leddegigt | Ergoterapeutforeningen. [cited 2022 Nov 3]. Available from: https://www.etf.dk/aktuelt/nyheder/ny-hvidbog-national-handlingsplan-leddegigt-0.

  7. Veale DJ, Fearon U. The pathogenesis of psoriatic arthritis. Lancet Lond Engl. 2018;391(10136):2273–84.

    Article  CAS  Google Scholar 

  8. Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet Lond Engl. 2017;390(10089):73–84.

    Article  Google Scholar 

  9. Taurog JD, Chhabra A, Colbert RA. Ankylosing Spondylitis and Axial Spondyloarthritis. N Engl J Med. 2016;374(26):2563–74.

    Article  Google Scholar 

  10. Kojima M, Kojima T, Ishiguro N, Oguchi T, Oba M, Tsuchiya H, et al. Psychosocial factors, disease status, and quality of life in patients with rheumatoid arthritis. J Psychosom Res. 2009;67(5):425–31.

    Article  Google Scholar 

  11. Ishida M, Kuroiwa Y, Yoshida E, Sato M, Krupa D, Henry N, et al. Residual symptoms and disease burden among patients with rheumatoid arthritis in remission or low disease activity: a systematic literature review. Mod Rheumatol. 2018;28(5):789–99.

    Article  Google Scholar 

  12. Holdren M, Schieir O, Bartlett SJ, Bessette L, Boire G, Hazlewood G, et al. Improvements in Fatigue Lag Behind Disease Remission in Early Rheumatoid Arthritis: Results From the Canadian Early Arthritis Cohort. Arthritis Rheumatol. 2021;73(1):53–60.

    Article  CAS  Google Scholar 

  13. Madsen M, Jensen KV, Esbensen BA. Men’s experiences of living with ankylosing spondylitis: a qualitative study. Musculoskeletal Care. 2015;13(1):31–41.

    Article  Google Scholar 

  14. Kristiansen TM, Primdahl J, Antoft R, Hørslev-Petersen K. Everyday Life with Rheumatoid Arthritis and Implications for Patient Education and Clinical Practice: A Focus Group Study: Everyday Life with Rheumatoid Arthritis. Musculoskeletal Care. 2012;10(1):29–38.

    Article  Google Scholar 

  15. Zangi HA, Ndosi M, Adams J, Andersen L, Bode C, Boström C, et al. EULAR recommendations for patient education for people with inflammatory arthritis. Ann Rheum Dis. 2015;74(6):954–62.

    Article  CAS  Google Scholar 

  16. White A, McKee M, Richardson N, Visser R d, Madsen SA, Sousa BC d, et al. Europe’s men need their own health strategy. BMJ. 2011;343(n2):d7397–d7397.

    Article  Google Scholar 

  17. Clarke LH, Bennett E. ‘You learn to live with all the things that are wrong with you’: gender and the experience of multiple chronic conditions in later life. Ageing Soc. 2013;33(2):342–60.

    Article  Google Scholar 

  18. Sumpton D, Kelly A, Tunnicliffe DJ, Craig JC, Hassett G, Chessman D, et al. Patients’ Perspectives and Experience of Psoriasis and Psoriatic Arthritis: A Systematic Review and Thematic Synthesis of Qualitative Studies. Arthritis Care Res. 2020;72(5):711–22.

    Article  Google Scholar 

  19. Hammer NM, Flurey CA, Jensen KV, Andersen L, Esbensen BA. Preferences for Self-Management and Support Services in Patients With Inflammatory Joint Disease: A Danish Nationwide Cross-Sectional Study. Arthritis Care Res. 2021;73(10):1479–89.

    Article  Google Scholar 

  20. Dures E, Bowen C, Brooke M, Lord J, Tillett W, McHugh N, et al. Diagnosis and initial management in psoriatic arthritis: a qualitative study with patients. Rheumatol Adv Pract. 2019;3(2):rkz022.

