Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM

Clinical Trial ID: NCT04203147

Description

The objective of this protocol is to evaluate the efficacy and cost-effectiveness of 8 sessions of in-home, group-based, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) delivered by trained diabetes nurse educators among low income, ethnic minority seniors with poorly controlled T2DM, living in independent senior housing in Milwaukee using a cluster-randomized design. The aims of this cluster-randomized efficacy trial are: Aim 1: To test the efficacy of Home DM-BAT on clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol). Hypothesis 1: Low income, minority seniors with poorly controlled T2DM randomized to Home DM-BAT will have significantly greater improvements in clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol) at 12 months of follow-up compared to the control group (in-home, group-based supportive therapy - ST). Aim 2: To test the efficacy of Home DM-BAT on behavioral outcomes (home blood glucose monitoring, diet, exercise and medication adherence) and quality of life. Hypothesis 2: Low income, minority seniors with poorly controlled T2DM randomized to Home DM-BAT will have significantly greater improvements in behavioral outcomes (home blood glucose monitoring, diet, exercise and medication adherence) and quality of life (physical and mental health components of SF-12) at 12 months of follow-up compared to the control group. Aim 3: To determine the cost-effectiveness of Home DM-BAT intervention for diabetes. Hypothesis 3: Home DM-BAT will be more cost-effective in improving hemoglobin A1c levels at 12 months of follow-up, compared to the control group, as measured by differences in program costs, resource utilization, and hemoglobin A1c levels. Exploratory Analyses: Investigators will evaluate the impact of key social determinants of health (e.g. food insecurity, housing insecurity, competing needs, stress/coping etc.) on clinical, behavioral and quality of life outcomes and their roles as potential mediators or moderators of treatment efficacy.

Study Overview. This study will evaluate the efficacy and cost-effectiveness of 8 sessions of in-home, group-based, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) delivered by trained diabetes nurse educators among low income, ethnic minority seniors (age ?65 years of age) with poorly controlled T2DM (HbA1c ?8%), living in independent senior housing in Milwaukee using a cluster-randomized design. Thirty (30) senior housing sites will be randomized to Home DM-BAT (n=15) or the control condition (in-home, group-based supportive therapy -ST) (n=15) to control for attention. Each senior housing site (cluster) will have a group of 10 seniors each for a total sample size of 300 seniors (150 in intervention and 150 in control groups). The intervention includes 8 weekly intervention sessions and 10 monthly booster sessions. The group sessions will last two (2) hours. Study assessments will be performed by blinded research assistants at baseline, 3-, 6-, 9-, and 12-months of follow-up. Primary analyses will be conducted at 12 months post-randomization. Aim 1 will test the efficacy of Home DM-BAT on clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol). Aim 2 will test the efficacy of Home DM-BAT on behavioral outcomes (home blood glucose monitoring, diet, exercise and medication adherence) and quality of life. Aim 3 will determine the cost-effectiveness of Home DM-BAT intervention for diabetes. This study will apply strict principles of randomized clinical trials including randomization, blinding, careful tracking of all participants and intent-to-treat analyses to ensure robust and unbiased results. In addition, the study will be registered in clinicaltrials.gov and deidentified individual-patient data underlying the results of the study will be housed in a depository that will be made available to other researchers within 6 months of study completion to ensure reproducibility. Patient Randomization: A permuted block randomization method will be used to assign subjects to one of the two intervention groups: (a) Home DM-BAT intervention; and (b) Control (GHE/ST). Block size will be varied to minimize the likelihood that the blind will be broken. The randomization will be stratified by senior housing type (independent senior housing, senior centers, and subsidized senior housing centers) and baseline HbA1c levels (8-10% vs. >10%). Using REDCap, RAs will collect eligibility information and enter the information into the study database via the secured study website. Once eligibility is confirmed, the computer will generate the intervention assignment based on the pre-programmed randomization scheme. All subjects who are randomized will be entered into the study database and analyzed according to CONSORT guidelines (Altman 2001). Avoiding Contamination: There are two strategies to avoid contamination. The first strategy is the cluster randomized design, which ensures that participants from the same senior housing site are randomized to the same intervention. The second strategy is to use the same nurse educator to deliver the Home DM-BAT intervention to active intervention sites and the same nurse educator to deliver the GHE/ST intervention to the control sites. The investigators have used this approach successfully in a prior RCT (R01DK081121, PI: Egede). Description of the Home DM-BAT Intervention: A trained nurse educator will deliver the manualized Home DM-BAT intervention in a group setting. Subjects will receive 8?weekly sessions of behavioral activation and monthly booster sessions from months 3-12. Home DM-BAT is extremely suitable to standard diabetes management approaches because it targets important diabetes management behaviors (medication taking, physical activity, health eating, and self-monitoring of glucose and BP). Moreover, Home DM-BAT specifically attempts to incorporate contingencies of environmental reinforcement for positive health behaviors, with a focus on medication adherence and other diabetes specific healthy behaviors including physical activity, healthy eating, abstinence from smoking, and involvement in pleasurable activities that the patient chooses, such as spending time with friends, spirituality, or volunteer work. These supplemental activities are directed at improving overall emotional well-being. All intervention sessions will be held at the senior sites on a Saturday morning that does not interfere with previously scheduled activities. Each group session will last 120 minutes and will include 30 minutes for opening/icebreaker and group interaction, 30 minutes for a previously tested diabetes education/skills training intervention based on ADA guidelines, 30 minutes for diabetes-tailored behavioral activation, and 30 minutes to address social determinant of health issues, provide support, accountability and closing. The investigators have piloted the Home DM-BAT intervention as noted in the preliminary studies section. Control Group (GHE+ST): Patients randomized to the control group will receive group-based in-home 8?weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12. Given that this is an effectiveness trial, the control group was designed to match the intervention group for both content and attention. The GHE component matches the diabetes education component of Home DM-BAT and ST component matches the behavioral activation component of Home DM-BAT. In addition, delivering GHE/ST to the control group will reduce attrition, maintain blinding, and maintain community trust. The control group will not receive diabetes education, address social determinants of health, or behavioral activation. The investigators have used the GHE+ST modules successfully in prior RCTs.


Criteria

Inclusion Criteria: 1. Age >=65 years of age; 2. Self-identified as Black/African American or Hispanic; 3. Clinical diagnosis of T2DM verified by an HbA1c >=8% at the screening assessment; 5) Able to communicate in English or Spanish; and 6) Resident of independent or subsidized senior housing facility in Milwaukee County. Exclusion Criteria: 1. Mental confusion at screening assessment suggesting significant dementia; 2. Participation in other diabetes research; 3. Alcohol or drug abuse/dependency; 4. Active psychosis or acute mental disorder; and 5. Life expectancy <12 months at screening assessment based on medical history and comorbidity screen used in prior studies.

  • Start Date

    2020-01-03

  • Last Updated

    2020-01-27

  • Sponsor

    Medical College of Wisconsin

  • Condition Name

    Type 2 Diabetes

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