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Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT.

ABSTRACT: INTRODUCTION:This randomized controlled trial investigated community-clinical intervention strategies for a Mexican American population who had not demonstrated control of their diabetes. We tested a control program (Salud y Vida 1.0) supporting diabetes management versus an enhanced version (Salud y Vida 2.0) for reductions in HbA1c at 12 months. RESEARCH DESIGN AND METHODS:Adults with uncontrolled diabetes (n=353) were enrolled if they had an HbA1c?9.0% during a program or doctor's visit between 6 and 36 months of their receipt of SyV 1.0 services, were patients at one of two clinics in local counties, and had an HbA1c?8.0% at SyV 2.0 baseline enrollment. The control and intervention arms were coordinated by community health workers and the intervention arm included the control program enhanced with medication therapy management; behavioral health services; peer-led support groups; and additional community-based lifestyle programs also open to the family. RESULTS:At 12 months, both study arms improved HbA1c (mean, (CI), Control (-0.47 (-0.74 to -0.20)) and intervention (-0.48 (-0.76 to -0.19)). The intervention group maintained HbA1c levels after month 6, whereas control group HbA1c levels slightly increased (adjusted mean from 9.83%?at month 6%-9.90%?at month 12). Also, HbA1c was examined by level of participant engagement. The high engagement group showed a decreasing trend over the study period, while control and lower engagement groups failed to maintain HbA1c levels at month 12. CONCLUSIONS:Improved HbA1c was found among a population that had not demonstrated diabetes management prior; however, mean HbA1c values were above clinical guideline recommendations. The randomized control trial findings provide additional evidence that extended time and intervention supports may be needed for populations experiencing inequities in social determinants of health. TRIAL REGISTRATION NUMBER:NCT04035395.

SUBMITTER: Reininger BM

PROVIDER: S-EPMC7264997 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT.

Reininger Belinda M BM Lee MinJae M Hessabi Manouchehr M Mitchell-Bennett Lisa A LA Sifuentes Maribel R MR Guerra Jose A JA Ayala Ciara D CD Xu Tianlin T Polletta Valerie V Flynn Amy A Rahbar Mohammad H MH

BMJ open diabetes research & care 20200501 1

<h4>Introduction</h4>This randomized controlled trial investigated community-clinical intervention strategies for a Mexican American population who had not demonstrated control of their diabetes. We tested a control program (Salud y Vida 1.0) supporting diabetes management versus an enhanced version (Salud y Vida 2.0) for reductions in HbA1c at 12 months.<h4>Research design and methods</h4>Adults with uncontrolled diabetes (n=353) were enrolled if they had an HbA1c≥9.0% during a program or docto ...[more]

PMID: 32475836

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Project description:Mexican-Americans carry a high burden of type 2 diabetes and are disproportionately affected by diabetes related mortality and morbidity. Poor adherence to medication is an important barrier to achieving metabolic control and contributes to adverse health outcomes and health disparities. Little is known about barriers and facilitators to medication adherence among Mexican-Americans with diabetes. This is a qualitative study of semi-structured interviews with a sample of 27 adults (25 Mexican-Americans and 2 Latinos of other origin) with self-reported type 2 diabetes who were recruited as part of a church-based, randomized controlled trial for diabetes self-management education in a low-income, immigrant neighborhood of Chicago. Face-to-face, in-depth interviews were conducted (one in English and 26 in Spanish), audio-recorded, transcribed verbatim, and professionally translated. Systematic qualitative methods were used to analyze interviews. All 27 participants were Latino, and 25 were of Mexican descent. Participants' mean age was 57 years, 81% were female, 69% had an annual income less than $20,000 and 48% had no health insurance. Mean A1C level was 8.6% and mean systolic blood pressure was 125 mmHg. The majority of participants (85%) reported using oral diabetes medication and 35% reported taking insulin. 76% reported being affiliated with one of the two partnering catholic churches based in the South Lawndale neighborhood of Chicago, also known as Little Village. Concerns regarding effectiveness and negative impact of diabetes medication were prevalent and expressed by 13 (48%) of 27 participants. Dissatisfaction with ineffective provider communication and not being able to pay for medication were other important barriers to adherence and were expressed by 7% and 11% of participants, respectively. Family support, for example, family members assisting in organizing medications in boxes and reminding participants to take them, was reported by 15% of participants and emerged as an important facilitator to medication adherence. There is a gap in research on factors influencing adherence to diabetes medication among Mexican-Americans. Our study suggests that concerns regarding negative impact of diabetes medication and concerns regarding effectiveness are prevalent barriers to adherence. These barriers can be addressed through educational efforts targeting patients and clinicians by specifically including content on beliefs that lead to poor adherence in diabetes self-management interventions for patients and continuing medical education for providers and by developing interventions that engage family members as a support system for medication adherence.

