Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT04831697
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Multi-Caregiving Intervention — BEHAVIORAL
    The multi-caregiving intervention consists of individual-based, social support, and health educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15 minutes); and Structured Diabetes Education and Skills Training (15 minutes). The last 5 minutes will be used to debrief and review goals.
  • Diabetes Enhanced Usual Care Intervention — BEHAVIORAL
    This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).

Study Details

This is a two arm, pilot randomized control trial (RCT) in which 60 African American women (AAW), 40-64 years of age, with HbA1c ≥8% and multi-caregiving responsibilities will be recruited from communities in Milwaukee, Wisconsin and randomized to either: 1) an individual-based, social support, health educator-facilitated intervention to address multi-caregiving responsibilities (n=30), or 2) individual-based, health educator-facilitated diabetes education and skills training and general health education (n=30). All sessions will be delivered via telephone (i.e., landline, mobile device, smart device, etc.) by a health educator (i.e., nurse, social worker, Master's trained health educator) and is comprised of 12 weekly sessions and 3 booster sessions. Each session will last up to 60min. All study assessments will be administered by a Program Assistant at baseline, 3-months, and 6-months.

Key Dates

Start date
Dec 14, 2021
Status verified
Apr 2026
Primary completion
Feb 22, 2024
Completion
May 31, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Multi-Caregiving Intervention
    The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15minutes); and Structured Diabetes Education and Skills Training (15 minutes). The final 5min will be used for debriefing/reviewing goals.
  • Active Comparator: Diabetes Enhanced Usual Care Intervention
    This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).

Primary Outcome Measure

Mean Change in HbA1c% From Baseline to 6 Months [ Time Frame: Baseline, 6-months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Milwaukee, WI

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Medical College of Wisconsin· Milwaukee, WI

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