Factors Associated With Dropout During Recruitment and Follow-Up Periods of a mHealth-Based Randomized Controlled Trial for Mobile.Net to Encourage Treatment Adherence for People With Serious Mental Health Problems

Kannisto, Kati Anneli; Korhonen, Joonas; Adams, Clive E.; Koivunen, Marita Hannele; Vahlberg, Tero; V�lim�ki, Maritta Anneli

Abstract

Background: Clinical trials are the gold standard of evidence-based practice. Still many papers inadequately report methodology in randomized controlled trials (RCTs), particularly for mHealth interventions for people with serious mental health problems. To ensure robust enough evidence, it is important to understand which study phases are the most vulnerable in the field of mental health care.

Objective: We mapped the recruitment and the trial follow-up periods of participants to provide a picture of the dropout predictors from a mHealth-based trial. As an example, we used a mHealth-based multicenter RCT, titled “Mobile.Net,” targeted at people with serious mental health problems.

Methods: Recruitment and follow-up processes of the Mobile.Net trial were monitored and analyzed. Recruitment outcomes were recorded as screened, eligible, consent not asked, refused, and enrolled. Patient engagement was recorded as follow-up outcomes: (1) attrition during short message service (SMS) text message intervention and (2) attrition during the 12-month follow-up period. Multiple regression analysis was used to identify which demographic factors were related to recruitment and retention.

Results: We recruited 1139 patients during a 15-month period. Of 11,530 people screened, 36.31% (n=4186) were eligible. This eligible group tended to be significantly younger (mean 39.2, SD 13.2 years, P

Citation

Kannisto, K. A., Korhonen, J., Adams, C. E., Koivunen, M. H., Vahlberg, T., & Välimäki, M. A. (2017). Factors Associated With Dropout During Recruitment and Follow-Up Periods of a mHealth-Based Randomized Controlled Trial for Mobile.Net to Encourage Treatment Adherence for People With Serious Mental Health Problems. Journal of Medical Internet Research, 19(2), Article e46. https://doi.org/10.2196/jmir.6417

• Journal Article Type: Article
• Acceptance Date: Dec 5, 2016
• Online Publication Date: Feb 21, 2017
• Publication Date: 2017-02
• Deposit Date: Mar 2, 2018
• Publicly Available Date: Mar 2, 2018
• Electronic ISSN: 1438-8871
• Publisher: JMIR Publications
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Issue: 2
• Article Number: e46
• DOI: https://doi.org/10.2196/jmir.6417
• Keywords: text messaging; mobile health; antipsychotics; mental health; psychiatric services; methodological study
• Public URL: https://nottingham-repository.worktribe.com/output/844981
• Publisher URL: http://www.jmir.org/2017/2/e46/