HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with type 2 diabetes—study protocol for a randomized controlled trial
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SUBMITTER: Egede L
PROVIDER: S-EPMC8574935 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: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.
| S-EPMC3219699 | biostudies-literature
Project description:BACKGROUND:Control of hypertension in low- and middle-income countries (LMICs) is poor, often less than 10%. A strong body of evidence demonstrates that home blood pressure management lowers blood pressure, and recent guidelines from the National Institute for Clinical Health and Excellence recommends home blood pressure monitoring. However, the preponderance of data on the benefits of home blood pressure management comes from studies in high-income countries. OBJECTIVE:The objective of the study is to examine whether an intervention of home blood pressure management is feasible in LMICs. Home blood pressure management is defined as self-monitoring of blood pressure and self-titration of antihypertensive medications. We will identify barriers and facilitators of home blood pressure management and explore unique contextual factors in LMICs that influence implementation of home blood pressure management. METHODS:Participants will be recruited from 6 sites from 2015 to 2018. Patients and health care workers will be included. We will use mixed methods including focus groups, interviews, and standardized checklists. When possible, we will adapt materials from prior successful studies so that they are culturally and contextually appropriate. RESULTS:This ongoing study is funded by the World Heart Federation. The information that is obtained will be used to develop a randomized clinical trial of home blood pressure management in LMICs. CONCLUSIONS:The data generated from this qualitative study will provide much needed information from patients and health care workers about barriers and facilitators of home blood pressure management and unique contextual factors that might influence implementation of home blood pressure management in LMICs.
| S-EPMC5662792 | biostudies-literature
Project description:BACKGROUND:The Institute for International Internet Interventions for Health at Palo Alto University proposes to develop digital tools specifically to help low-income English- and Spanish-speaking smokers to quit. Individuals from lower-income countries and those with lower social status quit at lower rates than those from high-income countries and those with higher social status. OBJECTIVE:We plan to launch a project designed to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public-sector health care system can significantly improve its acceptability, utilization, and effectiveness. METHODS:Using human-centered development methods, we will involve low-income patients in the design of a Web app/text messaging tool. We will also use their input to improve our recruitment and dissemination strategies. We will iteratively develop versions of the digital interventions informed by our human-centered approach. The project involves three specific aims: (1) human-centered development of an English/Spanish smoking cessation web app, (2) improvement of dissemination strategies, and (3) evaluation of resulting smoking cessation web app. We will develop iterative versions of a digital smoking cessation tool that is highly responsive to the needs and preferences of the users. Input from participants will identify effective ways of reaching and encouraging low-income English- and Spanish-speaking smokers to use the digital smoking cessation interventions to be developed. This information will support ongoing dissemination and implementation efforts beyond the grant period. We will evaluate the effectiveness of the successive versions of the resulting stop smoking Web app by an online randomized controlled trial. Increased effectiveness will be defined as increased utilization of the Web app and higher abstinence rates than those obtained by a baseline usual care Web app. RESULTS:Recruitment will begin January 2016, the study is intended to be completed by summer 2018, and the results should be available by fall 2019. CONCLUSIONS:This study will provide useful knowledge in developing, testing, and disseminating mobile-based interventions for low-income smokers. CLINICALTRIAL:ClinicalTrials.gov NCT02666482; https://clinicaltrials.gov/ct2/show/NCT02666482 (Archived by WebCite at http://www.webcitation.org/6gtcwaT28).
| S-EPMC4925932 | biostudies-literature
Project description:Despite the many antihypertensive medications available, two-thirds of patients with hypertension do not achieve blood pressure control. This is thought to be due to a combination of poor patient education, poor medication adherence, and "clinical inertia." The present trial evaluates an intervention consisting of health coaching, home blood pressure monitoring, and home medication titration as a method to address these three causes of poor hypertension control.The randomized controlled trial will include 300 patients with poorly controlled hypertension. Participants will be recruited from a primary care clinic in a teaching hospital that primarily serves low-income populations.An intervention group of 150 participants will receive health coaching, home blood pressure monitoring, and home-titration of antihypertensive medications during 6 months. The control group (n=150) will receive health coaching plus home blood pressure monitoring for the same duration. A passive control group will receive usual care. Blood pressure measurements will take place at baseline, and after 6 and 12 months. The primary outcome will be change in systolic blood pressure after 6 and 12 months. Secondary outcomes measured will be change in diastolic blood pressure, adverse events, and patient and provider satisfaction.The present study is designed to assess whether the 3-pronged approach of health coaching, home blood pressure monitoring, and home medication titration can successfully improve blood pressure, and if so, whether this effect persists beyond the period of the intervention.ClinicalTrials.gov identifier: NCT01013857.
