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

Type 2 Diabetes Clinical Trial

— HOME DM-BAT  

Official title:

HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04203147
• Other study ID #: 1R01DK118038-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Supportive Therapy (Control)
Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
• Home DM-BAT
Description: 8-weekly sessions of in-home, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12 via telephone.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

Egede LE, Davidson TM, Knapp RG, Walker RJ, Williams JS, Dismuke CE, Dawson AZ. 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. Trials. 2021 Nov 8;22(1):787. doi: 10.1186/s13063-021-05744-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality Adjusted Life Years as measured by EQ-5D	The EQ-5D is a validated measure to assess health status developed by the EuroQol group, an international team of researchers. This scale assesses health status across 5 dimensions using 26 items (Herdman 2011).	Change in baseline quality of life measure at 12 months post intervention follow-up
Other	Resource Utilization and Cost	Previously validated questions on resource utilization will be administered. The questionnaires capture information on hospitalizations, physician/professional visits, and medications.	Change in baseline baseline resource utilization and cost at 12 months post intervention follow-up
Primary	Glycemic control (HbA1c)	About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c.	Change in baseline HbA1c at 12 months post intervention follow-up
Primary	Systolic and Diastolic Blood Pressure	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.	Change in baseline blood pressure at 12 months post intervention follow-up
Primary	LDL-Cholesterol	About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.	Change in baseline cholesterol at 12 months post intervention follow-up
Secondary	Quality of Life as measured by SF-12	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.	Change in baseline quality of life measure at 12 months post intervention follow-up
Secondary	Self-Care Behaviors	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.	Change in baseline self-care behaviors at 12 months post intervention follow-up