This will be a longitudinal cohort study using qualitative and quantitative methods.
The study will be conducted in GP surgeries, community diabetes clinics and hospital based diabetes clinics within two inner city London boroughs: There are approximately 80 GP surgeries, two services providing a range of community diabetes clinics and three hospitals running diabetes clinics within these two boroughs. Our aim is to make HeLP-Diabetes available to up to 30 GP surgeries and all diabetes clinics. Within these boroughs there are 16,223 people on GP registers with a recorded diagnosis of diabetes . Since T2DM accounts for 90% of all diabetes cases, there are up to 14,601 potential users of HeLP-Diabetes within these two boroughs.
The use of HeLP-Diabetes will be offered to GP surgeries and diabetes clinics free of charge for the duration of the study (30 months). HeLP-Diabetes will be made available to batches of GP surgeries and clinics (approx. 2 or 3 at a time). This will allow learning and experience gained from the implementation at each batch of sites to be transferred to subsequent ones. Once organisations have agreed to use HeLP-Diabetes they will be asked to opt-in to the research evaluation study. Organisations who opt-out of the research evaluation will still be free to use HeLP-Diabetes without participation in the research.
Staff working in services that agree to use HeLP-Diabetes will be asked to recommend its use to all suitable patients with T2DM and refer them to a training appointment with a researcher or a member of the clinical team. Suitable times to recommend the use of HeLP-Diabetes may include at annual diabetes reviews and when a patient is newly diagnosed. Staff will also be encouraged to maintain engagement with HeLP-Diabetes by encouraging patients to use it at appropriate times during routine consultations.
During training appointments patients will be registered on the HeLP-Diabetes site and shown how to use it. Each appointment will be tailored to the specific needs of the patient and will focus on an aspect of diabetes self-management important to the patient. At the end of the training appointment patients will be invited to take part in the research study evaluating the implementation of HeLP-Diabetes. Patients who agree to take part in the evaluation study will be asked to sign a consent form after reading the participant information sheet and having the opportunity to ask any questions. Patients who opt-out of the research evaluation will still be free to use HeLP-Diabetes without participation in the research.
Ethical approval for this study was gained from the NRES Committee East Midlands-Leicester ref: 13/EM/0033.
Recruitment will happen at both organisational and patient level.
Both organisations and patients will be recruited firstly to use HeLP-Diabetes and secondly to take part in the research evaluation of the implementation.
Strategies being explored to recruit organisations to use HeLP-Diabetes include engagement of the Clinical Commissioning Groups (CCG), direct contacts with hospital and community based clinics and the assistance of the North Central London Research Consortium (NoCLOR) to recruit GP surgeries.
Staff in participating services who opt in to the research evaluation will be invited to take part in research activities on an opportunistic basis throughout the study period.
Once a GP surgery or diabetes clinic has agreed to use HeLP-Diabetes, recruitment to use HeLP-Diabetes at the patient level will begin. Health professionals in participating GP surgeries and clinics will be asked to recommend the use of HeLP-Diabetes to all patients with T2DM who meet the inclusion criteria and to refer them to a training appointment. At the end of training appointments, eligible patients will be asked to participate in the research study evaluating the implementation of HeLP-Diabetes.
A range of staff from GP surgeries and diabetes clinics including consultants, salaried doctors, junior hospital doctors, general practice partners, general practice managers, practice nurses, community nurses, hospital diabetes nurses and reception staff will be recruited to participate in the research evaluation study. The aim is to represent a range of perspectives of the staff who contribute to the care of patients with T2DM on the implementation of HeLP-Diabetes.
To use HeLP-Diabetes and participate in the evaluation study, patients must be 18 or above, registered at participating GP surgeries, community diabetes clinics or hospital based diabetes clinics and have a diagnosis of T2DM. Patients will be excluded from the research evaluation if they are unable to provide informed consent, e.g. due to psychosis, dementia or severe learning disabilities, are terminally ill (life expectancy less than 12 months), unable to use a computer due to physical or mental impairment or possess English language skills insufficient to use the intervention.