| S-EPMC2797520 | biostudies-literature
Project description:IntroductionGiven the burden of diabetes in ethnic minorities and emerging data on the efficacy of financial incentives in type 2 diabetes mellitus (T2DM), it is critical to examine the efficacy of financial incentives across and within racial/ethnic groups.Methods and analysisThis trial is an ongoing 5-year, randomised clinical trial designed to test the efficacy of a Financial Incentives And Nurse Coaching to Enhance Diabetes Outcomes (FINANCE-DM) intervention composed of (1) nurse education, (2) home telemonitoring and (3) structured financial incentives; compared with an active control group (nurse education and home telemonitoring alone). The study also will evaluate whether intervention effects are sustained 6 months after the financial incentives are withdrawn (ie, 18 months post-randomisation) and whether the intervention is differentially efficacious across racial/ethnic groups. Participants will include 450 adults with a clinical diagnosis of T2DM and HbA1c of 8% or higher who self-identify as White, African American or Hispanic. Participants will be randomised to one of two groups: the FINANCE intervention or Active Control. The location and setting of this study include primary care clinics at the Medical College of Wisconsin (MCW) in Milwaukee, WI and community partner sites affiliated with the Center for Advancing Population Science at MCW.Ethics and disseminationThis trial was approved by IRB at MCW under PRO00033788.Trial registration numberRegistration for this trial on the United States National Institute of Health Clinical Trials Registry can be found under ID: NCT04203173 and online (https://clinicaltrials.gov/ct2/show/NCT04203173?id=NCT04203173&draw=2&rank=1).
| S-EPMC7757449 | biostudies-literature
Project description:Research on older children and high-resource families demonstrates that maternal improvement in depression often leads to parallel changes in parenting and child adjustment. It is unclear if this association extends to younger children and low-income mothers. This study examined if In-Home Cognitive Behavioral Therapy (IH-CBT), a treatment for depressed mothers participating in home visiting programs, contributes to improvements in parenting and child adjustment. Ninety-three depressed mothers in home visiting between 2 and 10 months postpartum were randomly assigned to IH-CBT (n = 47) plus home visiting or standard home visiting (SHV; n = 46). Mothers were identified via screening and subsequent diagnosis of major depressive disorder (MDD). Measures of depression, parenting stress, nurturing parenting, and child adjustment were administered at pre-treatment, post-treatment, and 3 months follow-up. Results indicated that there were no differences between IH-CBT and controls on parenting and child adjustment. Low levels of depression were associated with decreased parenting stress and increased nurturing parenting. Improvement in depression was related to changes in parenting in low-income mothers participating in home visiting programs. IH-CBT was not independently associated with these improvements, although to the extent that treatment facilitated improvement; there were corresponding benefits to parenting. Child adjustment was not associated with maternal depression, a finding possibly attributed to the benefits of concurrent home visiting or measurement limitations. Future research should focus on longer-term follow-up, implications of relapse, and child adjustment in later years.
| S-EPMC4420724 | biostudies-literature
Project description:ObjectiveTo estimate the impact of a soft cap (a ceiling on utilization beyond which insured enrollees pay a higher copayment) on low-income elders' use of prescription drugs.Data sources and settingClaims and enrollment files for the first year ( June 2002 through May 2003) of the Illinois SeniorCare program, a state pharmacy assistance program, and Medicare claims and enrollment files, 2001 through 2003. SeniorCare enrolled non-Medicaid-eligible elders with income less than 200 percent of Federal Poverty Level. Minimal copays increased by 20 percent of prescription cost when enrollee expenditures reached $1,750.Research designModels were estimated for three dependent variables: enrollees' average monthly utilization (number of prescriptions), spending, and the proportion of drugs that were generic rather than brand. Observations included all program enrollees who exceeded the cap and covered two periods, before and after the cap was exceeded.Principle findingsOn average, enrollees exceeding the cap reduced the number of drugs they purchased by 14 percent, monthly expenditures decreased by 19 percent, and the proportion generic increased by 4 percent, all significant at p<.01. Impacts were greater for enrollees with greater initial spending, for enrollees without one of five chronic illness diagnoses in the previous calendar year, and for enrollees with lower income.ConclusionsNear-poor elders enrolled in plans with caps or coverage gaps, including Part D plans, may face sharp declines in utilization when they exceed these thresholds.
