Dataset Information

Protocol for a Pilot Randomized Controlled Mixed Methods Feasibility Trial of a Culturally Adapted Peer Support and Self-Management Intervention for African Americans.

ABSTRACT:

Background

Due to diabetes disparities commonly seen among African Americans, it is important to address psychosocial and sociocultural barriers to medication adherence among African Americans with diabetes. Building on our prior work testing a culturally adapted peer supported diabetes self-management intervention for African Americans, this study will conduct a pilot randomized controlled feasibility trial that compares the culturally adapted intervention with a standard diabetes self-management program.

Methods

Using an intervention mixed-methods design, the six-month trial will be conducted at two sites. Twenty-four African Americans with uncontrolled type 2 diabetes will be randomized to the intervention or control arm. Feasibility and acceptability outcomes in four domains (recruitment, intervention acceptability, intervention adherence, retention) will be collected. Primary clinical outcome (A1C), secondary outcome (medication adherence) and patient-specific psychosocial measures will be collected at baseline, 2 months, and 6 months. Document review, interview and focus groups will be used to gather qualitative data on feasibility and acceptability.

Results

Expected results are that the trial protocol will be feasible to implement and acceptable for participants, and there will be a signal of clinically meaningful reduction in A1C and improvements in medication adherence.

Conclusions

The results of this trial will inform a future powered large-scale randomized controlled trial testing the effectiveness of the culturally tailored intervention.

SUBMITTER: Shiyanbola OO

PROVIDER: S-EPMC9844478 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Protocol for a Pilot Randomized Controlled Mixed Methods Feasibility Trial of a Culturally Adapted Peer Support and Self-Management Intervention for African Americans.

Shiyanbola Olayinka O OO Maurer Martha M Wen Meng-Jung MJ

Pharmacy (Basel, Switzerland) 20221221 1

<h4>Background</h4>Due to diabetes disparities commonly seen among African Americans, it is important to address psychosocial and sociocultural barriers to medication adherence among African Americans with diabetes. Building on our prior work testing a culturally adapted peer supported diabetes self-management intervention for African Americans, this study will conduct a pilot randomized controlled feasibility trial that compares the culturally adapted intervention with a standard diabetes self- ...[more]

PMID: 36649012

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Project description:IntroductionCurrent diabetes self-management programs are often insufficient to improve outcomes for African Americans because of a limited focus on medication adherence and addressing culturally influenced beliefs about diabetes and medicines. This study evaluated the feasibility and acceptability of a novel culturally tailored diabetes self-management intervention that addressed key psychosocial and sociocultural barriers to medication adherence for African Americans.MethodsThe intervention consisted of group education and race-congruent peer-based phone support. Three African Americans who were engaged in taking their diabetes medicines (ambassadors), were matched with 8 African Americans who were not engaged in taking medicines (buddies). We conducted a single group, pre/post study design with African Americans with type 2 diabetes. Wilcoxon signed rank tests assessed mean score differences in outcomes at baseline compared with 6-months follow-up. Semi-structured interviews explored buddies' acceptability of the intervention.ResultsBuddies and ambassadors were similar in age and mostly female. Recruitment rates were 80% for buddies and 100% for ambassadors. Retention rate for primary outcomes was 75%. Buddies had a mean completion of 13.4/17 of sessions and phone calls. Ambassadors completed 84% of intervention calls with buddies. Although there were no statistically significant differences in mean A1C and medication adherence, we found a clinically meaningful decrease (-0.7) in mean A1C at the 6-month follow up compared to baseline. Secondary outcomes showed signal of changes. Themes showed buddies perceived an improvement in provider communication, learned goal setting strategies, and developed motivation, and confidence for self-management. Buddies perceived the program as acceptable and culturally appropriate.ConclusionThis culturally tailored diabetes self-management intervention that addresses diabetes self-management, psychosocial and behavioral barriers to medication adherence, and incorporates race-congruent peer support from African Americans engaged in taking medicines seemed feasible and acceptable. The results provide support for a fully powered randomized trial to test the intervention's efficacy.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04857411.Date of registrationApril 23, 2021.

