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

Novel implementation strategy to electronically screen and signpost patients to health behavior apps: Mixed methods implementation study (OptiMine study)

BACKGROUND: Behavior change apps have the potential to provide individual support on a population scale at low cost, but they face numerous barriers to implementation. Electronic health records (EHRs) in acute care hospitals provide a valuable resource for identifying patients at risk, who may benefit from behavior change apps. A novel, emerging implementation strategy is to use digital technologies not only for providing support to help-seeking individuals but also for signposting patients at risk to support services (also called proactive referral in the United States). OBJECTIVE: The OptiMine study aimed to increase the reach of behavior change apps by implementing electronic signposting for smoking cessation and alcohol reduction in a large, at-risk population that was identified through an acute care hospital EHR. METHODS: This 3-phase, mixed methods implementation study assessed the acceptability, feasibility, and reach of electronic signposting to behavior change apps by using a hospital\u27s EHR system to identify patients who are at risk. Phase 1 explored the acceptability of the implementation strategy among the patients and staff through focus groups. Phase 2 investigated the feasibility of using the hospital EHR to identify patients with target risk behaviors and contact them via SMS text message, email, or patient portal. Phase 3 assessed the impact of SMS text messages sent to patients who were identified as smokers or risky drinkers, which signposted them to behavior change apps. The primary outcome was the proportion of participants who clicked on the embedded link in the SMS text message to access information about the apps. The acceptability of the SMS text messages among the patients who had received them was also explored in a web-based survey. RESULTS: Our electronic signposting strategy-using SMS text messages to promote health behavior change apps to patients at risk-was found to be acceptable and feasible and had good reach. The hospital sent 1526 SMS text messages, signposting patients to either the National Health Service Smokefree or Drink Free Days apps. A total of 13.56% (207/1526) of the patients clicked on the embedded link to the apps, which exceeded our 5% a priori success criterion. Patients and staff contributed to the SMS text message content and delivery approach, which were perceived as acceptable before and after the delivery of the SMS text messages. The feasibility of the SMS text message format was determined and the target population was identified by mining the EHR. CONCLUSIONS: The OptiMine study demonstrated the proof of concept for this novel implementation strategy, which used SMS text messages to signpost at-risk individuals to behavior change apps at scale. The level of reach exceeded our a priori success criterion in a non-help-seeking population of patients receiving unsolicited SMS text messages, disconnected from hospital visits. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/23669

Mobile Phone Text Messages to Support People to Stop Smoking by Switching to Vaping: Codevelopment, Coproduction, and Initial Testing Study

Background: SMS text messages are affordable, scalable, and effective smoking cessation interventions. However, there is little research on SMS text message interventions specifically designed to support people who smoke to quit by switching to vaping. Objective: Over 3 phases, with vapers and smokers, we codeveloped and coproduced a mobile phone SMS text message program. The coproduction paradigm allowed us to collaborate with researchers and the community to develop a more relevant, acceptable, and equitable SMS text message program. Methods: In phase 1, we engaged people who vape via Twitter and received 167 responses to our request to write SMS text messages for people who wish to quit smoking by switching to vaping. We screened, adjusted, refined, and themed the messages, resulting in a set of 95 that were mapped against the Capability, Opportunity, and Motivation–Behavior constructs. In phase 2, we evaluated the 95 messages from phase 1 via a web survey where participants (66/202, 32.7% woman) rated up to 20 messages on 7-point Likert scales on 9 constructs: being understandable, clear, believable, helpful, interesting, inoffensive, positive, and enthusiastic and how happy they would be to receive the messages. In phase 3, we implemented the final set of SMS text messages as part of a larger randomized optimization trial, in which 603 participants (mean age 38.33, SD 12.88 years; n=369, 61.2% woman) received SMS text message support and then rated their usefulness and frequency and provided free-text comments at the 12-week follow-up. Results: For phase 2, means and SDs were calculated for each message across the 9 constructs. Those with means below the neutral anchor of 4 or with unfavorable comments were discussed with vapers and further refined or removed. This resulted in a final set of 78 that were mapped against early, mid-, or late stages of quitting to create an order for the messages. For phase 3, a total of 38.5% (232/603) of the participants provided ratings at the 12-week follow-up. In total, 69.8% (162/232) reported that the SMS text messages had been useful, and a significant association between quit rates and usefulness ratings was found (χ21=9.6; P=.002). A content analysis of free-text comments revealed that the 2 most common positive themes were helpful (13/47, 28%) and encouraging (6/47, 13%) and the 2 most common negative themes were too frequent (9/47, 19%) and annoying (4/47, 9%). Conclusions: In this paper, we describe the initial coproduction and codevelopment of a set of SMS text messages to help smokers stop smoking by transitioning to vaping. We encourage researchers to use, further develop, and evaluate the set of SMS text messages and adapt it to target populations and relevant contexts

