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To Text or Not to Text: Electronic Message Intervention to Improve Treatment Adherence Versus Matched Historical Controls.

ABSTRACT: BACKGROUND:Ensuring treatment adherence is important for the internal validity of clinical trials. In intervention studies where touch points decrease over time, there is even more of an adherence challenge. Trials with multiple cohorts offer an opportunity to innovate on ways to increase treatment adherence without compromising the integrity of the study design, and previous cohorts can serve as historical controls. Electronically delivered nudges offer low-cost opportunities to increase treatment adherence. OBJECTIVE:This study aimed to evaluate the effectiveness of electronic messages (e-messages) on treatment adherence to the last cohort of a parent weight loss intervention during the second half of a year-long trial, when intervention checkpoint frequency decreases. Treatment adherence is measured by intervention class attendance and adherence to the intervention diet. METHODS:All participants in the last cohort (cohort 5, n=128) of a large randomized weight loss study were offered an e-message intervention to improve participant adherence during the last 6 months of a 1-year weight loss program. Overall, 3 to 4 electronic weekly messages asked participants about intervention diet adherence. A propensity score model was estimated using 97 participants who opted to receive e-messages and 31 who declined in cohort 5 and used to pair match cohort 5 e-message participants to a historical control group from cohorts 1 to 4. Moreover, 88 participants had complete data, yielding 176 participants in the final analyses. After matching, intervention and matched control groups were compared on (1) proportion of class attendance between the 6 and 12 month study endpoints, (2) diet adherence, as measured by total carbohydrate grams for low-carbohydrate (LC) and total fat grams for low-fat (LF) diets at 12 months, and (3) weight change from 6 to 12 months. The dose-response relationship between the proportion of text messages responded to and the 3 outcomes was also investigated. RESULTS:Compared with matched controls, receiving e-messages had no effect on (1) treatment adherence; class attendance after 6 months +4.6% (95% CI -4.43 to 13.68, P=.31), (2) adherence; LC -2.5 g carbohydrate, 95% CI -29.9 to 24.8, P=.85; LF +6.2 g fat, 95% CI -4.1 to 17.0, P=.26); or on (3) the secondary outcome of weight change in the last 6 months; +0.3 kg (95% CI -1.0 to 1.5, P=.68). There was a positive significant response correlation between the percentage of messages to which participants responded and class attendance (r=.45, P<.001). CONCLUSIONS:Although this e-message intervention did not improve treatment adherence, future studies can learn from this pilot and may incorporate more variety in the prompts and more interaction to promote more effective user engagement. Uniquely, this study demonstrated the potential for innovating within a multicohort trial using propensity score-matched historical control subjects. TRIAL REGISTRATION:ClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1016/j.cct.2016.12.021.

SUBMITTER: Oppezzo MA

PROVIDER: S-EPMC6534047 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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To Text or Not to Text: Electronic Message Intervention to Improve Treatment Adherence Versus Matched Historical Controls.

Oppezzo Marily A MA Stanton Michael V MV Garcia Ariadna A Rigdon Joseph J Berman Jae R JR Gardner Christopher D CD

JMIR mHealth and uHealth 20190409 4

<h4>Background</h4>Ensuring treatment adherence is important for the internal validity of clinical trials. In intervention studies where touch points decrease over time, there is even more of an adherence challenge. Trials with multiple cohorts offer an opportunity to innovate on ways to increase treatment adherence without compromising the integrity of the study design, and previous cohorts can serve as historical controls. Electronically delivered nudges offer low-cost opportunities to increas ...[more]

