Type 2 Diabetes Clinical Trial
Official title:
Conditional Cash Transfer Intervention to Improve Health Outcomes Among Inner-City African Americans With T2DM
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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