Project description:BackgroundAfrican Americans are twice as likely to die from diabetes, compared to other racial and ethnic groups in the USA. Poor adherence to diabetes medications is common among African Americans and contributes to these disproportionally worse outcomes. A pilot study was conducted to determine the feasibility and acceptability of a peer-supported intervention targeting diabetes and medication beliefs, communication, and self-efficacy skills to enhance medication adherence among African Americans with type 2 diabetes.MethodsBased on the extended self-regulatory model and information-motivation-behavioral skills model, this intervention was piloted using a single group pre/post-intervention study design at two sites. Seventeen African Americans who self-reported as adherent to diabetes medicines (ambassadors) were paired with 22 African Americans with self-reported poor medication adherence (buddies). Feasibility outcomes evaluated recruitment, retention, and intervention adherence. Measures assessed at baseline and 1-month post-intervention included glycemic control (hemoglobin A1c), self-reported medication adherence, diabetes beliefs, concerns about diabetes medicines, and diabetes self-efficacy. Wilcoxon signed-rank tests assessed for differences in mean scores of outcome variables at baseline compared with a 3-month follow-up. Semi-structured 60-min interviews were conducted with each buddy to explore their acceptability of the intervention. To ensure the rigor of the qualitative data, we focused on analytic criteria such as credibility, confirmability, and transferability.ResultsMost buddies and ambassadors were female and about 56 years old. Feasibility outcomes included recruitment success rates of 73% for buddies and 85% for ambassadors relative to our goals. Retention rate for hemoglobin A1c and medication adherence outcome assessment was 95% for buddies. Both buddies and ambassadors had excellent intervention adherence, with buddies having a mean attendance of 7.76 out of 8 sessions/phone calls and ambassadors completing > 99% of the 105 intervention calls with Buddies. Results showed a signal of change in hemoglobin A1c (effect size = 0.14) and medication adherence (effect size = 0.35) among buddies, reduction in buddies' negative beliefs about diabetes and an increase in necessity beliefs of diabetes medicines. Summative interviews with buddies showed they valued ambassador's encouragement of self-management behaviors.ConclusionsResults support conduct of an efficacy trial to address medication adherence for African Americans with type 2 diabetes using a peer-supported tailored intervention.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04028076 .

Project description:BackgroundBlack young adults suffer from psychological distress at either similar or greater rates than that of White Americans, yet they are seven times less likely to have access to or receive effective treatments. Fortunately, mobile-health (mHealth) technology may transform mental health services and address disparities in mental healthcare. The current study utilized focus groups of Black young adults to inform the development of culturally-adapted mHealth using quantitative and qualitative approaches.MethodsThe study utilized a mixed-methods approach, in that qualitative (i.e., mini focus groups, n=11) and quantitative methods (i.e., self-report surveys) were used to explore the research questions. Participants included African American young adults (n=38, Mage =21). Participants completed self-report questionnaires prior to focus group facilitation. Correlational analyses were used to answer the quantitative research questions, and thematic analysis was used to answer the qualitative research questions.ResultsThe qualitative findings highlighted that sociocultural experiences impact mental health and treatment seeking attitudes. Despite these findings, participants highlighted a variety of desired features and content that should be incorporated into future culturally-adapted mHealth interventions. Participants also highlighted both positive and negative aspects of current mHealth technologies for mental health. Finally, the study found that on average, participants had positive attitudes towards mental health, mental health treatments, and utilizing mHealth for mental health. Participants also had strong desires for culturally-adapted mHealth interventions. Bivariate correlations also revealed significant associations between vicarious online racial discrimination and mHealth attitudes, as well as racial identity and mHealth attitudes.ConclusionsIn summary, the current study highlights that there is an urgent need for mHealth technology for mental health symptoms for African American young adults and presents a variety of features, content, and design/development considerations for future researchers.

Project description:IntroductionHealthy Beginnings is an established nurse-led early childhood obesity prevention program that promotes healthy infant feeding practices and active play in the early years of life. To improve engagement with culturally and linguistically diverse populations, the Healthy Beginnings program delivered by telephone was culturally adapted and implemented with Arabic- and Chinese-speaking mothers in Sydney, Australia. The cultural adaptation process has been published separately. In this article, we aimed to evaluate the feasibility of the culturally adapted program.MethodsIn 2018-2019, the culturally adapted Healthy Beginnings program was implemented with Arabic- and Chinese-speaking women recruited from antenatal clinics in Sydney. At four staged timepoints (from third trimester until 6 months of age), mothers were sent culturally adapted health promotion booklets and text messages and offered four support calls from bi-cultural child and family health nurses in Arabic and Chinese. A mixed methods evaluation included a) baseline and 6-month telephone surveys, followed by b) semi-structured follow-up interviews with a subset of participating mothers and program delivery staff. Main outcomes of this feasibility study were reach (recruitment and retention), intervention dose delivered (number of nurse support calls completed) and acceptability (appropriateness based on cognitive and emotional responses).ResultsAt recruitment, 176 mothers were eligible and consented to participate. Of 163 mothers who completed the baseline survey, 95% completed the program (n = 8 withdrew) and 83% completed the 6-month survey (n = 70 Arabic- and n = 65 Chinese-speaking mothers). Most mothers (n = 127, 78%) completed at least one nurse support call. The qualitative analysis of follow-up interviews with 42 mothers (22 Arabic- and 20 Chinese-speaking mothers) and 10 program delivery staff highlighted the perceived value of the program and the positive role of bi-cultural nurses and in-language resources. Mothers who completed more nurse support calls generally expressed greater acceptability.ConclusionsThe culturally adapted Healthy Beginnings program was feasible to deliver and acceptable to Arabic- and Chinese-speaking mothers. Our results highlight the importance of in-language resources and individualised bi-cultural nurse support by telephone for supporting culturally and linguistically diverse migrant families with infant feeding and active play. These findings support the potential for program refinements and progression to an effectiveness trial.

