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:Regular participation in physical activity benefits older adults physically and mentally. However, the availability and assessment of physical activity programs that are safe and appropriate for homebound older adults at risk for nursing home admission are limited. Here we describe the protocol for a randomized controlled trial that examines the effectiveness of a gentle physical activity program. Delivered by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home, this program is implemented in a real-world context of caregiver-client dyads in a Medicaid-funded home care program. The trial uses a two-group repeated measures design (baseline, Month 4, and Month 8) with 300 pairs of eligible home care clients and their home care aides. The results from this trial could provide evidence and guidelines for a new model of home care, which would facilitate the working together of older home care clients and their home care aides to maintain or improve the functional status of nursing home-eligible older adults.
| S-EPMC8180508 | 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:BackgroundThe 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.ObjectiveWe 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.MethodsUsing 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.ResultsRecruitment will begin January 2016, the study is intended to be completed by summer 2018, and the results should be available by fall 2019.ConclusionsThis study will provide useful knowledge in developing, testing, and disseminating mobile-based interventions for low-income smokers.ClinicaltrialClinicalTrials.gov NCT02666482; https://clinicaltrials.gov/ct2/show/NCT02666482 (Archived by WebCite at http://www.webcitation.org/6gtcwaT28).
| S-EPMC4925932 | biostudies-literature
Project description:PurposeWhile the association between income and depression is well established, less explored is the relation between wealth and depression, particularly among low-income adults. We studied the relation between two types of assets-savings and home ownership-and probable depression to understand how access to different assets may shape depression among low-income US adults.MethodsStudy sample We conducted a serial cross-sectional, observational study with 12,019 adults with low-income in the United States using National Health and Nutrition Examination Survey (NHANES) data from 2007 to 2016. Measures We measured probable major depressive disorder (MDD) with impairment using the Patient Health Questionnaire-9. Low savings was defined as having $5000 or less in family savings. Statistical analysis We estimated adjusted and unadjusted prevalence, odds ratios, and predicted probability of probable MDD across asset groups.ResultsOf low-income US adults, 5.4% had probable MDD with impairment, 85.9% had low savings, and 54.9% rented their home. Persons with low savings had 2.34 (95% CI 1.44-3.79) times the odds of having probable MDD relative to those with high savings. Home owners had 2.14 (95% CI 1.20-3.86) and home renters had 3.65 (95% CI 1.45-9.20) times the odds of having probable MDD if they had low savings relative to high savings.ConclusionFamily savings and home ownership are associated with lower burden of depression among low-income adults in the US.
| S-EPMC8110606 | 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:BackgroundDespite 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.Methods/designThe 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.DiscussionThe 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.Trial registrationClinicalTrials.gov identifier: NCT01013857.
| S-EPMC2797520 | 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