| S-EPMC2699919 | biostudies-literature
Project description:BackgroundThe Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS) was a 2 x 2 factorial randomized trial that tested the impact of a tailored self-management education support (SMES) program, which demonstrated a 22% reduction in adverse clinical events. We sought to qualitatively explore participants' perspectives on the SMES intervention, and the ways in which it may have improved self-management skills.MethodsWe used a qualitative descriptive approach and conducted individual semistructured interviews. We conducted inductive and deductive thematic analysis using NVivo 12 (QSR International, Burlington, MA).ResultsWe interviewed 20 participants who had recently completed the 3-year SMES intervention. The following 3 main themes emerged from the data: (i) empowerment; (ii) intervention acceptability; and (iii) suggestions for improvement. Regarding empowerment, we identified subthemes of health literacy, self-efficacy, self-management, and active role in health. Several participants reported that empowerment promoted health behaviour change or improved confidence in self-management. Regarding acceptability, we identified subthemes of ease of use and presentation style. Most participants expressed positive feelings toward the intervention and felt that it was easy to understand. Finally, we identified subthemes of learning style, content, and engagement strategies, within the theme of suggestions for improvement. Some participants said that the messages were too general and did not fully address the complex health concerns they had.ConclusionsOur results highlighted key strategies to promote patient engagement and self-management behaviours and demonstrated how they may have been used to improve clinical endpoints. Additionally, we demonstrated the novel use of marketing principles in SMES interventions.
| S-EPMC10679452 | biostudies-literature
Project description:IntroductionThe diabetes mellitus (DM) epidemic is a major public health concern globally, with the highest-burden in low-income and middle-income countries (LMICs). Diabetic retinopathy (DR) is a microvascular complication of diabetes, and if left untreated can lead to visual impairment and blindness. Epidemiological studies suggest that the incidence of sight-threatening DR is decreasing in high-income countries due to improved treatments and management of DM; however, these trends are not replicated in LMICs. In this paper, we outline a scoping review protocol that aims to identify which LMICs have included DR in their national DM, non-communicable disease or prevention of blindness plans. The scoping review also aims to assess gaps when implementing national DR screening programmes in LMICs.Methods and analysisThis scoping review will follow the Arksey and O'Malley (2005) methodology and the Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Review guidelines. A comprehensive search of peer-reviewed and grey literature will be conducted from October 1989 (St. Vincent Declaration) to February 2020. Studies will be identified from electronic databases; Medline, Embase and CENTRAL (Cochrane Library). To identify further relevant articles, a hand search will be conducted using the reference lists of included studies. Two reviewers will independently screen records for relevant data and disagreements about eligibility will be resolved through consensus or arbitration by a third reviewer. A quantitative analysis will be performed to highlight key findings and thematic analysis will be used to identify emerging themes and subthemes from included studies. The key themes will highlight countries progress in terms of national-level DR service planning and screening implementation.Ethics and disseminationNo ethical approval is required because the scoping review methodology aims to synthesise information from publicly available resources. The results will be disseminated through conference presentations and peer-reviewed publication.
| S-EPMC7511640 | biostudies-literature
Project description:INTRODUCTION:Oral anticoagulants (OACs) are widely prescribed in older adults. High OAC-related adverse event rates in the early period following hospital discharge argue for an analysis to identify predictors. Our objective is to identify and validate clinical and continuity of care variables among seniors discharged from hospital on an OAC, which are independently associated with OAC-related adverse events within 30 days. METHODS AND ANALYSIS:We propose a population-based retrospective cohort study of all adults aged 66 years or older who were discharged from hospital on an OAC from September 2010 to March 2015 in Ontario, Canada. The primary outcome is a composite of the first hospitalisation or emergency department visit for a haemorrhage or thromboembolic event or mortality within 30 days of hospital discharge. A Cox proportional hazards model will be used to determine the association between the composite outcome and a set of prespecified covariates. A split sample method will be adopted to validate the variables associated with OAC-related adverse events. ETHICS AND DISSEMINATION:The use of data in this project was authorised under section 45 of Ontario's Personal Health Information Protection Act, which does not require review by a research ethics board. Results will be disseminated via peer-reviewed publications and presentations at conferences and will determine intervention targets to improve OAC management in upcoming randomised trials. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT02777047; Pre-results.
| S-EPMC7509956 | biostudies-literature