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Conditional Cash Transfer Intervention to Improve 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.
Conditions:
🦠 Type 2 Diabetes
🗓️ Study Start (Actual) 1 November 2022
🗓️ Primary Completion (Estimated) 30 November 2026
✅ Study Completion (Estimated) 30 November 2026
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Buffalo, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 September 2022
  • First Submitted that Met QC Criteria 28 September 2022
  • First Posted 29 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 July 2024
  • Last Update Posted 12 July 2024
  • Last Verified July 2024
I'm interested ...!!