Type 2 Diabetes Clinical Trial
— DMCTOfficial 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 30, 2026 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Wisconsin | Wauwatosa | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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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