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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: To test the efficacy of Home DM-BAT on glycemic control (hemoglobin A1c).
Hypothesis: Low income, minority seniors with poorly controlled T2DM randomized to Home DM-BAT will have significantly greater improvements in glycemic control (hemoglobin A1c) at 12 months of follow-up compared to the control group (in-home, telephone-delivered supportive therapy - ST).
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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home DM-BAT Intervention | Experimental | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive Therapy (Control) | Behavioral | Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control (HbA1c) | About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c. | HbA1c at 12 months post intervention follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard E Egede, MD, MS | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York at Buffalo | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34749788 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home DM-BAT Intervention | 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. 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. |
| FG001 | Control Group (GHE+ST) | 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. Supportive Therapy (Control): Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Home DM-BAT Intervention | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Control (HbA1c) | About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c. | Posted | Mean | Standard Error | mean percentage of HbA1c | HbA1c at 12 months post intervention follow-up |
|
At study completion, average of 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home DM-BAT Intervention | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | SUNY at Buffalo | 716-829-2364 | jstooks@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2021 | Feb 13, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2021 | Feb 19, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Home DM-BAT | Behavioral | 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. |
|
| BG001 | Control Group (GHE+ST) | 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. Supportive Therapy (Control): Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | mean percentage of HbA1c |
|
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.
Supportive Therapy (Control): Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Control Group (GHE+ST) | 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. Supportive Therapy (Control): Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone. | 0 | 101 | 0 | 101 | 0 | 101 |
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| D004700 | Endocrine System Diseases |