The OptiMine feasibility study: a novel implementation strategy to electronically screen and signpost patients to health behaviour apps

Background: Behavior change apps have the potential to provide individual support on a population scale at low cost, but they face numerous barriers to implementation. Electronic health records (EHRs) in acute care hospitals provide a valuable resource for identifying patients at risk, who may benefit from behavior change apps. A novel, emerging implementation strategy is to use digital technologies not only for providing support to help-seeking individuals but also for signposting patients at risk to support services (also called proactive referral in the United States). Objective: The OptiMine study aimed to increase the reach of behavior change apps by implementing electronic signposting for smoking cessation and alcohol reduction in a large, at-risk population that was identified through an acute care hospital EHR. Methods: This 3-phase, mixed methods implementation study assessed the acceptability, feasibility, and reach of electronic signposting to behavior change apps by using a hospital’s EHR system to identify patients who are at risk. Phase 1 explored the acceptability of the implementation strategy among the patients and staff through focus groups. Phase 2 investigated the feasibility of using the hospital EHR to identify patients with target risk behaviors and contact them via SMS text message, email, or patient portal. Phase 3 assessed the impact of SMS text messages sent to patients who were identified as smokers or risky drinkers, which signposted them to behavior change apps. The primary outcome was the proportion of participants who clicked on the embedded link in the SMS text message to access information about the apps. The acceptability of the SMS text messages among the patients who had received them was also explored in a web-based survey. Results: Our electronic signposting strategy—using SMS text messages to promote health behavior change apps to patients at risk—was found to be acceptable and feasible and had good reach. The hospital sent 1526 SMS text messages, signposting patients to either the National Health Service Smokefree or Drink Free Days apps. A total of 13.56% (207/1526) of the patients clicked on the embedded link to the apps, which exceeded our 5% a priori success criterion. Patients and staff contributed to the SMS text message content and delivery approach, which were perceived as acceptable before and after the delivery of the SMS text messages. The feasibility of the SMS text message format was determined and the target population was identified by mining the EHR. Conclusions: The OptiMine study demonstrated the proof of concept for this novel implementation strategy, which used SMS text messages to signpost at-risk individuals to behavior change apps at scale. The level of reach exceeded our a priori success criterion in a non–help-seeking population of patients receiving unsolicited SMS text messages, disconnected from hospital visits. International Registered Report Identifier (IRRID): RR2-10.2196/2366

Mobile Phone Text Messages to Support People to Stop Smoking by Switching to Vaping: Codevelopment, Coproduction, and Initial Testing Study.

