Table 3 Overview of positive healthcare effects, indications, study designs, observation durations, sample sizes, IG, CG
DiGA | Positive care effect | Medical benefit | Patient-relevant improvement of structure and processes | Study design | Observation duration and survey times | Sample size | IG | CG | Location of study | Time period of studyb |
|---|---|---|---|---|---|---|---|---|---|---|
Deprexis | medical benefit | improvement in the state of health | n.a | RCT | 3 months t1 = 3 months t2 = 6 months follow-up | DiGA + UC UC + waiting group | ||||
Study 1 [17] | n = 163 IG = 78 CG = 85 | Hamburg, Lübeck, Bern | 02/2013–05/2014 | |||||||
Study 2 [18] | n = 1013 IG = 509 CG = 504 | Berlin, Bielefeld, Hamburg, Lübeck | 07/2012–02/2017 | |||||||
Elevida [19] | medical benefit | improvement in the state of health | n.a | RCT | 12 weeks t1 = 12 weeks t2 = 24 weeks follow-up | n = 275 IG = 139 CG = 136 | DiGA + UC | UC + waiting group | Hamburg | 07/2014–05/2016 |
Hello Better | medical benefit | improvement in the state of health | n.a | RCT | 8 weeks t1 = 8 weeks t2 = 6 months follow-up 1 t3 = 12 months follow-up 2 | n = 254 IG = 128 CG = 126 | DiGA + UC | UC + waiting group + online program for knowledge transfer | Lüneburg | 03/2013–01/2015 |
Hello Better | medical benefit | improvement in the state of health | n.a | RCT | 8 weeks t1 = 8 weeks t2 = 3 months follow-up 1 t3 = 6 months follow-up 2 | n = 92 IG = 45 CG = 47 | DiGA + UC | UC + waiting group | Lüneburg | 08/2013–05/2015 |
Hello Better | medical benefit | improvement in the state of health | n.a | RCT | 7 weeks t1 = 7 weeks t2 = 6 months follow-up 1 t3 = 12 months follow-up 2, only IG | n = 264 IG = 132 CG = 132 | DiGA + UC | UC + waiting group | Lüneburg | 03/2013–11/2014 |
Hello Better | medical benefit | improvement in the state of health | n.a | RCT | 12 weeks t1 = 12 weeks t2 = 6 months follow-up | n = 200 IG = 100 CG = 100 | DiGA + UC | UC + waiting group | Erlangen | 04/2016–9/2018 |
Kalmeda [28] | medical benefit | improvement in the state of health | n.a | RCT | 9 months (IG) 12 months (CG) t1 = 3 months t2 = 9 months (IG) t3 = 12 months (CG) | n = 187 IG = 94 CG = 93 | DiGA | waiting group + general information about tinnitus | Duisburg | 08/2020–04/2022 |
Selfapy Depression [29] | medical benefit | improvement in the state of health | n.a | RCT | 12 weeks t1 = 6 weeks t2 = 12 weeks t3 = 24 weeks follow-up | n = 401 IG1 = 151 IG2 = 150 CG = 100 | IG1: DiGA with psychological support (proof not provided) IG2: DiGA without any support | waiting group + weekly standardized mindfulness exercises via email | Berlin | 08/2019-n.r |
Somnio [30] | medical benefit | improvement in the state of health | n.a | RCT | 6 weeks t1 = 6 weeks t2 = 12 months follow-up | n = 56 IG = 29 CG = 27 | DiGA | waiting group | Zurich | 01/2016–10/2016 |
Velibra [31] | medical benefit + patient-relevant improvement of structure and processes | improvement in the state of health | reduction of therapy-related efforts and strains for patients and their relatives | RCT | 9 weeks t1 = 9 weeks t2 = 6 months follow-up | n = 139 IG = 70 CG = 69 | DiGA + UC | UC + waiting group | Bern | 05/2014–05/2016 |
Vivira [32] | medical benefit | improvement in the state of health | n.a | RCT | 12 weeks t1 = 2 weeks t2 = 6 weeks t3 = 12 weeks | n = 215 | DiGA | UC (physiotherapy) | Tübingen | 11/2020–03/2021 |
pre-post studya | 12 weeks | hip = 256 knee = 402 | ||||||||
Vorvida [33] | medical benefit + patient-relevant improvement of structure and processes | improvement in the state of health | patient autonomy | RCT | 6 months t1 = 3 months t2 = 6 months | n = 608 IG = 306 CG = 302 | DiGA + UC | UC + waiting group | Hamburg | 03/2015-ongoing |
Zanadio [34] | medical benefit | improvement in the state of health | n.a | RCT | 9 months t1 = 3 months t2 = 6 months t3 = 9 months t4 = 12 months follow-up | n = 149 | DiGA | UC | online in Germany | 02/2021-ongoing |