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Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

ABSTRACT: Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered diabetes education and skills training are effective at improving metabolic control in diabetes. Web-based home telemonitoring systems in conjunction with active care management are also effective ways to lower glycosylated hemoglobin A1c values when compared to standard care, and provide feedback to patients; however, there are no studies in African Americans with poorly controlled T2DM that examine the use of technology-based feedback to tailor or augment diabetes education and skills training. This study provides a unique opportunity to address this gap in the literature.We describe an ongoing 4-year randomized clinical trial, which will test the efficacy of a technology-intensified diabetes education and skills training (TIDES) intervention in African Americans with poorly controlled T2DM. Two hundred male and female AfricanAmerican participants, 21 years of age or older and with a glycosylated hemoglobin A1c level ? 8%, will be randomized into one of two groups for 12 weeks of telephone interventions: (1) TIDES intervention group or (2) a usual-care group. Participants will be followed for 12 months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that, among African Americans with poorly controlled T2DM, patients randomized to the TIDES intervention will have significantly greater reduction in glycosylated hemoglobin A1c at 12 months of follow-up compared to the usual-care group.Results from this study will add to the current literature examining how best to deliver diabetes education and skills training and provide important insight into effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in African Americans with poorly controlled T2DM.This study was registered with the National Institutes of Health Clinical Trials Registry on 13 March 2014 (ClinicalTrials.gov identifier# NCT02088658).

SUBMITTER: Williams JS

PROVIDER: S-EPMC4289359 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

Williams Joni S JS Lynch Cheryl P CP Knapp Rebecca G RG Egede Leonard E LE

Trials 20141125

<h4>Background</h4>Compared to American Whites, African Americans have a higher prevalence of type 2 diabetes mellitus (T2DM), experiencing poorer metabolic control and greater risks for complications and death. Patient-level factors, such as diabetes knowledge, self-management skills, empowerment, and perceived control, account for >90% of the variance observed in outcomes between these racial groups. There is strong evidence that self-management interventions that include telephone-delivered d ...[more]

PMID: 25425504

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Project description:BACKGROUND:African Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity. However, there are important gaps in this research, including incorporation of stakeholder perspectives (e.g. cultural appropriateness, strategies for implementation into clinical practice) and testing pain CST specifically among African Americans with OA. This study will evaluate the effectiveness of a culturally enhanced pain CST program among African Americans with OA. METHODS/DESIGN:This is a randomized controlled trial among 248 participants with symptomatic hip or knee OA, with equal allocation to a pain CST group and a wait list (WL) control group. The pain CST program incorporated feedback from patients and other stakeholders and involves 11 weekly telephone-based sessions. Outcomes are assessed at baseline, 12 weeks (primary time point), and 36 weeks (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include self-efficacy, pain coping, pain interference, quality of life, depressive symptoms, and global assessment of change. Linear mixed models will be used to compare the pain CST group to the WL control group and explore whether participant characteristics are associated with differential improvement in the pain CST program. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, Durham Veterans Affairs Medical Center, East Carolina University, and Duke University Health System. DISCUSSION:This culturally enhanced pain CST program could have a substantial impact on outcomes for African Americans with OA and may be a key strategy in the reduction of racial health disparities. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02560922 , registered 9/22/2015.

Project description:Purpose:Diabetes self-management education and support (DSME/S) is an effective strategy to improve health outcomes. However, little is known about the impact of formal DSME/S on psychological distress among minority populations. The study purposes were to 1) explore the impact of a culturally tailored DSME/S intervention on psychological distress and diabetes-related outcomes among African-American and Hispanic/Latino participants and 2) examine differences across groups in self-care, self-efficacy, diabetes knowledge, and psychological distress. Methods:Using a pre- and post-test research design, baseline and post-test assessments were conducted at weeks 1 and 7 of the intervention, respectively. Statistical analyses included descriptive statistics for demographic variables and four outcomes (self-care, self-efficacy, knowledge, and psychological distress score), general linear regression analysis of the post-test outcomes, and the Spearman correlation between psychological distress score and the outcomes. Results:Compared to African-American participants (n = 122), Hispanic/Latino participants (n = 137) were significantly younger and less educated. The two groups were comparable in sex, income, and health status. Significant pre- to post-test improvements were seen in each group for self-care, self-efficacy, and psychological distress. Diabetes knowledge had moderate improvement. Hispanics/Latinos had significantly greater post-test self-efficacy and self-care scores compared to African Americans. For both African-American and Hispanic/Latino participants, lower psychological distress scores were generally associated with greater self-efficacy and self-care. Psychological distress scores were not significantly associated with knowledge in African-Amerian or Hispanic/Latino participants. For African Americans only, better health status was significantly associated with less psychological distress. Conclusion:DSME/S programs have the potential to improve psychological health among African Americans and Hispanics/Latinos, which can lead to better diabetes outcomes.

Project description:BackgroundPeer support has been shown to improve diabetes self-management and control, but no standard exists to link peer support interventions to clinical care.ObjectiveTo compare a community-based diabetes self-management education (DSME) plus mobile health (mHealth)-enhanced peer support intervention to community-based diabetes self-management education (DSME) alone for African American adults with poorly controlled type 2 diabetes.DesignA randomized controlled trial.ParticipantsAfrican American adults, age > 19 years, receiving care within a safety-net healthcare system in Jefferson County, Alabama, with a diagnosis of type 2 diabetes and a hemoglobin A1c (A1C) ≥ 7.5%.InterventionsParticipants in the intervention group received community-based diabetes self-management education (DSME) plus 6 months of mHealth-enhanced peer support, including 12 weekly phone calls, then 3 monthly calls from community health workers, who used a novel web application to communicate with participants' healthcare teams. In the control group, participants received community-based DSME alone.Main measuresThe primary outcome was A1C; secondary outcomes included diabetes distress, depressive symptoms, self-efficacy or confidence in their ability to manage diabetes, and social support. We used mixed models repeated measures analyses to assess for between-arm differences and baseline to follow-up changes.Key resultsOf 120 participants randomized, 97 completed the study. Participants in intervention and control groups experienced clinically meaningful reduction in A1C, 10.1 (SD 1.7) to 9.6 (SD 1.9) and 9.8 (SD 1.7) to 9.1 (SD 1.9) respectively, p = 0.004. Participants in the intervention group experienced a significantly larger reduction in diabetes distress compared to the control, 2.7 (SD 1.2) to 2.1 (1.0) versus 2.6 (SD 1.1) to 2.3 (SD 1.0) p = 0.041.ConclusionsCommunity-based DSME with and without peer support led to improved glycemic control. Peer support linked to clinical care led to a larger reduction in diabetes distress, which has important implications for the overall wellbeing of adults with type 2 diabetes.

Project description:Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes.This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion.This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice.Clinicaltrials.gov NCT01070056.

Dataset Information

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

Publications

Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial.

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