ABSTRACT
Background: Depression is a common and disabling condition. Digital apps may augment or facilitate care, particularly in under-served populations. We tested the efficacy of juli, a digital self-management app for depression in a fully remote randomised controlled trial. Methods: A pragmatic randomised controlled trial that included participants aged > 18 who self-identified as having depression and scored > 5 on the Patient Health Questionnaire-8. Participants were randomly assigned (1:1) to receive juli for 8 weeks or a limited attention-placebo control app. Our primary outcome was the difference in Patient Health Questionnaire-8 scores at 8 weeks. Secondary outcomes were remission, minimal clinically important difference, worsening of depression, and health-related quality of life. Analyses were per-protocol (primary), and modified and full intention-to-treat (secondary). The trial was registered at ISRCTN (ISRCTN12329547). Results: Between May 2021 and January 2023, we randomised 908 participants. 662 completed the week 2 outcome assessment and were included in the modified intention-to-treat analysis, and 456 completed the week 8 outcome assessments (per-protocol). In the per-protocol analysis, the juli group had a greater reduction in Patient Health Questionnaire-8 score (10.78, standard deviation 6.26) than the control group (11.88, standard deviation 5.73) by week 8 (baseline adjusted ß-coefficient -0.94, 95% CI: -1.87 to -0.22, p = 0.045). Achieving remission and a minimal clinically important difference was more likely in the juli group at 8 weeks (adjusted odds ratios 2.22, 95% CI: 1.45-3.39, p < 0.001 and 1.56, 95% CI: 1.08-2.27, p = 0.018, respectively). There were no between-group differences in health-related quality of life or worsening of depression. Modified and full intention-to-treat analyses found similar results, but the primary outcome was non-significant. Conclusion: The use of juli for 8 weeks resulted in a small reduction in symptoms of depression compared with an attention-placebo control. The juli app is a digital self-management tool that could increase the accessibility of evidence-based depression treatments.
ABSTRACT
BACKGROUND: Asthma is one of the most common chronic conditions worldwide, with a substantial individual and health care burden. Digital apps hold promise as a highly accessible, low-cost method of enhancing self-management in asthma, which is critical to effective asthma control. OBJECTIVE: We conducted a fully remote randomized controlled trial (RCT) to assess the efficacy of juli, a commercially available smartphone self-management platform for asthma. METHODS: We conducted a pragmatic single-blind, RCT of juli for asthma management. Our study included participants aged 18 years and older who self-identified as having asthma and had an Asthma Control Test (ACT) score of 19 or lower (indicating uncontrolled asthma) at the beginning of the trial. Participants were randomized (1:1 ratio) to receive juli for 8 weeks or a limited attention-placebo control version of the app. The primary outcome measure was the difference in ACT scores after 8 weeks. Secondary outcomes included remission (ACT score greater than 19), minimal clinically important difference (an improvement of 3 or more points on the ACT), worsening of asthma, and health-related quality of life. The primary analysis included participants using the app for 8 weeks (per-protocol analysis), and the secondary analysis used a modified intention-to-treat (ITT) analysis. RESULTS: We randomized 411 participants between May 2021 and April 2023: a total of 152 (37%) participants engaged with the app for 8 weeks and were included in the per-protocol analysis, and 262 (63.7%) participants completed the week-2 outcome assessment and were included in the modified ITT analysis. Total attrition between baseline and week 8 was 259 (63%) individuals. In the per-protocol analysis, the intervention group had a higher mean ACT score (17.93, SD 4.72) than the control group (16.24, SD 5.78) by week 8 (baseline adjusted coefficient 1.91, 95% CI 0.31-3.51; P=.02). Participants using juli had greater odds of achieving or exceeding the minimal clinically important difference at 8 weeks (adjusted odds ratio 2.38, 95% CI 1.20-4.70; P=.01). There were no between group differences in the other secondary outcomes at 8 weeks. The results from the modified ITT analyses were similar. CONCLUSIONS: Users of juli had improved asthma symptom control over 8 weeks compared with users of a version of the app with limited functionality. These findings suggest that juli is an effective digital self-management platform that could augment existing care pathways for asthma. The retention of patients in RCTs and real-world use of digital health care apps is a major challenge. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) registry ISRCTN87679686; https://www.isrctn.com/ISRCTN87679686.