Project description:BackgroundHypertension (HTN) and diabetes mellitus (DM) are highly prevalent in low- and middle-income countries (LMIC) and a leading cause of morbidity and mortality. Recent evidence on effectiveness of primary care interventions has attracted renewed calls for their implementation. This review aims to synthesize evidence pertaining to primary care interventions on these two diseases, evaluated and tested in LMICs.MethodsTwo reviewers conducted an electronic search of three databases (Pubmed, EMBASE and Web of Science) and screened for eligible articles. Interventions covering health promotion, prevention, treatment, or rehabilitation activities at the PHC or community level were included.?Studies published in English, French, Portuguese and Spanish, from January 2007 to January 2017, were included. Key extraction variables included the 12 criteria identified by the Template for Intervention Description and Replication (TIDieR) checklist and guide. The Innovative Care for Chronic Conditions Framework (ICCCF) was used to guide analysis and reporting of results.Results198 articles were analyzed. The strategies focused on healthcare service organization (76.5%), community level (9.7 %), creating a positive policy environment (3.6%) and strategies covering multiple domains (10.2%). Studies included related to the following topics: description or testing of interventions (n=81; 41.3%), implementation or evaluation projects (n=42; 21.4%), quality improvement initiatives (n=15; 7.7%), screening and prevention efforts (n=26; 13.2%), management of HTN or DM (n=13; 6.6%), integrated health services (n=10; 5.1%), knowledge and attitude surveys (n=5; 2.5%), cost-effective lab tests (n=2; 1%) and policy making efforts (n=2; 1%). Most studies reported interventions by non-specialists (n=86; 43.4%) and multidisciplinary teams (n=49; 25.5%).ConclusionOnly 198 articles were found over a 10 year period which demonstrates the limited published research on highly prevalent diseases in LMIC. This review shows the variety and complexity of approaches that have been tested to address HTN and DM in LMICs and highlights the elements of interventions needed to be addressed in order to strengthen delivery of care. Most studies reported little information regarding implementation processes to allow replication. Given the need for multi-component complex interventions, study designs and evaluation techniques will need to be adapted by including process evaluations versus simply effectiveness or outcome evaluations.

Project description:BackgroundAfrican Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics.Research design and methodsThis randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms.ResultsAt 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (β = - 0.026, p = 0.003) and the comparison arm (β = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months.ConclusionsThe LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months.Nih trial registry numberNCT01901952.

Project description:OBJECTIVE:To systematically review and critically appraise the evidence for the effects of interventions to improve the performance of community health workers (CHWs) for community-based primary healthcare in low- and middle-income countries. DESIGN:Systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. METHODS:19 electronic databases were searched with a highly sensitive prespecified strategy and the grey literature examined, completed July 2016. Randomised controlled trials evaluating interventions to improve CHW performance in low- and middle-income countries were included and appraised for risk of bias. Outcomes were biological and behavioural patient outcomes (primary), use of health services, quality of care provided by CHWs and CHW retention (secondary). RESULTS:Two reviewers screened 8082 records; 14 evaluations were included. Due to heterogeneity and lack of clear outcome data, no meta-analysis was conducted. Results were presented in a narrative summary. The review found one study showing no effect on the biological outcomes of interest, though these moderate quality data may not be indicative of all biological outcomes. It also found moderate quality evidence of the efficacy of performance improvement interventions for (1) improving behavioural outcomes for patients, (2) improving use of services by increasing the absolute number of patients who access services and, perhaps, better identifying those who would benefit from such services and (3) improving CHW quality of care in terms of upstream measures like completion of prescribed activities and downstream measures like adherence to treatment protocols. Nearly half of studies were compound interventions, making it difficult to isolate the effects of individual performance improvement intervention components, though four specific strategies pertaining to recruitment, supervision, incentivisation and equipment were identified. CONCLUSIONS:Variations in recruitment, supervision, incentivisation and equipment may improve CHW performance. Practitioners should, however, assess the relevance and feasibility of these strategies in their health setting prior to implementation. Component selection experiments on a greater range of interventions to improve performance ought to be conducted.