SMS text messages are affordable, scalable, and effective smoking cessation interventions. However, there is little research on SMS text message interventions specifically designed to support people who smoke to quit by switching to vaping. Over 3 phases, with vapers and smokers, we codeveloped and coproduced a mobile phone SMS text message program. The coproduction paradigm allowed us to collaborate with researchers and the community to develop a more relevant, acceptable, and equitable SMS text message program. In phase 1, we engaged people who vape via Twitter and received 167 responses to our request to write SMS text messages for people who wish to quit smoking by switching to vaping. We screened, adjusted, refined, and themed the messages, resulting in a set of 95 that were mapped against the Capability, Opportunity, and Motivation-Behavior constructs. In phase 2, we evaluated the 95 messages from phase 1 via a web survey where participants (66/202, 32.7% woman) rated up to 20 messages on 7-point Likert scales on 9 constructs: being understandable, clear, believable, helpful, interesting, inoffensive, positive, and enthusiastic and how happy they would be to receive the messages. In phase 3, we implemented the final set of SMS text messages as part of a larger randomized optimization trial, in which 603 participants (mean age 38.33, SD 12.88 years; n=369, 61.2% woman) received SMS text message support and then rated their usefulness and frequency and provided free-text comments at the 12-week follow-up. For phase 2, means and SDs were calculated for each message across the 9 constructs. Those with means below the neutral anchor of 4 or with unfavorable comments were discussed with vapers and further refined or removed. This resulted in a final set of 78 that were mapped against early, mid-, or late stages of quitting to create an order for the messages. For phase 3, a total of 38.5% (232/603) of the participants provided ratings at the 12-week follow-up. In total, 69.8% (162/232) reported that the SMS text messages had been useful, and a significant association between quit rates and usefulness ratings was found (χ =9.6; P=.002). A content analysis of free-text comments revealed that the 2 most common positive themes were helpful (13/47, 28%) and encouraging (6/47, 13%) and the 2 most common negative themes were too frequent (9/47, 19%) and annoying (4/47, 9%). In this paper, we describe the initial coproduction and codevelopment of a set of SMS text messages to help smokers stop smoking by transitioning to vaping. We encourage researchers to use, further develop, and evaluate the set of SMS text messages and adapt it to target populations and relevant contexts. [Abstract copyright: ©Vassilis Sideropoulos, Eleni Vangeli, Felix Naughton, Sharon Cox, Daniel Frings, Caitlin Notley, Jamie Brown, Catherine Kimber, Lynne Dawkins. Originally published in JMIR Formative Research (https://formative.jmir.org), 27.09.2023.

Using the Medical Research Council framework for development and evaluation of complex interventions in a low resource setting to develop a theory-based treatment support intervention delivered via SMS text message to improve blood pressure control

Several frameworks now exist to guide intervention development but there remains only limited evidence of their application to health interventions based around use of mobile phones or devices, particularly in a low-resource setting. We aimed to describe our experience of using the Medical Research Council (MRC) Framework on complex interventions to develop and evaluate an adherence support intervention for high blood pressure delivered by SMS text message. We further aimed to describe the developed intervention in line with reporting guidelines for a structured and systematic description

The Feasibility of a Using a Smart Button Mobile Health System to Self-Track Medication Adherence and Deliver Tailored Short Message Service Text Message Feedback

