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Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial.

ABSTRACT: An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for < 10% of the variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Use of telemonitoring systems offer new opportunities to support patients with T2DM while waiting to be seen by their health care providers at actual office visits. A variety of interventions testing the efficacy of telemedicine interventions have been conducted, but the outcomes have yielded equivocal results, emphasizing the shortage of controlled, randomized trials in this area. This study provides a unique opportunity to address this gap in the literature by optimizing two strategies that have been shown to improve glycemic control, while simultaneously implementing clinical outcomes measures, using a sufficient sample size, and offering health care delivery to rural, underserved and low income communities with T2DM who are seen at Federally Qualified Health Centers (FQHCs) in coastal South Carolina.We describe a four-year prospective, randomized clinical trial, which will test the effectiveness of technology-assisted case management in low income rural adults with T2DM. Two-hundred (200) male and female participants, 18 years of age or older and with an HbA1c ? 8%, will be randomized into one of two groups: (1) an intervention arm employing the innovative FORA system coupled with nurse case management or (2) a usual care group. Participants will be followed for 6-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among indigent, rural adult patients with T2DM treated in FQHC's, participants randomized to the technology-assisted case management intervention will have significantly greater reduction in HbA1c at 6 months of follow-up compared to usual care.Results from this study will provide important insight into the effectiveness of technology-assisted case management intervention (TACM) for optimizing diabetes care in indigent, rural adult patients with T2DM treated in FQHC's.National Institutes of Health Clinical Trials Registry (http://ClinicalTrials.gov identifier# NCT01373489.

SUBMITTER: Egede LE

PROVIDER: S-EPMC3219699 | biostudies-literature | 2011 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial.

Egede Leonard E LE Strom Joni L JL Fernandes Jyotika J Knapp Rebecca G RG Rojugbokan Adebola A

Trials 20111020

<h4>Background</h4>An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for < 10% of the variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Use of telemonitoring systems offe ...[more]

PMID: 22014122

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Project description:BackgroundAbout 13% of African Americans and 13% of Hispanics have diabetes, compared to 8% of non-Hispanic Whites (NHWs). This is more pronounced in the elderly where about 25-30% of those aged 65 and older have diabetes. Studies have found associations between social determinants of health (SDoH) and increased incidence, prevalence, and burden of diabetes; however, few interventions have accounted for the context in which the elderly live by addressing SDoH. Specifically, psychosocial factors (such as cognitive dysfunction, functional impairment, and social isolation) impacting this population may be under-addressed due to numerous medical concerns addressed during the clinical visit. The long-term goal of the project is to identify strategies to improve glycemic control and reduce diabetes complications and mortality in African Americans and Hispanics/Latinos with type 2 diabetes.MethodsThis is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with type 2 diabetes mellitus (T2DM) (HOME DM-BAT). Two hundred, aged 65 and older and with an HbA1c ≥8%, will be randomized into one of two groups: (1) an intervention using in-home, nurse telephone-delivered diabetes education, and behavioral activation or (2) a usual care group using in-home, nurse telephone-delivered, health education/supportive therapy. Participants will be followed for 12 months to ascertain the effect of the intervention on glycemic control, blood pressure, and low-density lipoprotein (LDL) cholesterol. The primary hypothesis is low-income, minority seniors with poorly controlled type 2 diabetes randomized to HOME DM-BAT will have significantly greater improvements in clinical outcomes at 12 months of follow-up compared to usual care.DiscussionResults from this study will provide important insight into the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with uncontrolled type 2 diabetes mellitus and inform strategies to improve glycemic control and reduce diabetes complications in minority elderly with T2DM.Trial registrationClinicalTrials.gov NCT04203147 ). Registered on December 18, 2019, with the National Institutes of Health Clinical Trials Registry.

Project description:Diabetes risk is extremely high for Latinos from low-income households. Health guidelines recommend that individuals learn strategies to self-manage their diabetes, but getting people to adopt required lifestyle changes is challenging and many people are not able to prevent their pre-diabetes from escalating or effectively control their diabetes. Systematic reviews show that culturally competent self-management programs can significantly improve diabetes outcomes and different models for culturally competent programming have been developed.This patient-engaged study will compare the effectiveness of two distinct evidence-based models for culturally competent diabetes health promotion at two sites that serve a large Latino patient population from low-income households: 1) The Diabetes Self-Management Support Empowerment Model, an educational session approach, and 2) The Chronic Care Model, a holistic community-based program. Data collection will involve interviews, focus groups, surveys and assessments of each program; and testing of patient participants for A1c, depression, Body Mass Index (BMI), and chronic stress with hair cortisol levels. We will recruit a total of 240 patient-social support pairs: Patients will be adults (men and women over the age of 18) who: 1.) Enter one of the two diabetes programs during the study; 2.) Self-identify as "Latino;" 3.) Are able to identify a social support person or key member of their social network who also agrees to participate with them; 4.) Are not pregnant (participants who become pregnant during the study will be excluded); and 5.) Have household income 250% of the Federal Poverty Level (FPL) or below. Social supports will be adults who are identified by the patient participants.Improved capacity for diabetes self-management measured through improvements in diabetes knowledge and diabetes-related patient activation.Successful diabetes self-management as measured by improvements in A1c, depression scale scores, BMI, and circulating levels of cortisol to determine chronic stress.Our hypothesis is that the program model that interfaces most synergistically with patients' culture and everyday life circumstances will have the best diabetes health outcomes.This study was registered with ClinicalTrials.gov on December 16, 2016 (Registration # NCT03004664 ).