Project description:BackgroundDiabetes is a growing concern worldwide, particularly in low- and middle-income countries (LMICs). Type 2 diabetes mellitus constitutes a significant proportion of cases and is associated with debilitating microvascular complications. Type 2 diabetes mellitus is steadily increasing among the LMICs where many barriers to health care exist. Thus, task shifting to community health workers (CHWs) has been proposed as a solution to improve diabetes management in these settings. However, CHWs often lack the necessary training to manage diabetes effectively. Thus, a systematic review is required to present evidence of the highest degree for this intervention.ObjectiveThis study aims to establish the protocols for a systemic review.MethodsUsing the Participants Intervention Comparator Outcome Time Study Design (PICOTS) framework, this study outlines a systematic review aiming to evaluate the impact of training programs for CHWs in diabetes management in LMICs. Quantitative studies focusing on CHWs, diabetes training, focusing on diabetes management outcomes like hemoglobin A1c levels and fasting blood glucose levels, between January 2000 and December 2023 and found on databases such as PubMed, Ovid MEDLINE, Evidence Based Medicine Reviews, BASE, Google Scholar, and Web of Science will be included. We will include randomized controlled trials but will also include observational studies if we find less than 5 randomized controlled trials. An author committee consisting of 3 reviewers will be formed, where 2 reviewers will conduct the review independently while the third will resolve all disputes. The Cochrane Methods Risk of Bias Tool 2 will be used for assessing the risk of bias and the Grading of Recommendations, Assessment, Development and Evaluation approach for the meta-analysis and narrative synthesis analysis will be used. The results will be presented in a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram.ResultsThe review will begin in May 2024 and conclude in 3 months.ConclusionsThe review will synthesize existing evidence and provide insights into the effectiveness of such programs, informing future research and practice in diabetes care in LMICs.Trial registrationPROSPERO CRD42022341717; https://tinyurl.com/jva2hpdr.International registered report identifier (irrid)PRR1-10.2196/57313.

Project description:Mexican Americans have a high prevalence of diabetes and burden of diabetes-related complications, highlighting the need for novel preventive strategies and noninvasive predictors of diabetes risk tailored to this population. Changes in the gut microbiome have the potential to predict diabetes. Here, we aimed to identify alterations in the gut microbiome associated with diabetes in the high-risk population of Mexican Americans in South Texas. Stool samples were collected from 216 subjects from the population-based Cameron County Hispanic Cohort. Among them, 75 had type 2 diabetes. Taxonomic and functional profiling of the stool samples were assessed by 16S and shotgun metagenomic sequencing, and the influence of genetic factors was explored. The gut microbiome of subjects with diabetes was enriched with proinflammatory Proteobacteria members (Enterobacteriaceae, Escherichia-Shigella) and depleted of butyrate-producing Clostridiales members (Faecalibacterium prausnitzii, Peptostreptococcaceae, and Clostridium sensu stricto 1). The accompanying metagenomic changes in subjects with diabetes suggested dysregulated amino acid metabolism, reduced galacturonate and glucuronate catabolism (correlating with Faecalibacterium prausnitzii abundance), and enriched heme biosynthesis (correlating with Enterobacteriaceae abundance). Polymorphism rs7129790 near MMP27 was strongly associated with high Proteobacteria abundance and was more frequent in this cohort and in individuals of Mexican ancestry than in Europeans. In conclusion, Mexican Americans in South Texas with diabetes display distinct gut microbiome and metagenomic signatures. These signatures may have utility in risk modeling and disease prevention in this high-risk population. IMPORTANCE The gut microbiome composition varies across ethnicities and geographical locations, yet studies on diabetes-associated microbiome changes specific to high-risk Mexican Americans are lacking. Here, we aimed to identify specific alterations associated with diabetes in this population, as well as host genetic factors that may explain increased disease susceptibility in this ethnic group. Using samples from a population-based cohort of Mexican Americans with a high prevalence of obesity and diabetes, we confirmed findings from studies on other ethnicities that suggested promotion of a chronic proinflammatory environment, loss of butyrate production, and compromised intestinal barrier integrity. High abundance of proinflammatory Proteobacteria was associated with a polymorphism that was more frequent in this cohort and in individuals of Mexican ancestry than in Europeans. Validation of microbiome-based risk models for diabetes should be evaluated in prospective cohort studies.

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Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT.

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Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT.

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