BACKGROUND: As many as 50% of people experience medication nonadherence, yet studies for detecting nonadherence and delivering real-time interventions to improve adherence are lacking. Mobile health (mHealth) technologies show promise to track and support medication adherence. OBJECTIVE: The study aimed to evaluate the feasibility and acceptability of using an mHealth system for medication adherence tracking and intervention delivery. The mHealth system comprises a smart button device to self-track medication taking, a companion smartphone app, a computer algorithm used to determine adherence and then deliver a standard or tailored SMS (short message service) text message on the basis of timing of medication taking. Standard SMS text messages indicated that the smartphone app registered the button press, whereas tailored SMS text messages encouraged habit formation and systems thinking on the basis of the timing the medications were taken. METHODS: A convenience sample of 5 adults with chronic kidney disease (CKD), who were prescribed antihypertensive medication, participated in a 52-day longitudinal study. The study was conducted in 3 phases, with a standard SMS text message sent in phases 1 (study days 1-14) and 3 (study days 46-52) and tailored SMS text messages sent during phase 2 (study days 15-45) in response to participant medication self-tracking. Medication adherence was measured using: (1) the smart button and (2) electronic medication monitoring caps. Concordance between these 2 methods was evaluated using percentage of measurements made on the same day and occurring within ±5 min of one another. Acceptability was evaluated using qualitative feedback from participants. RESULTS: A total of 5 patients with CKD, stages 1-4, were enrolled in the study, with the majority being men (60%), white (80%), and Hispanic/Latino (40%) of middle age (52.6 years, SD 22.49; range 20-70). The mHealth system was successfully initiated in the clinic setting for all enrolled participants. Of the expected 260 data points, 36.5% (n=95) were recorded with the smart button and 76.2% (n=198) with electronic monitoring. Concordant events (n=94), in which events were recorded with both the smart button and electronic monitoring, occurred 47% of the time and 58% of these events occurred within ±5 min of one another. Participant comments suggested SMS text messages were encouraging. CONCLUSIONS: It was feasible to recruit participants in the clinic setting for an mHealth study, and our system was successfully initiated for all enrolled participants. The smart button is an innovative way to self-report adherence data, including date and timing of medication taking, which were not previously available from measures that rely on recall of adherence. Although the selected smart button had poor concordance with electronic monitoring caps, participants were willing to use it to self-track medication adherence, and they found the mHealth system acceptable to use in most cases

Response Parameters for SMS Text Message Assessments Among Pregnant and General Smokers Participating in SMS Cessation Trials.

INTRODUCTION: Despite a substantial increase in use of SMS text messages for collecting smoking-related data, there is limited knowledge on the parameters of response. This study assessed response rates, response speed, impact of reminders and predictors of response to text message assessments among smokers. METHODS: Data were from two SMS cessation intervention trials using clinical samples of pregnant (n = 198) and general smokers (n = 293) sent text message assessments during 3-month cessation programs. Response rates were calculated using data from the host web-server. Changes in response over time, impact of reminders and potential demographic (age, gender, ethnicity, parity, and deprivation) and smoking (nicotine dependence, determination to quit, prenatal smoking history, smoking status at follow-up) predictors of response were analyzed. RESULTS: Mean response rates were 61.9% (pregnant) and 67.8% (general) with aggregated median response times of 0.35 (pregnant) and 0.64 (general) hours. Response rate reduced over time (P = .003) for general smokers only. Text message reminders had a significant effect on response (Ps < .001), with observed mean increases of 13.8% (pregnant) and 17.7% (general). Age (odds ratio [OR] = 0.95, 95% confidence interval [CI] 0.90-1.00) and deprivation (OR = 0.98, 95% CI 0.96-1.00) weakly predicted response among pregnant smokers and nonsmoking status at 4 weeks follow-up (OR = 8.63, 95% CI 3.03-24.58) predicted response among general smokers. CONCLUSIONS: Text message assessments within trial-based cessation programs yield rapid responses from a sizable proportion of smokers, which can be increased using text reminders. While few sources of nonresponse bias were identified for general smokers, older and more deprived pregnant women were less likely to respond. IMPLICATIONS: This study demonstrates that most pregnant and general smokers enrolled in a cessation trial will respond to a small number of questions about their smoking sent by text message, mostly within 1 hour of being sent the assessment text message. For those who do not initially respond, our findings suggest that 24- and 48-hour text message reminders are likely to increase response a small but meaningful amount. However, older age and higher deprivation among pregnant smokers and relapse among general smokers is likely to reduce the chance of response.The MiQuit feasibility trial was funded by Cancer Research UK (CR-UK) grant number C1345/A5809. The iQuit in Practice trial was funded by the National Institute for Health Research (NIHR) School for Primary Care Research (SPCR).This is the final version of the article. It first appeared from Oxford University Press via http://dx.doi.org/10.1093/ntr/ntv26