Project description:BackgroundDiabetes is burdensome to African Americans, who are twice as likely to be diagnosed, more likely to develop complications and are at a greater risk for death and disability than non-Hispanic whites. Medication adherence interventions are sometimes ineffective for African Americans because their unique illness perceptions are not adequately addressed. The Illness Perception Questionnaire-Revised (IPQ-R) that assesses illness perceptions has shown reliability and validity problems when used with African Americans. Thus, the study objective was to adapt the IPQ-R for African Americans and assess the validity and reliability of the culturally adapted questionnaire.MethodsThe parent study used an exploratory sequential mixed methods design, to explore African Americans' illness perceptions qualitatively, used the results to adapt the IPQ-R, and tested the culturally adapted IPQ-R items quantitatively. In this paper, a preliminary culturally adapted IPQ-R refined based on the qualitative study, was administered to 170 middle-aged United States-based African Americans with type 2 diabetes in a face-to-face survey. Content, construct, convergent, and predictive validity, including reliability was examined. Pearson and item-total correlations, item analysis, exploratory factor analysis, multiple linear regression analysis, and test-retest were conducted.ResultsA revised culturally adapted IPQ-R was identified with a 9-factor structure and was distinct from the old factor structure of the original IPQ-R. The 'consequences' domain from the IPQ-R occurred as two factors (external and internal consequences) while the 'emotional representations' domain in the IPQ-R emerged as separate 'present' and 'future' emotional representation factors. Illness coherence' was differently conceptualized as 'illness interpretations' to capture additional culturally adapted items within this domain. Most items had factor loadings greater than 0.4, with moderate factor score correlations. Necessity and concern beliefs in medicines significantly correlated with domains of the culturally adapted IPQ-R. Pearson's correlation values were not greater than 0.7, indicating good convergent validity. The culturally adapted IPQ-R significantly predicted medication adherence. None of the correlation values were higher than 0.7 for the test-retest, indicating moderate reliability. Most domains of the culturally adapted IPQ-R had Cronbach's alpha values higher than 0.7, indicating good internal consistency.ConclusionsThe results provide preliminary support for the validity of the culturally adapted IPQ-R in African Americans with diabetes, showing good construct, convergent and predictive validity, as well as reliability.

Project description:BackgroundFamily-based behavioral therapy is an efficacious approach to deliver weight management counseling to children and their parents. However, most families do not have access to in-person, evidence-based treatment. We previously developed and tested DRIVE (Developing Relationships that Include Values of Eating and Exercise), a home-based parent training program to maintain body weight among children at risk for obesity, with the intent to eventually disseminate it nationally alongside SafeCare, a parent support program that focuses on parent-child interactions. Currently the DRIVE program has only been tested independently of SafeCare. This study created the "mHealth DRIVE" program by further adapting DRIVE to incorporate digital and mobile health tools, including remotely delivered sessions, a wireless scale that enabled a child-tailored weight graph, and a pedometer. Telehealth delivery via mHealth platforms and other digital tools can improve program cost-effectiveness, deliver long-term care, and directly support both families and care providers.ObjectiveThe objective of this study was to examine preliminary acceptability and effectiveness of the mHealth DRIVE program among children and parents who received it and among SafeCare providers who potentially could deliver it.MethodsStudy 1 was a 13-week pilot study of a remotely delivered mHealth family-based weight management program. Satisfaction surveys were administered, and height and weight were measured pre- and post-study. Study 2 was a feasibility/acceptability survey administered to SafeCare providers.ResultsParental and child satisfaction (mean of 4.9/6.0 and 3.8/5.0, respectively) were high, and children's (N=10) BMI z-scores significantly decreased (mean -0.14, SD 0.17; P=.025). Over 90% of SafeCare providers (N=74) indicated that SafeCare families would benefit from learning how to eat healthily and be more active, and 80% of providers reported that they and the families would benefit from digital tools to support child weight management.ConclusionsPediatric mHealth weight management interventions show promise for effectiveness and acceptability by families and providers.Trial registrationClinicaltrials.gov NCT03297541, https://clinicaltrials.gov/ct2/show/NCT03297541.

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.

Dataset Information

Protocol for a Pilot Randomized Controlled Mixed Methods Feasibility Trial of a Culturally Adapted Peer Support and Self-Management Intervention for African Americans.

Background

Methods

Results

Conclusions

Publications

Protocol for a Pilot Randomized Controlled Mixed Methods Feasibility Trial of a Culturally Adapted Peer Support and Self-Management Intervention for African Americans.

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