PMID: 30964436

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Project description:AbstractAs access to human immunodeficiency virus treatment expands in Low to Middle Income Countries, it becomes critical to develop and test strategies to improve adherence and ensure efficacy. Text messaging improves adherence to antiretroviral treatment antiretroviral treatment in some patient populations, but data surrounding the use of these tools is sparse in pediatric and adolescent patients in low to middle income countries. We evaluated if a text message intervention can improve antiretroviral treatment adherence while accounting for cell phone access, patterns of use, and willingness to receive text messages.We carried out a cross sectional study to understand willingness of receiving text message reminders, followed by a randomized controlled trial to assess effectiveness of text message intervention.Enrolled participants were randomized to receive standard care with regular clinic visits, or standard care plus short message service reminders. Adherence was measured 3 times during the study period using a 4-day Recall Questionnaire. Outcome was measured based on differences in the average adherence between the intervention and control group at each time point (baseline, 3 months, 6 months).Most respondents were willing to receive text message adherence reminders (81.1%, n = 53). Respondent literacy, travel time to clinic, cell phone access, and patterns of use were significantly associated with willingness. In the randomized trial the intervention group (n = 50) experienced a small but significant mean improvement in adherence over the six-month period (4%, P < .01) whereas the control group (n = 50) did not (mean improvement: 0.8%, P = .64).Text message interventions effectively support antiretroviral adherence in pediatric patients living with human immunodeficiency virus. Studies designed to assess the impact of text messaging interventions must examine local context for cellular phone infrastructure and use and must account for potential loss to follow up when patients miss appointments and study assessments.

Project description:BackgroundMost individuals with heart disease struggle to adhere to cardiovascular health behaviors, despite their known health benefits. Text message interventions (TMIs) are a promising treatment modality for health behavior promotion, but existing TMIs typically deliver a fixed set of messages and do not target well-being constructs associated with adherence and cardiovascular health.ObjectiveTo develop a 4-week TMI, which delivers daily messages to promote well-being and adherence to health behaviors and dynamically adapts based on participant feedback to deliver increasingly customized messages; and to assess its feasibility, acceptability, and preliminary efficacy in a single-arm, proof-of-concept trial in 14 individuals with coronary artery disease (age mean = 67.9, standard deviation = 8.7).MethodsParticipants received daily text messages related to well-being, physical activity, or diet, rated each message's utility, and these ratings informed the TMI's choice of future text messages. Feasibility was assessed by the proportion of messages successfully sent, and acceptability was assessed by participant ratings of intervention burden and text message utility. Finally, the intervention's preliminary efficacy was explored by measuring pre-post changes in psychologic and behavioral outcomes.ResultsThe TMI was both feasible (93% of participants received all messages) and well-accepted (mean text message utility: 7.0 of 10 [standard deviation 2.5]; mean intervention utility: 6.4 of 10 [standard deviation 0.9]; mean intervention burden: 0.5 of 10 [standard deviation 0.9]). Participants reported that messages related to well-being were particularly helpful and that most messages led to an action (e.g., eating more vegetables, being kind to others). The TMI led to nonsignificant, small-to-medium effect size improvements in happiness, optimism, determination, depression, anxiety, self-rated health, and diet (d = 0.19-0.48), and, unexpectedly, small reductions in activity and physical function (d = -0.20 and -0.32).ConclusionsThe adaptive TMI was feasible, well-accepted, and associated with nonsignificant improvements in psychologic outcomes and mixed effects on behavioral outcomes. Larger, well-powered studies are needed to determine whether this TMI will be able to improve well-being and health-related outcomes in this high-risk population.

Project description:Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.NCT02019823.

Project description:BackgroundHypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population.ObjectiveThe purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN.MethodsIn Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention.ResultsAlthough data collection is now complete, data analysis from the two pilot RCTs is still ongoing and results are expected in 2015.ConclusionsThis study was designed to determine preliminary feasibility and acceptability of our approach among African Americans with uncontrolled HTN in primary care and emergency department settings. Results from these studies are of great interest as little work has been done to document the use of text message medication reminders to improve HTN-related outcomes, particularly within underserved urban minorities.Trial registrationClinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ).

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To Text or Not to Text: Electronic Message Intervention to Improve Treatment Adherence Versus Matched Historical Controls.

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To Text or Not to Text: Electronic Message Intervention to Improve Treatment Adherence Versus Matched Historical Controls.

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