    Article  Google Scholar 

  21. Hehir M, Carr M, Davis B, Radford S, Robertson L, Tipler S, et al. Nursing support at the onset of rheumatoid arthritis: Time and space for emotions, practicalities and self-management. Musculoskeletal Care. 2008;6(2):124–34.

    Article  CAS  Google Scholar 

  22. Nolte S, Elsworth GR, Newman S, Osborne RH. Measurement issues in the evaluation of chronic disease self-management programs. Qual Life Res Int J Qual Life Asp Treat Care Rehabil. 2013;22(7):1655–64.

    Article  Google Scholar 

  23. Lorig K, Ritter PL, Plant K. A disease-specific self-help program compared with a generalized chronic disease self-help program for arthritis patients. Arthritis Rheum. 2005;53(6):950–7.

    Article  Google Scholar 

  24. Nolte S, Osborne RH. A systematic review of outcomes of chronic disease self-management interventions. Qual Life Res Int J Qual Life Asp Treat Care Rehabil. 2013;22(7):1805–16.

    Article  Google Scholar 

  25. Warsi A, LaValley MP, Wang PS, Avorn J, Solomon DH. Arthritis self-management education programs: a meta-analysis of the effect on pain and disability. Arthritis Rheum. 2003;48(8):2207–13.

    Article  Google Scholar 

  26. Nuñez DE, Keller C, Ananian CD. A review of the efficacy of the self-management model on health outcomes in community-residing older adults with arthritis. Worldviews Evid Based Nurs. 2009;6(3):130–48.

    Article  Google Scholar 

  27. Iversen MD, Hammond A, Betteridge N. Self-management of rheumatic diseases: state of the art and future perspectives. Ann Rheum Dis. 2010;69(6):955–63.

    Article  Google Scholar 

  28. Brady, Murphy, Beauchesne, Bhalakia. Sorting through the Evidence of the Arthritis Self-Management Program and the Chronic Disease Self-Management Program: Executive Summary of the ASMP/CDSMP Meta-Analyses. Atlanta: Centers for Disease Control and Prevention (US) (2011). Available from: http://www.cdc.gov/arthritis/docs/ASMP-executive-summary.pdf. Centers for Disease Control and Prevention.

  29. Jonkman NH, Schuurmans MJ, Groenwold RHH, Hoes AW, Trappenburg JCA. Identifying components of self-management interventions that improve health-related quality of life in chronically ill patients: Systematic review and meta-regression analysis. Patient Educ Couns. 2016;99(7):1087–98.

    Article  Google Scholar 

  30. Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self-management approaches for people with chronic conditions: a review. Patient Educ Couns. 2002;48(2):177–87.

    Article  Google Scholar 

  31. Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med Publ Soc Behav Med. 2003;26(1):1–7.

    Article  Google Scholar 

  32. Corbin JM, Strauss A. Unending work and care: Managing chronic illness at home. San Francisco: Jossey-Bass; 1988. p. 358 (xviii, (Unending work and care: Managing chronic illness at home)).

    Google Scholar 

  33. Holman HR, Lorig K. Perceived self-efficacy in self-management of chronic disease. In: Self-efficacy: Thought control of action. Washington: Hemisphere Publishing Corp; 1992. p. 305–23.

    Google Scholar 

  34. Prochaska JO, DiClemente CC. The transtheoretical approach. In: Prochaska JO, editor. Handbook of psychotherapy integration. 2nd ed. New York: Oxford University Press; 2005. p. 147–71 (Oxford series in clinical psychology).

    Chapter  Google Scholar 

  35. Dures E, Hewlett S. Cognitive-behavioural approaches to self-management in rheumatic disease. Nat Rev Rheumatol. 2012;17(8):553–9.

    Article  Google Scholar 

  36. Novak M, Costantini L, Schneider S, Beanlands H. Approaches to Self-Management in Chronic Illness. Semin Dial. 2013;26(2):188–94.

    Article  Google Scholar 

  37. Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH. Self-management education programs in chronic disease: a systematic review and methodological critique of the literature. Arch Intern Med. 2004;164(15):1641–9.