Project description:OBJECTIVE:Community-based peer and community health worker-led diabetes self-management programs (COMP-DSMP) can benefit diabetes care, but the supporting evidence has been inadequately assessed. This systematic review explores the nature of COMP-DSMP in low- and middle-income countries' (LMIC) primary care settings and evaluates implementation strategies and diabetes-related health outcomes. METHODS:We searched the Cochrane Library, PubMed-MEDLINE, SCOPUS, CINAHL PsycINFO Database, International Clinical Trials Registry Platform, Clinicaltrials.gov, Pan African Clinical Trials Registry (PACTR), and HINARI (Health InterNetwork Access to Research Initiative) for studies that evaluated a COMP-DSMP in adults with either type 1 or type 2 diabetes in World Bank-defined LMIC from January 2000 to December 2019. Randomised and non-randomised controlled trials with at least 3 months follow-up and reporting on a behavioural, a primary psychological, and/or a clinical outcome were included. Implementation strategies were analysed using the standardised implementation framework by Proctor et al. Heterogeneity in study designs, outcomes, the scale of measurements, and measurement times precluded meta-analysis; thus, a narrative description of studies is provided. RESULTS:Of the 702 records identified, eleven studies with 6090 participants were included. COMP-DSMPs were inconsistently associated with improvements in clinical, behavioural, and psychological outcomes. Many of the included studies were evaluated as being of low quality, most had a substantial risk of bias, and there was a significant heterogeneity of the intervention characteristics (for example, peer definition, selection, recruitment, training and type, dose, and duration of delivered intervention), such that generalisation was not possible. CONCLUSIONS:The level of evidence of this systematic review was considered low according to the GRADE criteria. The existing evidence however does show some improvements in outcomes. We recommend ongoing, but well-designed studies using a framework such as the MRC framework for the development and evaluation of complex interventions to inform the evidence base on the contribution of COMP-DSMP in LMIC.

Project description:BackgroundAlthough self-management support improves diabetes outcomes, it is not consistently provided in health care settings strained for time and resources. One proposed solution to personnel and funding shortages is to utilize peer coaches, patients trained to provide diabetes education and support to other patients. Coaches share similar experiences about living with diabetes and are able to reach patients within and beyond the health care setting. Given the limited body of evidence that demonstrates peer coaching significantly improves chronic disease care, this present study examines the impact of peer coaching delivered in a primary care setting on diabetes outcomes.Methods/designThe aim of this multicenter, randomized control trial is to evaluate the effectiveness of utilizing peer coaches to improve clinical outcomes and self-management skills in low-income patients with poorly controlled diabetes. A total of 400 patients from six primary health centers based in San Francisco that serve primarily low-income populations will be randomized to receive peer coaching (n = 200) or usual care (n = 200) over 6 months. Patients in the peer coach group receive coaching from patients with diabetes who are trained and mentored as peer coaches. The primary outcome is change in HbA1c. Secondary outcomes include change in: systolic blood pressure, body mass index (BMI), LDL cholesterol, diabetes self-care activities, medication adherence, diabetes-related quality of life, diabetes self-efficacy, and depression. Clinical values (HbA1c, LDL cholesterol and blood pressure) and self-reported diabetes self-efficacy and self-care activities are measured at baseline and after 6 months for patients and coaches. Peer coaches are also assessed at 12 months.DiscussionPatients with diabetes, who are trained as peer health coaches, are uniquely poised to provide diabetes self management support and education to patients. This study is designed to investigate the impact of peer health coaching in patients with poorly controlled diabetes. Additionally, we will assess disease outcomes in patients with well controlled diabetes who are trained and work as peer health coaches.Trial registrationClinicalTrials.gov identifier: NCT01040806.

