Clinical trial NCT05559892: Conditional Cash Transfer Intervention to Improve T2DM
Official title: Conditional Cash Transfer Intervention to Improve Health Outcomes Among Inner-City African Americans With T2DM
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycemic control (HbA1c)
timeFrame: Change from baseline HbA1c at 6 months post intervention follow-ups
measure: Quality of Life as measured by SF-12
timeFrame: Change from baseline quality of life measure at 6 months post intervention follow-ups
Secondary outcomes:
measure: Self-Care
timeFrame: Change from baseline self-care at 6 months post intervention follow-ups
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: State University at Buffalo
state: New York
Study officials:
affiliation: State University at Buffalo
name: Jennifer A Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: