Currently accepted at: JMIR mHealth and uHealth
Date Submitted: Apr 29, 2025
Date Accepted: Mar 19, 2026
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/76724
The final accepted version (not copyedited yet) is in this tab.
Support Strategies to Enhance Adherence in a Prescription Digital Therapeutic for Erectile Dysfunction: Retrospective Quasi-Experimental Cohort Study.
ABSTRACT
Background:
Adherence in digital therapies remains a critical challenge. Despite increasing adoption of certified digital health applications (DiGAs), real-world data on strategies to improve long-term engagement is limited. Simple, scalable interventions such as SMS reminders and telephone follow-ups may offer potential solutions, but evidence for their effectiveness in digital ED therapy is sparse.
Objective:
This study aimed to systematically evaluate whether low-threshold digital support strategies — namely SMS-based reminders and structured telephone calls — can improve therapy adherence and patient-centered outcomes among users of a certified DiGA for erectile dysfunction.
Methods:
A total of 470 men with physician-diagnosed ED were quasi-randomly assigned to one of three groups: a control group (no additional support), an SMS group (text reminders after inactivity), and a call group (structured telephone contact following inactivity). The primary endpoint was the number of active training weeks during a 12-week therapy period. Secondary endpoints included Clinical Global Impression Improvement (CGI-I), changes in IIEF-5 (International Index of Erectile Functioning) scores, therapy continuation intent, and actual therapy continuation (conversion).
Results:
Patients completed a mean of 6.34 (SD = 4.44) active weeks. The SMS group showed significantly greater adherence than the control group (mean = 6.80 vs. 5.79 weeks, p = .049, Cohen’s d = -0.223). No significant mean differences were observed between control and call groups (p = .110), but a trend towards reduced variance suggests greater behavioral consistency. The call group showed a significantly higher intent to continue therapy (49% vs. 38%, p = .035), although conversion rates did not differ significantly. Group differences in CGI-I and IIEF improvements were not statistically significant, likely reflecting the impact of lower response rates.
Conclusions:
Low-threshold digital interventions can effectively enhance adherence and motivation in digital ED therapies. While text message reminders are a cost-effective way to increase activity, telephone contacts are suitable for promoting longer-term adherence to therapy. These findings can contribute to the optimization of digital care models for patients.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.