    Article  Google Scholar 

  38. Hansen CW, Esbensen BA, de Thurah A, Christensen R, de Wit M, Cromhout PF. Outcome measures in rheumatology applied in self-management interventions targeting people with inflammatory Arthritis A systematic review of outcome domains and measurement instruments. Semin Arthritis Rheum. 2022;1(54):151995.

    Article  Google Scholar 

  39. Codd Y, Coe Á, Kane D, Mullan RH, Stapleton T. A multidisciplinary-led early arthritis service to manage client-identified participation restrictions in early inflammatory arthritis: A qualitative study of service user and staff perspectives. Musculoskeletal Care. 2022;7.

  40. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013;50(5):587–92.

    Article  Google Scholar 

  41. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;30(374):n2061.

    Article  Google Scholar 

  42. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;19(350):h1258.

    Article  Google Scholar 

  43. de Wit MPT, Berlo SE, Aanerud GJ, Aletaha D, Bijlsma JW, Croucher L, et al. European League Against Rheumatism recommendations for the inclusion of patient representatives in scientific projects. Ann Rheum Dis. 2011;70(5):722–6.

    Article  Google Scholar 

  44. Duncan E, O’Cathain A, Rousseau N, Croot L, Sworn K, Turner KM, et al. Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study. BMJ Open. 2020;10(4):e033516.

    Article  Google Scholar 

  45. Solomon DH, Warsi A, Brown-Stevenson T, Farrell M, Gauthier S, Mikels D, et al. Does self-management education benefit all populations with arthritis? A randomized controlled trial in a primary care physician network. J Rheumatol. 2002;29(2):362–8.

    Google Scholar 

  46. Bode C, Taal E, Emons PAA, Galetzka M, Rasker JJ, Van de Laar MAFJ. Limited results of group self-management education for rheumatoid arthritis patients and their partners: explanations from the patient perspective. Clin Rheumatol. 2008;27(12):1523–8.

    Article  Google Scholar 

  47. Combe B, Landewe R, Daien CI, Hua C, Aletaha D, Álvaro-Gracia JM, et al. 2016 update of the EULAR recommendations for the management of early arthritis. Ann Rheum Dis. 2017;76(6):948–59.

    Article  Google Scholar 

  48. Newman S, Steed L, Mulligan K. Self-management interventions for chronic illness. Lancet Lond Engl. 2004;364(9444):1523–37.

    Article  Google Scholar 

  49. Hardman R, Begg S, Spelten E. What impact do chronic disease self-management support interventions have on health inequity gaps related to socioeconomic status: a systematic review. BMC Health Serv Res. 2020;20(1):150.

    Article  Google Scholar 

  50. Ellard D r, Barlow J h, Paskins Z, Stapley J, Wild A, Rowe I f. Piloting education days for patients with early rheumatoid arthritis and their partners: A multidisciplinary approach. Musculoskeletal Care. 2009;7(1):17–30.

    Article  CAS  Google Scholar 

  51. Radford S, Carr M, Hehir M, Davis B, Robertson L, Cockshott Z, et al. ‘It’s quite hard to grasp the enormity of it’: Perceived needs of people upon diagnosis of rheumatoid arthritis. Musculoskeletal Care. 2008;6(3):155–67.

    Article  CAS  Google Scholar 

  52. Landgren E, Bremander A, Lindqvist E, Nylander M, Van der Elst K, Larsson I. “Mastering a New Life Situation” – Patients’ Preferences of Treatment Outcomes in Early Rheumatoid Arthritis – A Longitudinal Qualitative Study. Patient Prefer Adherence. 2020;13(14):1421–33.

    Article  Google Scholar 

  53. Stack RJ, Sahni M, Mallen CD, Raza K. Symptom complexes at the earliest phases of rheumatoid arthritis: a synthesis of the qualitative literature. Arthritis Care Res. 2013;65(12):1916–26.