An implementation plan has been devised by the research team which will be offered to all services. This plan includes the following steps; an initial meeting at the GPsurgery or clinic to explain the new HeLP-Diabetes service, a demonstration of HeLP-Diabetes, training for staff who will be using HeLP-Diabetes top-up training and support as necessary, training patients to use HeLP-Diabetes, follow up contact with patients, continued monitoring and feedback to staff, and the provision of training materials to staff and patients. Each GP surgery and diabetes clinic will be invited to work with researchers to tailor the implementation plan to the individual setting.
The researcher will spend time with staff to implement HeLP-Diabetes and to provide support and facilitate patient training appointments. Formal feedback from interviews with staff and patients and informal feedback such as lessons learned from training staff and patients will be used by the researcher to develop and refine the implementation procedures. The iterative design will allow the implementation plan to be tested out on a small scale, the researcher to learn from the experience and modifications to be made to plan before testing it on a another small number of services. This method will allow for difficulties and challenges to be explored and addressed, which may otherwise be missed by widespread implementation. Through the process of modifying the implementation plan based on feedback from patients and staff and by allowing the implementation plan to be tailored to individual sites, we hope to increase buy-in and ownership of HeLP-Diabetes by staff and reduce barriers to successful implementation.
The study objectives will be addressed in the following ways.
To describe the uptake and use of HeLP-Diabetes by NHS services and patients.
The number of GP surgeries and diabetes clinics HeLP-Diabetes is offered to, and the numbers who take it up will be recorded. To describe the types of services that take up HeLP-Diabetes we will collect data including: the number of patients registered at the surgery or who attend the clinic (overall numbers and those with T2DM), socio demographics of the patient population and the number of staff. For GP surgeries we will also collect: Quality and Outcomes Framework (QOF) achievement and whether it is a training or non-training practice.
The number of patients who register on HeLP-Diabetes will be recorded and patient registration data will be used to describe the characteristics of patients who sign up. This data will include; year of birth, gender, ethnicity, the surgery or clinics they attend, duration of diabetes, existence of complications, how diabetes is currently managed; what help the patient would like with self-management, smoking status, internet access (home/public) and use of computer (basic/intermediate/advanced).
Data on HeLP-Diabetes use will be recorded automatically by the website software and Google Analytics and will include number of logins, length of time patients use HeLP-Diabetes per visit, pages that are visited and those that are not, and the tools, assessments, educational modules that are used and how often.
To identify factors which inhibit or facilitate implementation.
Semi-structured interviews will be conducted with key informants, both patients and health professionals and will be focussed on exploring the barriers and facilitators to implementation. The researcher will also keep detailed notes on the implementation process and document any challenges and successes.
To identify the resources needed for effective implementation.
A proforma will be used to collect quantitative data on the resources spent on implementing HeLP-Diabetes, which are predicted to be largely made up of staff and researcher time. Semi-structured interviews will be conducted with key informants, both patients and health professionals, to investigate the resources needed for effective implementation.
To explore the effects of HeLP-Diabetes on self-reported patient outcomes.
Patient participants will be asked to complete two self-report measures. The first will be the Problem Areas in Diabetes (PAID) scale  which is a health related quality of life and emotional distress measure. It is comprised of 20 items focusing on areas that cause difficulty for people living with diabetes including; social situations, food, friends and family, diabetes treatment, emotions, relationships with healthcare professionals and social support. The second measure will be the Diabetes Management Self-Efficacy Scale (DMSES-UK)  which measures the individual’s efficacy expectations for engaging in 20 diabetes self-management activities, for example, taking daily exercise and keeping to a healthy eating plan when away from home. A sample size of 100 patients will detect a 3.5 point difference in the mean PAID score from baseline and a 9 point difference in the mean DMSES score from baseline. These calculations are based on 90% power (α = 0.05).
