| Sumario: | BACKGROUND: The effects of medication nonadherence are especially profound in remote, economically depressed communities with a high burden of chronic diseases, such as the rural Alabama Black Belt region. We built on our previous work in this region to rigorously test a community member-delivered intervention designed in partnership with community peer coaches. SPECIFIC AIMS: With our community partners, using qualitative research methods, we developed a medication adherence intervention delivered by trained community members (aim 1) and then tested this intervention in a cluster-randomized trial of individuals with diabetes seeking help with adherence to their medications (aim 2). METHODS: We first conducted qualitative research with experienced peer coaches and community members to learn their perspectives on diabetes and the medications used to treat it. Using this information, the Corbin and Strauss framework of the lived experience of illness, Bandura's social cognitive theory, and adult learning theory, we developed an 11-session telephone-delivered diabetes self-management intervention that stressed medication adherence, assessed barriers to adherence, and involved strategizing to overcome these barriers. The intervention, delivered by community peer coaches, also provided information on healthy eating, physical activity, and stress reduction, and encouraged communication with health care providers. We then conducted a cluster-randomized trial, using towns as clusters, to test the effectiveness of this intervention. The intervention was deployed by trained peer coaches who resided in the same communities as the participants. We collected baseline and 6-month follow-up data in the communities where participants were recruited. The primary outcomes were self-reported medication adherence and measures of hemoglobin A1c, blood pressure, low-density lipoprotein cholesterol, and body mass index. Secondary outcomes were quality of life (QOL), medication beliefs, and self-efficacy to use medications. RESULTS: We recruited a total of 473 participants, 403 of whom completed follow-up (85.4% retention), which was within the design specifications for the study. The mean age of the trial population was 57.2 years, 78.2% were women, 90.6% were African American, 69.3% reported an annual income of < 20 000, 26.7% were employed, and 43.8% were taking insulin. In the control arm, 239 (89%) participants completed the study, and in the intervention arm, 164 (81%) completed the study. The intervention dose was high, with 81.8% of intervention participants completing all 11 sessions of the program. Self-reported medication adherence improved more in the intervention arm than in the control arm (P < .0001), but the other primary outcomes did not differ significantly between the trial arms. QOL improved similarly across both trial arms, but beliefs about the need for medications, concerns about medications, and medication use self-efficacy improved more in intervention than in control participants. Satisfaction with the program was high. CONCLUSIONS: This intervention was highly engaging and improved self-reported medication adherence and self-efficacy, but it did not improve glycemic control or other physiologic parameters among mostly African American individuals desiring help with their diabetes medications and living in a remote, economically disadvantaged rural region. LIMITATIONS: Real-world challenges created delays in data collection, which may have influenced the study results. The self-reported availability of healthy foods was limited, possibly limiting dietary changes recommended in the intervention, such as increasing the consumption of fresh fruits and vegetables. The intervention was entirely community based and without a clinical component; thus, medication titration to achieve better glycemic control was not included as part of the intervention and may have limited the intervention's impact on physiologic parameters. The fact that the study was restricted to the Black Belt setting may limit the generalizability of the findings.
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