    Article  Google Scholar 

  54. Withall J, Haase AM, Walsh NE, Young A, Cramp F. Physical activity engagement in early rheumatoid arthritis: a qualitative study to inform intervention development. Physiotherapy. 2016;102(3):264–71.

    Article  Google Scholar 

  55. Sverker A, Östlund G, Thyberg M, Thyberg I, Valtersson E, Björk M. Dilemmas of participation in everyday life in early rheumatoid arthritis: a qualitative interview study (The Swedish TIRA Project). Disabil Rehabil. 2015;37(14):1251–9.

    Article  Google Scholar 

  56. Prip A, Møller KA, Nielsen DL, Jarden M, Olsen MH, Danielsen AK. The Patient-Healthcare Professional Relationship and Communication in the Oncology Outpatient Setting. Cancer Nurs. 2018;41(5):E11–22.

    Article  Google Scholar 

  57. Sabater-Galindo M, Fernandez-Llimos F, Sabater-Hernández D, Martínez-Martínez F, Benrimoj SI. Healthcare professional-patient relationships: Systematic review of theoretical models from a community pharmacy perspective. Patient Educ Couns. 2016;99(3):339–47.

    Article  Google Scholar 

  58. Bandura A. Social cognitive theory: an agentic perspective. Annu Rev Psychol. 2001;52:1–26.

    Article  CAS  Google Scholar 

  59. Gonzalez VM, Goeppinger J, Lorig K. Four psychosocial theories and their application to patient education and clinical practice. Arthritis Rheum. 1990;3(3):132–43.

    Article  CAS  Google Scholar 

  60. Sharpe L, Sensky T, Timberlake N, Ryan B, Allard S. Long-term efficacy of a cognitive behavioural treatment from a randomized controlled trial for patients recently diagnosed with rheumatoid arthritis. Rheumatol Oxf Engl. 2003;42(3):435–41.

    Article  CAS  Google Scholar 

  61. Pears S, Sutton S. Effectiveness of Acceptance and Commitment Therapy (ACT) interventions for promoting physical activity: a systematic review and meta-analysis. Health Psychol Rev. 2021;15(1):159–84.

    Article  Google Scholar 

  62. Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006;44(1):1–25.

    Article  Google Scholar 

  63. Jaarsma T, Westland H, Vellone E, Freedland KE, Schröder C, Trappenburg JCA, et al. Status of Theory Use in Self-Care Research. Int J Environ Res Public Health. 2020;17(24):E9480.

    Article  Google Scholar 

  64. O’Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, et al. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019;9(8):e029954.

    Article  Google Scholar 

  65. Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977;84(2):191–215.

    Article  CAS  Google Scholar 

  66. Newman S, Steed L, Mulligan K, Newman S, Steed L, Mulligan K. Self-management interventions for chronic illness. Lancet. 2004;364:1523–37 (Lancet 364, 1523-1532).

    Article  Google Scholar 

  67. Richards DA, Hallberg I, editors. Complex interventions in health: an overview of research methods. London; New York: Routledge, Taylor & Francis Group; 2015. p. 381.

  68. Bjerre E, Hansen ABG. Komplekse interventioner i medicinsk forskning. Ugeskr Laeger. 2018;19:V06170479.

    Google Scholar 

  69. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.

    Article  Google Scholar 

  70. Anderson LM, Petticrew M, Rehfuess E, Armstrong R, Ueffing E, Baker P, et al. Using logic models to capture complexity in systematic reviews: Logic Models in Systematic Reviews. Res Synth Methods. 2011;2(1):33–42.

    Article  Google Scholar 

  71. Mills T, Lawton R, Sheard L. Advancing complexity science in healthcare research: the logic of logic models. BMC Med Res Methodol. 2019;19(1):55.

    Article  Google Scholar 

  72. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27(1):117–26.

    Article  Google Scholar 

  73. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983;17(1):45–56.

