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

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Home DM-BAT; Behavioral: Supportive Therapy (Control)

• Registration Number: NCT04203147
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

The objective of this protocol is to evaluate the efficacy and cost-effectiveness of 8 sessions of in-home, telephone-delivered, 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.

The aims of this randomized controlled 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, telephone-delivered 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.

Detailed Description

Study Overview. Two hundred participants will be randomized 1:1 to Home DM-BAT (n=100) or the control condition (n=100) to control for attention. The intervention includes 8 weekly intervention sessions and 10 monthly booster sessions. 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.

Description of the Home DM-BAT Intervention: A trained nurse educator will deliver the manualized Home DM-BAT intervention via telephone. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12. All intervention sessions will be delivered by telephone and will include a previously tested diabetes education/skills training intervention based on ADA guidelines, diabetes-tailored behavioral activation and will address social determinant of health issues.

Control Group (GHE+ST): Patients randomized to the control group will receive in-home, telephone-delivered 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 to match the intervention group for both content and attention. The control group will not receive diabetes education, address social determinants of health, or behavioral activation.

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Study Start: 2020-01-03
• Primary Completion: 2025-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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;
4. Able to communicate in English or Spanish; and
5. Resident of independent, subsidized, assisted senior housing facility or community dwelling elderly adults in the greater Milwaukee area and surrounding counties that have high African American/Hispanic populations.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home DM-BAT Intervention	Home DM-BAT	A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.
Control Group (GHE+ST)	Supportive Therapy (Control)	Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.

Primary Outcome Measures

Name	Time	Method
LDL-Cholesterol	Change in baseline cholesterol at 12 months post intervention follow-up	About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.
Glycemic control (HbA1c)	Change in baseline HbA1c at 12 months post intervention follow-up	About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c.
Systolic and Diastolic Blood Pressure	Change in baseline blood pressure at 12 months post intervention follow-up	Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-minute intervals, and give an average of the 3 BP readings.

Secondary Outcome Measures

Name	Time	Method
Quality of Life as measured by SF-12	Change in baseline quality of life measure at 12 months post intervention follow-up	The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.
Self-Care Behaviors	Change in baseline self-care behaviors at 12 months post intervention follow-up	Behavioral skills will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert 2000), a brief, validated questionnaire of diabetes self-care. Medication Adherence will be measured with the 6-item validated self-report Brooks Medication Adherence Scale (BMAS) (Brooks 1994). Each of 6 items measures a specific medication-taking behavior.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States