title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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<.001) and more often women (2103/4181, 50.30%) than those who were not eligible (age: mean 43.7, SD 14.6 years; women: 3633/6514, 55.78%). At the point when potential participants were asked to give consent, a further 2278 refused. Those who refused were a little older (mean 40.2, SD 13.9 years) than those who agreed to participate (mean 38.3, SD 12.5 years; t1842=3.2, P<.001). We measured the outcomes after 12 months of the SMS text message intervention. Attrition from the SMS text message intervention was 4.8% (27/563). The patient dropout rate after 12 months was 0.36% (4/1123), as discovered from the register data. In all, 3.12% (35/1123) of the participants withdrew from the trial. However, dropout rates from the patient survey (either by paper or telephone interview) were 52.45% (589/1123) and 27.8% (155/558), respectively. Almost all participants (536/563, 95.2%) tolerated the intervention, but those who discontinued were more often women (21/27, 78%; P=.009). Finally, participants' age (P<.001), gender (P<.001), vocational education (P=.04), and employment status (P<.001) seemed to predict their risk of dropping out from the postal survey.
  
  
  
  Patient recruitment and engagement in the 12-month follow-up conducted with a postal survey were the most vulnerable phases in the SMS text message-based trial. People with serious mental health problems may need extra support during the recruitment process and in engaging them in SMS text message-based trials to ensure robust enough evidence for mental health care.
  
  
  
  International Standard Randomized Controlled Trial Number (ISRCTN): 27704027; http://www.isrctn.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/6oHcU2SFp).
authors.affiliation: Department of Nursing Science, University of Turku, Turku, Finland.|Satakunta Hospital District, Pori, Finland.
authors.forename: Kati Anneli
authors.identifier: 0000-0002-8357-8902
authors.initials: KA
authors.lastname: Kannisto
authors.affiliation: Department of Nursing Science, University of Turku, Turku, Finland.|Turku University of Applied Sciences, Turku, Finland.
authors.forename: Joonas
authors.identifier: 0000-0002-5324-1727
authors.initials: J
authors.lastname: Korhonen
authors.affiliation: Institute of Mental Health, Division of Psychiatry, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Clive E
authors.identifier: 0000-0003-1628-4020
authors.initials: CE
authors.lastname: Adams
authors.affiliation: Department of Nursing Science, University of Turku, Turku, Finland.|Satakunta Hospital District, Pori, Finland.
authors.forename: Marita Hannele
authors.identifier: 0000-0001-6485-4353
authors.initials: MH
authors.lastname: Koivunen
authors.affiliation: Department of Biostatistics, University of Turku, Turku, Finland.|Turku University Hospital, Turku, Finland.
authors.forename: Tero
authors.identifier: 0000-0002-4935-3056
authors.initials: T
authors.lastname: Vahlberg
authors.affiliation: Department of Nursing Science, University of Turku, Turku, Finland.|Turku University Hospital, Turku, Finland.|Hong Kong Polytechnic University, Hong Kong, China (Hong Kong).
authors.forename: Maritta Anneli
authors.identifier: 0000-0003-3124-9290
authors.initials: MA
authors.lastname: Välimäki
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D001523:Mental Disorders / Q000188:drug therapy* / Q000523:psychology*; D008875:Middle Aged; D010352:Patient Dropouts / Q000523:psychology*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D011795:Surveys and Questionnaires; D017216:Telemedicine / Q000379:methods*; D060145:Text Messaging / Q000706:statistics & numerical data
keywords: antipsychotics; mental health; methodological study; mobile health; psychiatric services; text messaging