    Article  Google Scholar 

  74. Primdahl J, Esbensen BA, Pedersen AK, Bech B, de Thurah A. Validation of the Danish versions of the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaires (BRAFs). Scand J Rheumatol. 2021;19:1–9.

    Google Scholar 

  75. Maindal HT, Kayser L, Norgaard O, Bo A, Elsworth GR, Osborne RH. Cultural adaptation and validation of the Health Literacy Questionnaire (HLQ): robust nine-dimension Danish language confirmatory factor model. Springerplus. 2016;5(1):1232.

    Article  Google Scholar 

  76. Sørensen J, Davidsen M, Gudex C, Pedersen K, Brønnum-Hansen H. Danish EQ-5D population norms. Scand J Public Health. 2009;1(37):467–74.

    Article  Google Scholar 

  77. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.

    Article  CAS  Google Scholar 

  78. Devins G. Using the Illness Intrusiveness Ratings Scale to understand health-related quality of life in chronic disease. J Psychosom Res. 2010;1(68):591–602.

    Article  Google Scholar 

  79. Hvidberg L, Virgilsen L, Pedersen A, Aro A, Vedsted P. Measurement properties of the Danish version of the Illness Perception Questionnaire-Revised for patients with colorectal cancer symptoms. J Health Psychol. 2013;1:19.

    Google Scholar 

  80. Brady TJ. Measures of self-efficacy: Arthritis Self-Efficacy Scale (ASES), Arthritis Self-Efficacy Scale-8 Item (ASES-8), Children’s Arthritis Self-Efficacy Scale (CASE), Chronic Disease Self-Efficacy Scale (CDSES), Parent’s Arthritis Self-Efficacy Scale (PASE), and Rheumatoid Arthritis Self-Efficacy Scale (RASE). Arthritis Care Res. 2011;63(S11):S473–85.

    Article  Google Scholar 

  81. Areskoug-Josefsson K, Ekdahl C, Jakobsson U, Gard G. Swedish version of the multi dimensional health assessment questionnaire - Translation and psychometric evaluation. BMC Musculoskelet Disord. 2013;4(14):178.

    Article  Google Scholar 

  82. Danmark i Bevægelse. SDU. [cited 2021 Apr 28]. Available from: https://www.sdu.dk/da/forskning/danmark_i_bevaegelse.

  83. Willis GB, Artino AR. What Do Our Respondents Think We’re Asking? Using Cognitive Interviewing to Improve Medical Education Surveys. J Grad Med Educ. 2013;5(3):353–6.

    Article  Google Scholar 

  84. Nikiphorou E, Santos EJF, Marques A, Böhm P, Bijlsma JW, Daien CI, et al. 2021 EULAR recommendations for the implementation of self-management strategies in patients with inflammatory arthritis. Ann Rheum Dis. 2021;80(10):1278–85.

    Article  Google Scholar 

  85. Schulman-Green D, Jaser S, Martin F, Alonzo A, Grey M, McCorkle R, et al. Processes of Self-Management in Chronic Illness. J Nurs Scholarsh Off Publ Sigma Theta Tau Int Honor Soc Nurs Sigma Theta Tau. 2012;44(2):136–44.

    Google Scholar 

  86. Betteridge N. Self-management of rheumatic diseases: State of the art and future perspectives. [cited 2021 May 26]; Available from: https://core.ac.uk/reader/1664954?utm_source=linkout.

  87. Parenti G, Tomaino SCM, Cipolletta S. The experience of living with rheumatoid arthritis: A qualitative metasynthesis. J Clin Nurs. 2020;29(21–22):3922–36.

    Article  Google Scholar 

  88. Patientuddannelse - En Medicinsk Teknologivurdering. [cited 2022 Dec 30]. Available from: https://www.sst.dk/da/udgivelser/2009/patientuddannelse---en-medicinsk-teknologivurdering.

  89. Lorig K, Feigenbaum P, Regan C, Ung E, Chastain RL, Holman HR. A comparison of lay-taught and professional-taught arthritis self-management courses. J Rheumatol. 1986;13(4):763–7.