Project description:Background:Type 2 diabetes (T2D) is a worldwide epidemic and a leading cause of death in Mexico, with a prevalence of 15.9%, and >70% of diagnosed adults have poor glycemic control [glycated hemoglobin (HbA1c) >7.5%]. We developed a diabetes self-management education program contextualized to the study population, including dietary preferences, health literacy, and health system. Objectives:We aimed to evaluate the efficacy of a self-management + text message program (¡Sí, Yo Puedo Vivir Sano con Diabetes!) on primary (HbA1c), and secondary behavioral (self-management), clinical, and psychosocial outcomes in adults with T2D in Mexico City. Methods:Participants were recruited at public primary healthcare centers (Seguro Popular), and randomly allocated to treatment (n = 26) or wait-list control groups (n = 21) with data collected at 3 and 6 mo. The program included 7 weekly sessions and 6 mo of daily text/picture messages. Descriptive statistics and a generalized linear mixed model with intent-to-treat analysis were calculated. Results:Participants were 55.5 ± 8.8 y of age (mean ± SD), 68% female, 88.6% overweight/obese, and 57% lived in food-insecure households. Mean ± SD T2D duration was 11.9 ± 7.8 y and HbA1c was 9.2% ± 1.5%. There was 89% attendance at sessions and 6.4% attrition across both groups at 6 mo. Group-by-time effects were seen in self-monitoring of blood glucose (P < 0.01) and diabetes self-efficacy (P < 0.04); and a trend for lower HbA1c was seen in the intervention group at 6 mo (P = 0.11). Significant improvements in dietary behavior (P < 0.01) were demonstrated in the intervention group over time, but this did not reach statistical significance compared with the control group. Conclusions:The program was associated with clinically significant improvements in T2D self-management, self-efficacy, and HbA1c over time. Thus, T2D self-management skills, including diet, were improved in a vulnerable metropolitan population.This trial was registered at clinicaltrials.gov as NCT03159299.

Project description:IntroductionCongenital anomalies are the fifth leading cause of death in children under 5 years old globally (591 000 deaths reported in 2016). Over 95% of deaths occur in low-income and middle-income countries (LMICs). It is estimated that two-thirds of the congenital anomaly health burden could be averted through surgical intervention and that such interventions can be cost-effective. This systematic review aims to evaluate current evidence regarding the cost-effectiveness of neonatal surgery for congenital anomalies in LMICs.Methods and analysisA systematic literature review will be conducted in PubMed, MEDLINE, Embase, Cochrane Library, Scielo, Google Scholar, African Journals OnLine and Regional WHO's African Index Medicus databases for articles on the cost-effectiveness of neonatal surgery for congenital anomalies in LMICs. The following search strings will be used: (1) congenital anomalies; (2) LMICs; and (3) cost-effectiveness of surgical interventions. Articles will be uploaded to Covidence software, duplicates removed and the remaining articles screened by two independent reviewers. Cost information for interventions or procedures will be extracted by country and condition. Outcome measurements by reported unit and cost-effectiveness ratios will be extracted. Methodological quality of each article will be assessed using the Drummond checklist for economic evaluations. The Agency for Healthcare Research and Quality's Effective Health Care Program guidance will be followed to assess the grade of the studies.Ethics and disseminationNo ethical approval is required for conducting the systematic review. There will be no direct collection of data from individuals. The finalised article will be published in a scientific journal for dissemination. The protocol has been registered with PROSPERO (International Prospective Register of Systematic Reviews).ConclusionCongenital anomalies form a large component of the global health burden that is amenable to surgical intervention. This study will systematically review the current literature on the cost-effectiveness of neonatal surgery for congenital anomalies in LMICs.Prospero registration numberCRD42020172971.

Project description:INTRODUCTION:Diabetes self-management education is a key aspect in the long-term management of type 2 diabetes. The patient and healthcare professional (HCP) perspective on the use of technology-assisted DSME has yet to be studied. Hence, the objective of this study was to better understand the factors that facilitate or hinder the adoptions of such education by adults with type 2 diabetes and their HCPs. METHODS:We systematically searched five databases (Medline, Embase, CINAHL, Web of Science Core Collection, and PsycINFO) until August 2019. The search included qualitative and mixed-method studies that reported the views of patients and HCPs regarding features, uses, and implementations of technology-assisted DSME. Data were synthesized through an inductive thematic analysis. RESULTS:A total of 13 articles were included, involving 242 patients, ranging from 18 to 81 years and included web-based, mobile application, digital versatile disc (DVD), virtual reality or telehealth interventions. Patients and HCPs had mixed views towards features of the technology-assisted interventions, with patients' personal qualities and HCPs' concerns affecting uses of the interventions. Patients generally preferred technologies that were easy to access, use, and apply and that had reliable information. Patients' ambitions motivated them, and personal attributes such as poor competence with technology, poor literacy, and language barriers acted as barriers. Patients especially liked the peer support that they received but did not like it when there was no regulation of advice on these platforms. HCPs believed that while the interventions were useful to patients, they faced difficulties with integration into their clinical workflows. CONCLUSION:This review explored the features of technology-assisted diabetes self-management education interventions that enhanced positive patient engagements and the negative aspects of both the platforms and the target groups. Technical support and training will be effective in managing these concerns and ensuring meaningful use of these platforms.

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Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial.

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Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial.

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