Conditional Cash Transfer Intervention to Improve T2DM

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT05559892
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-29
• Study Start: 2022-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥18 years
• Self-report as African American
• Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
• Residence in inner city zip codes
• Income greater or equal to133% of federal poverty level or Medicaid eligible
• Able to communicate in English.

Exclusion Criteria

• Mental confusion on interview suggesting significant dementia
• Alcohol or drug abuse/dependency
• Active psychosis or acute mental disorder
• Participation in other diabetes clinical trials
• Life expectancy <6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic control (HbA1c)	Change from baseline HbA1c at 6 months post intervention follow-ups	Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
Quality of Life as measured by SF-12	Change from baseline quality of life measure at 6 months post intervention follow-ups	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.

Secondary Outcome Measures

Name	Time	Method
Self-Care	Change from baseline self-care at 6 months post intervention follow-ups	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.

Trial Locations

Locations (1)

State University at Buffalo; 🇺🇸 Buffalo, New York, United States