Additional self-report measures may be introduced to new cohorts of patients in order to test developing hypotheses generated by interviews with patients and staff. For example, if a theme emerges from the interviews suggesting that using HeLP-Diabetes may increase patients’ levels of physical activity, we may administer a physical activity self-report measure to a new cohort of patients at baseline, 3 months and 12 months to quantitatively explore this. Power and sample size will be calculated for each new measure prior to it being administered.
After consenting to take part in the evaluation research study, patient participants will be allocated a unique study ID number and complete baseline measures. Participants will be asked to provide their email address, postal address and contact number for data collection purposes. They will be sent a link in an email to a web-based case report form which will host the data collection measures. The data entered into this form will be anonymous and only linked to the patient by the unique ID number. Participants will be asked to complete socio-demographic information at baseline and self-report measures at baseline, 3 months and 12 months. Socio-demographic information will be collected to describe the sample, and to compare intervention use and self-report measure data.
Both patient and health professional participants will be asked to take part in semi-structured interviews. Each participant may be interviewed several times throughout the course of the study. We will sample until saturation is reached. In order to capture a breadth of experiences interviews will be conducted with patients from a range of ethnic backgrounds, ages, socio-demographic statuses, length of time with diabetes, treatment types, and associated complications, as well as a range of experience with computers and the internet. Similarly, to capture a range of staff experiences, we will seek to interview consultants, salaried doctors, junior hospital doctors, general practice partners, general practice managers, practice nurses, community nurses, hospital diabetes nurses and reception staff from GP surgeries and diabetes clinics. It is likely that there will be different levels of engagement with HeLP-Diabetes and with the evaluation research study between different members of staff and between different services and sites. Therefore, not all interviews will be face to face; initial interviews and follow-up encounters with some participants may be short, highly focused telephone interviews. These will minimise the demand on participants, and is likely to be much more cost effective. However, more in-depth, semi structured interviews will be conducted with participants wherever possible. Participants may be sampled purposefully at times to ensure that we have captured a range of experiences and opinions.
Data on intervention use will be recorded automatically by the intervention software and Google Analytics and will be downloaded into a spread sheet. Data on the type of GP surgeries and diabetes clinics that take up HeLP-Diabetes will be collected from Population Manager Data, Public Health Observatories  data and a data collection form to be completed by the Practice Manager or Clinic Lead at each site. The time spent by individuals involved in the implementation of HeLP-Diabetes will be recorded on a proforma.
The proportion of GP surgeries and clinics offered HeLP-Diabetes who adopt it, the number of patients who register on HeLP-Diabetes, the socio-demographic characteristics of the patients who take part in the evaluation study and the characteristics of the clinics and GP surgeries that adopt HeLP-Diabetes will be described using descriptive statistics. SPSS statistical software  will be used for coding and analysing these data. Descriptive statistics will also be used to explain how patients make use of HeLP-Diabetes including counts of pages accessed, number of logins, the times of use, the duration of use and the patterns of use by different users. This data will be recorded automatically by the website software. The time and other resources expended on implementing HeLP-Diabetes will be recorded on a proforma and these will be collated on a spread sheet and data described descriptively.
The cost of health professional input from the GP surgeries and clinics will be based on national average rates using Personal Social Services Research Unit estimates. Estimates of the additional time required from the general practice and clinic staff where HeLP-Diabetes is implemented will be calculated from responses in the qualitative interviews. Resources required in training individual patients to use HeLP-Diabetes will be estimated.
Participant scores on the PAID and DSMSE-UK scales will be compared statistically at the different time points using a repeated measures analysis of variance test using time as the independent variable. If a statistically significant effect is found post-hoc tests will be used to explore this further. Follow up PAID and DSMSE-UK scores will be adjusted for initial scores and other baseline covariates including age, gender, and duration of diabetes. Group effects including gender and age will be assessed using mixed-between within subjects analysis of variance.
With respondents’ consent, all semi-structured interviews will be audio-recorded, transcribed (and edited to ensure anonymity of respondent) and data will be subjected to formal analysis. Patient and staff interviews will be analysed inductively to identify themes and categories, a process of constant comparison will be used to establish analytical categories. Atlas. ti  data collation and management software will be used to aid data management and analysis.