Improving treatment adherence for blood pressure lowering via mobile phone SMS-messages in South Africa: a qualitative evaluation of the SMS-text Adherence SuppoRt (StAR) trial

BACKGROUND:Effective use of proven treatments for high blood pressure, a preventable health risk, is challenging for many patients. Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment, though more research is needed on impact and patient perceptions of such support interventions, especially in low-resource settings.METHOD:An individually-randomised controlled trial in a primary care clinic in Cape Town (2012-14), tested the effect of an adherence support intervention delivered via SMS-texts, on blood pressure control and adherence to medication, for hypertensive patients. (Trial registration: ClinicalTrials.gov NCT02019823). We report on a qualitative evaluation that explored the trial participants' experiences and responses to the SMS-text messages, and identified barriers and facilitators to delivering adherence support via patients' own mobile phones. Two focus groups and fifteen individual interviews were conducted. We used comparative and thematic analysis approaches to identify themes and triangulated our analysis amongst three researchers. RESULTS: Most participants were comfortable with the technology of using SMS-text messages. Messages were experienced as acceptable, relevant and useful to a broad range of participants. The SMS-content, the respectful tone and the delivery (timing of reminders and frequency) and the relational aspect of trial participation (feeling cared for) were all highly valued. A subgroup who benefitted the most, were those who had been struggling with adherence due to high levels of personal stress. The intervention appeared to coincide with their readiness for change, and provided practical and emotional support for improving adherence behaviour. Change may have been facilitated through increased acknowledgement of their health status and attitudinal change towards greater self-responsibility. Complex interaction of psycho-social stressors and health service problems were reported as broader challenges to adherence behaviours. CONCLUSION: Adherence support for treatment of raised blood pressure, delivered via SMS-text message on the patient's own phone, was found to be acceptable, relevant and helpful, even for those who already had their own reminder systems in place. Our findings begin to identify for whom and what core elements of the SMS-text message intervention appear to work best in a low-resource operational setting, issues that future research should explore in greater depth

Mobile information communication technology for crisis management : understanding user behavior, response and training

SMS text-messaging is an interoperable communication vehicle known to be dependable for mass media alert notifications in crisis management. SMS text-messaging also offers potential as one viable two-way communication alternative for field responders in crisis response. Both continuously changing mobile information communication technologies and the importance of precise information exchange constitute a need for communication protocol training and practice. This study introduces a technology-mediated training technique based on speech act and communicative action theories. These theories are used to inform the design of a baseline measure for task performance improvement and to suggest a model to predict communication readiness. Because this research bridges two fields - information systems and communication - it provides a model for full construct-representation of text-based interaction in a technology-mediated environment. The proposed model is validated through a web-based training application with 50 participants who have different crisis response backgrounds, including emergency management practitioners, first responders, public safety volunteers, community volunteers, community citizens, and students over the age of 18. Each group encompasses diverse technological skill and usage levels. The web-based training application developed in the present study features plain language training so that a clear understanding of user behavior, response, and training would emerge. The training and crisis scenario are rendered through multimedia recordings and designed to measure task response, based on the 160 character per SMS text-message exchange limit. The mixed-methods design begins with a crisis scenario, followed by pre-training measures, three repeated training measures, and concludes with post-training measures. A total of six tasks are introduced (3 pre-training and 3 post-training) in which each participant interfaces with the web-based training application through a high-speed Internet connection. Task response level results show promise for this exploratory research and contribute to a new discourse mode that extends to mobile technology penetration. Future research will focus on refinement of the model\u27s task performance measures and will seek to introduce additional situation-based scenarios and mixed-modes of communication. During this next research phase, the objective is to incorporate the model into mobile device usage and operationalize the model in authentic crisis management contexts. If successful in extended field simulation, the model may have the potential to ensure effective mobile information communication within the context of crisis