Short Text Messages to Encourage Adherence to Medication and Follow-up for People With Psychosis (Mobile.Net): Randomized Controlled Trial in Finland.

BACKGROUND: A text messaging service (short message service [SMS]) has the potential to target large groups of people with long-term illnesses such as serious mental disorders, who may have difficulty with treatment adherence. Robust research on the impact of mobile technology interventions for these patients remains scarce. OBJECTIVE: The main objective of our study was to investigate the impact of individually tailored short text messages on the rate of psychiatric hospital readmissions, health care service use, and clinical outcomes. In addition, we analyzed treatment costs. METHODS: Between September 2011 and November 2012, we randomly assigned 1139 people to a tailored text message intervention (n=569) or usual care (n=570). Participants received semiautomated text messages for up to 12 months or usual care. The primary outcome, based on routinely collected health register data, was patient readmission into a psychiatric hospital during a 12-month follow-up period. Secondary outcomes were related to other service use, coercion, medication, adverse events, satisfaction, social functioning, quality of life, and economic factors (cost analysis). RESULTS: There was 98.24% (1119/1139) follow-up at 12 months. Tailored mobile telephone text messages did not reduce the rate of hospital admissions (242/563, 43.0% of the SMS group vs 216/556, 38.8% of the control group; relative risk 1.11; 95% CI 0.92-1.33; P=.28), time between hospitalizations (mean difference 7.0 days 95% CI -8.0 to 24.0; P=.37), time spent in a psychiatric hospital during the year (mean difference 2.0 days 95% CI -2.0 to 7.0; P=.35), or other service outcomes. People who received text messages were less disabled, based on Global Assessment Scale scores at the time of their readmission, than those who did not receive text messages (odds ratio 0.68; 95% CI 0.47-0.97; P=.04). The costs of treatment were higher for people in the SMS group than in the control group (mean €10,103 vs €9210, respectively, P<.001). CONCLUSIONS: High-grade routinely collected data can provide clear outcomes for pragmatic randomized trials. SMS messaging tailored with the input of each individual patient did not decrease the rate of psychiatric hospital visits after the 12 months of follow-up. Although there may have been other, more subtle effects, the results of these were not evident in outcomes of agreed importance to clinicians, policymakers, and patients and their families. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 27704027; http://www.isrctn.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/6rVzZrbuz).

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.

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<.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. CONCLUSIONS: 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. CLINICALTRIAL: International Standard Randomized Controlled Trial Number (ISRCTN): 27704027; http://www.isrctn.com/ISRCTN27704027 (Archived by WebCite at http://www.webcitation.org/6oHcU2SFp).

Feedback on SMS reminders to encourage adherence among patients taking antipsychotic medication: a cross-sectional survey nested within a randomised trial.

OBJECTIVES: To explore feedback on tailored SMS reminders to encourage medication adherence and outpatient treatment among patients taking antipsychotic medication, and associations related to the feedback. DESIGN: A cross-sectional survey nested within a nationwide randomised clinical trial ("Mobile.Net" ISRCTN27704027). SETTING: Psychiatric outpatient care in Finland. PARTICIPANTS: Between September 2012 and December 2013, 403 of 558 adults with antipsychotic medication responded after 12 months of SMS intervention. MAIN OUTCOME MEASURE: Feedback was gathered with a structured questionnaire based on Technology Acceptance Model theory. Data were analysed by Pearson's χ(2) test, binary logistic regression and stepwise multiple regression analyses. RESULTS: Almost all participants (98%) found the SMS reminders easy to use and 87% felt that the SMS did not cause harm. About three-quarters (72%) were satisfied with the SMS received, and 61% found it useful. Divorced people were particularly prone to find SMS reminders useful (χ(2)=13.17, df=6, p=0.04), and people seeking employment were more often 'fully satisfied' with the SMS compared with other groups (χ(2)=10.82, df=4, p=0.029). People who were older at first contact with psychiatric services were more often 'fully satisfied' than younger groups (OR=1.02, 95% CI 1.01 to 1.04, p=0.007). CONCLUSIONS: The feedback of patients taking antipsychotic medication on SMS services was generally positive. Overall, people were quite satisfied despite considerable variation in their sociodemographic background and illness history. Our results endorse that the use of simple easy-to-use existing technology, such as mobile phones and SMS, is acceptable in psychiatric outpatient services. Moreover, people using psychiatric outpatient services are able to use this technology. This acceptable and accessible technology can be easily tailored to each patient's needs and could be customised to the needs of the isolated or jobless. This is an area in which much careful evaluation is needed.

Use of mobile phone text message reminders in health care services: a narrative literature review.

BACKGROUND: Mobile text messages are a widely recognized communication method in societies, as the global penetration of the technology approaches 100% worldwide. Systematic knowledge is still lacking on how the mobile telephone text messaging (short message service, SMS) has been used in health care services. OBJECTIVE: This study aims to review the literature on the use of mobile phone text message reminders in health care. METHODS: We conducted a systematic literature review of studies on mobile telephone text message reminders. The data sources used were PubMed (MEDLINE), CINAHL, Proquest Databases/ PsycINFO, EMBASE, Cochrane Library, Scopus, and hand searching since 2003. Studies reporting the use of SMS intended to remind patients in health services were included. Given the heterogeneity in the studies, descriptive characteristics, purpose of the study, response rates, description of the intervention, dose and timing, instruments, outcome measures, and outcome data from the studies were synthesized using a narrative approach. RESULTS: From 911 initial citations, 60 studies were included in the review. The studies reported a variety of use for SMS. Mobile telephone text message reminders were used as the only intervention in 73% (44/60) of the studies, and in 27% (16/60) of the remaining studies, SMS was connected to another comprehensive health intervention system. SMS reminders were sent to different patient groups: patients with HIV/AIDS (15%, 9/60) and diabetes (13%, 8/60) being the most common groups. The response rates of the studies varied from 22-100%. Typically, the text message reminders were sent daily. The time before the specific intervention to be rendered varied from 10 minutes (eg, medication taken) to 2 weeks (eg, scheduled appointment). A wide range of different evaluation methods and outcomes were used to assess the impact of SMS varying from existing databases (eg, attendance rate based on medical records), questionnaires, and physiological measures. About three quarters of the studies (77%, 46/60) reported improved outcomes: adherence to medication or to treatment reportedly improved in 40% (24/60) of the studies, appointment attendance in 18% (11/60) of the studies, and non-attendance rates decreased in 18% (11/60) of the studies. Other positive impacts were decreased amount of missed medication doses, more positive attitudes towards medication, and reductions in treatment interruptions. CONCLUSIONS: We can conclude that although SMS reminders are used with different patient groups in health care, SMS is less systematically studied with randomized controlled trial study design. Although the amount of evidence for SMS application recommendations is still limited, having 77% (46/60) of the studies showing improved outcomes may indicate its use in health care settings. However, more well-conducted SMS studies are still needed.