Retaining diverse adults with diabetes in a long-term trial: Strategies, successes, and lessons learned.

Background Retention can be difficult in longitudinal trials, especially among minoritized groups and individuals with low socioeconomic status (SES) who may experience more barriers to research participation. Organized retention strategies may help; however, limited research has reported on this in detail. Methods We employed several strategies throughout a 15-month randomized controlled trial to encourage retention among a diverse sample of adults with type 2 diabetes. Participants were randomized to receive mobile health support for diabetes self-care for 12 months or an attention control. Participants completed assessments at 3, 6, 12, and 15 months post-baseline. We used three main categories of retention strategies: flexibility in participation (e.g., multiple methods for data collection), communication (e.g., tracking contacts), and community building (e.g., study branding, newsletters). We monitored participants' use of strategies and examined associations between participant characteristics and retention. Results Retention remained high (≥90%) at each follow-up assessment. Participants used various methods for survey completion: online (34%), in-person (31%), and mail (30%). Most (73%) used a mail-in A1c kit at least once. Multiple completion methods were important for retaining minoritized and lower SES participants who completed assessments in-person more frequently. Communication also facilitated retention; 39% of participants used a study Helpline and tracking systems helped maintain contact. Conclusions Retaining disadvantaged patients in clinical trials is necessary so findings generalize to and can benefit these populations. Retention strategies that reduce barriers to participation and engage participants and community partners can be successful. Future studies should assess the impact of retention strategies.

Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial.

OBJECTIVE: Text messaging interventions have high potential for scalability and for reductions in health disparities. However, more rigorous, long-term trials are needed. We examined the long-term efficacy and mechanisms of a tailored text messaging intervention. RESEARCH DESIGN AND METHODS: Adults with type 2 diabetes participated in a parallel-groups, 15-month randomized controlled trial and were assigned to receive Rapid Education/Encouragement and Communications for Health (REACH) for 12 months or control. REACH included interactive texts and tailored texts addressing medication adherence and nontailored texts supporting other self-care behaviors. Outcomes included hemoglobin A1c (HbA1c), diabetes medication adherence, self-care, and self-efficacy. RESULTS: Participants (N = 506) were approximately half racial/ethnic minorities, and half were underinsured, had annual household incomes <$35,000, and had a high school education or less; 11% were homeless. Average baseline HbA1c was 8.6% ± 1.8%; 70.0 ± 19.7 mmol/mol) with n = 219 having HbA1c ≥8.5% (69 mmol/mol). Half were prescribed insulin. Retention was over 90%. Median response rate to interactive texts was 91% (interquartile range 75%, 97%). The treatment effect on HbA1c at 6 months (-0.31%; 95% CI -0.61%, -0.02%) was greater among those with baseline HbA1c ≥8.5% (-0.74%; 95% CI -1.26%, -0.23%), and there was no evidence of effect modification by race/ethnicity or socioeconomic disadvantage. REACH improved medication adherence and diet through 12 months and self-efficacy through 6 months. Treatment effects were not significant for any outcome at 15 months. REACH reduced barriers to adherence, but barrier reduction did not mediate outcome improvements. CONCLUSIONS: REACH engaged at-risk patients in diabetes self-management and improved short-term HbA1c. More than texts alone may be needed to sustain the effects.

Implementation of Technology-Delivered Diabetes Self-care Interventions in Clinical Care: a Narrative Review.

PURPOSE OF REVIEW: Evidence is growing for the positive effects of technology-delivered diabetes self-care interventions on behavioral and clinical outcomes. However, our understanding of how to effectively implement these interventions into routine clinical practice is limited. This article provides an overview of the methods and results of studies examining the implementation of technology-delivered diabetes self-care interventions into clinical care. We focus specifically on patient-facing behavioral interventions delivered with technology (e.g., text messaging, apps, websites). RECENT FINDINGS: Eleven articles were included in the review. Most studies (n = 9) examined barriers and facilitators to implementation, while about half (n = 5) integrated the intervention into clinical care and evaluated implementation and/or effectiveness. Only six studies applied a theory or framework. The most common determinants of implementation were time constraints for clinic staff, familiarity with technology, knowledge of the intervention, and perceived value. We found substantial variation in implementation outcomes, including which were reported, how they were assessed, and the results. In the four studies that evaluated effectiveness, hemoglobin A1c improved. Successful implementation of technology-delivered interventions has the potential to transform healthcare delivery and improve diabetes health on a population level. Promising strategies to address common determinants of implementation include appointing a clinic champion, developing staff training and educational materials, and adapting intervention processes to the clinic context. Future research should evaluate these implementation strategies to understand when and how they impact outcomes. Frameworks such as Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) can help ensure outcomes are systematically reported and allow for comparison across studies.

Assessing barriers to diabetes medication adherence using the Information-Motivation-Behavioral skills model.

AIMS: Medication nonadherence is a prevalent and costly problem among patients with type 2 diabetes. Applications of theory can inform and improve adherence promotion interventions. We used a new assessment based on the Information-Motivation-Behavioral skills (IMB) model of adherence to assess patient-reported barriers and test the theoretical model. METHODS: Participants (N = 237) completed a card sorting task to identify barriers to adherence, a survey, and a hemoglobin A1c (HbA1c) test. We identified the most commonly reported adherence barriers and examined associations between patient characteristics and barriers mapped onto each of the IMB constructs. We used structural equation modeling to test the IMB model and determine if barriers as reported on this measure predict patients' self-reported diabetes medication adherence and, in turn, HbA1c levels. RESULTS: The most frequently reported barriers were forgetting doses, thinking brand name medicine works better than generic medicine, not seeing immediate benefit, and feeling burned out with taking diabetes medicine. Younger age and lower health literacy were associated with higher barrier scores for all IMB model constructs. Information and social motivation barriers affected adherence via behavioral skills barriers (indirect effects -0.19, CI [-0.33, -0.09] and -0.24, CI [-0.37, -0.14], respectively). The IMB barrier constructs explained 44% of the variance in diabetes medication adherence which, in turn, was significantly associated with and explained 8% of the variance in HbA1c (both p < .001). CONCLUSIONS: Results suggest this assessment task can identify patient-specific barriers to diabetes medication adherence. Interventions targeting patient-specific barriers using this assessment could improve adherence and HbA1c.