    CAS  Google Scholar 

  90. Lorig KR, Ritter PL, Laurent DD, Plant K. The internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Arthritis Rheum. 2008;59(7):1009–17.

    Article  Google Scholar 

  91. Oehler C, Görges F, Böttger D, Hug J, Koburger N, Kohls E, et al. Efficacy of an internet-based self-management intervention for depression or dysthymia – a study protocol of an RCT using an active control condition. BMC Psychiatry. 2019;19(1):90.

    Article  Google Scholar 

  92. Andersson G, Topooco N, Havik O, Nordgreen T. Internet-supported versus face-to-face cognitive behavior therapy for depression. Expert Rev Neurother. 2016;16(1):55–60.

    Article  CAS  Google Scholar 

  93. Rchaidia L, Dierckx de Casterlé B, De Blaeser L, Gastmans C. Cancer patients’ perceptions of the good nurse: a literature review. Nurs Ethics. 2009;16(5):528–42.

    Article  Google Scholar 

  94. Vries AMMD, de Roten Y, Meystre C, Passchier J, Despland JN, Stiefel F. Clinician characteristics, communication, and patient outcome in oncology: a systematic review. Psychooncology. 2014;23(4):375–81.

    Article  Google Scholar 

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Acknowledgements

We would like to give special thanks to the patients who participated in both the initial phases of the intervention development and in the workshops.

We would also like to thank the cooperative outpatient clinic for their involvement in the development. The authors would like to acknowledge the advisory board members.

Funding

This project is funded by the Novo Nordisk Foundation Case number: NNF19OC0056658 and the Danish Rheumatism Association. Case number: R212-A7721.

Neither awarding body has had any role in the design of the study.

Author information

Authors and Affiliations

  1. Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Valdemar Hansens Vej 17, 2600, Glostrup, Denmark

    L. H. Lindgren, T. Thomsen, M. L. Hetland & B. A. Esbensen

  2. Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

    T. Thomsen & M. Aadahl

  3. Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark

    A. de Thurah

  4. Department of Clinical Medicine, Aarhus University, Aarhus, Denmark

    A. de Thurah

  5. Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

    M. Aadahl, M. L. Hetland & B. A. Esbensen

  6. Patient Research Partner, Copenhagen, Denmark

    S. D. Kristensen

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  1. L. H. Lindgren
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  7. B. A. Esbensen
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Contributions

All authors contributed to the design of the study and the development of the intervention. LHL led the development phase and conducted the literature review. BAE led interviews, workshops, and brainstorming meetings was a facilitator in the workshop, and followed the development phase closely. All authors (LHL, TT, AT, MA, MLH, SDK, BAE) contributed substantially to the data analysis and in the design and modeling of the intervention. LHL and BAE contributed significantly to the preparation of the manuscript. LHL drafted the manuscript together with BAE and TT. All authors read, critically revised, and approved the final version of the manuscript. All authors are accountable for all aspects of the work.

Corresponding author

Correspondence to L. H. Lindgren.

Ethics declarations

Ethics approval and consent to participate

Ethical approval from the Regional Scientific Ethical Committee was accepted and registered (H-21027110). The project was accepted and registered by the Danish Data Protection Agency (journal- number.: P-2021–38). All data were treated confidentially and following EU legislation and data security regulations and legislation (GDPR). The principles of the Declaration of Helsinki were followed. Participants from the workshop received oral and written information before signing consent forms.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Supplementary Information

Additional file 1: T

able A. Intervention development – frame [86,87,88,89,90,91,92,93,94].

Additional file 2: Table B.

Intervention development – content.

Additional file 3: Table C.

Workshop Interview guide.

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Lindgren, L.H., Thomsen, T., de Thurah, A. et al. Newly diagnosed with inflammatory arthritis (NISMA)–development of a complex self-management intervention. BMC Health Serv Res 23, 123 (2023). https://doi.org/10.1186/s12913-022-09007-w

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BMC Health Services Research

ISSN: 1472-6963

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