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This study will test the preliminary efficacy of diabetes-tailored CCT (DM-CCT), which will be conditional on participating in biweekly (every two weeks), nurse-led, virtual diabetes education/skills training and stress/coping intervention compared to UCT (with no requirement for participation) on clinical outcomes, self-care behaviors, and psychological health in 100 inner city AAs with poorly controlled T2DM using an RCT design. The aims of the proposed study include:
AIM 1: Test the preliminary efficacy of the DM-CCT intervention on glycemic control and quality of life for inner-city AAs with T2DM.
AIM 2: Test the preliminary efficacy of the DM-CCT intervention on self-care behaviors and psychological health for inner-city AAs with T2DM.
AIM 3: Estimate the cost of delivery of the DM-CCT and UCT interventions in preparation for future cost effectiveness analysis.
The overarching aim of this proposal is to test the preliminary efficacy of diabetes-tailored CCT (DM-CCT conditional on participating in biweekly, nurse-led, virtual diabetes education/skills training and stress/coping intervention) compared to UCT (with no requirement for participation) on clinical outcomes, self-care behaviors, and psychological health in inner city African Americans with poorly controlled T2DM. One hundred (100) individuals will be randomized to either the DM-CCT intervention or the UCT intervention and followed for 6-months, with study visits at baseline, 3-months, and 6-months. The primary outcomes will be glycemic control (HbA1c) and quality of life (SF-12) at 6-months post randomization. The secondary outcomes will be self-care behaviors (diet, exercise, medication adherence) and psychological health (stress, coping) measured at 6-months post randomization. In preparation for future cost effectiveness studies, the final aim will estimate the cost of delivery of the DM-CCT and UCT interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes-Tailored CCTs (DM-CCT) Intervention | Experimental | Participants randomized to DM-CCT will receive cash transfers of $500 per month for 6 months, but the cash transfers will be conditional on attending a 60-minute diabetes education/skills training (30 minutes) and stress/coping (30 minutes) session delivered by trained nurses every 2 weeks for 6 months (12 sessions). Therefore, they will only receive cash transfer payments if they attend two sessions per month. |
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| Unconditional Cash Transfer-UCTs Intervention | Active Comparator | Participants randomized to UCT will receive cash transfers of $500 per month for 6 months, but there will be no conditions attached. Therefore, they will receive cash transfer payments every month. However, to control for content and attention, participants will receive mailed version of the diabetes education/skills training materials every two weeks on the same schedule as the DM-CCT telephone sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DM-CCT | Behavioral | Participants randomized to DM-CCT will receive cash transfers of $500 per month for 6 months, but the cash transfers will be conditional on attending a 60-minute diabetes education/skills training (30 minutes) and stress/coping (30 minutes) session delivered by trained nurses every 2 weeks for 6 months (12 sessions). |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control (HbA1c) | Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c. | Change from baseline HbA1c at 6 months post intervention follow-ups |
| 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 from baseline quality of life measure at 6 months post intervention follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Care | 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. | Change from baseline self-care at 6 months post intervention follow-ups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Campbell, PhD | State University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University at Buffalo | Buffalo | New York | 14203 | United States |
IPD will not be shared with other researchers. Data may be available upon request in aggregate summary form.
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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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| DM-UCT | Behavioral | Participants randomized to UCT will receive cash transfers of $500 per month for 6 months, but there will be no conditions attached. Therefore, they will receive cash transfer payments every month. However, to control for content and attention, participants will receive mailed version of the diabetes education/skills training materials every two weeks on the same schedule as the DM-CCT telephone sessions. |
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| D004700 | Endocrine System Diseases |