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

NCT04831697 | Completed Results DMC

• 1 other identifier: R21DK123720
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Change in HbA1c% From Baseline to 6 Months

  Trained personnel collected 100cc of blood via venipuncture to measure hemoglobin A1c (HbA1c). All collections were performed in the community at a location convenient for the study participant. At the screening visit, the HbA1c had to be 8% or greater to be eligible for participation.

  Baseline, 6-months

Secondary Outcomes (5)

• Change in Physical Activity From Baseline to 6 Months

  Screening/Baseline, 3-months, 6-months

• Change in Blood Pressure Control From Baseline to 6 Months

  Screening/Baseline, 3-months, 6-months

• Change in Blood Glucose Monitoring From Baseline to 6 Months

  Screening/Baseline, 3-months, 6-months

• Change in Medication Adherence From Baseline to 6 Months

  Screening/Baseline, 3-months, 6-months

• Change in Health Related Quality of Life From Baseline to 6 Months

  Screening/Baseline, 3-months, 6-months

Study Arms (2)

Multi-Caregiving Intervention

EXPERIMENTAL

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.

Behavioral: Multi-Caregiving Intervention

Diabetes Enhanced Usual Care Intervention

ACTIVE COMPARATOR

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).

Behavioral: Diabetes Enhanced Usual Care Intervention

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.

Multi-Caregiving Intervention

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).

Diabetes Enhanced Usual Care Intervention

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 40-64 years
• Self-identifies as female
• Self-identifies as African American or Non-Hispanic Black
• Self-reports multi-caregiving responsibilities
• Clinical diagnosis of T2DM based on HbA1c≥8% at the screening/baseline assessment
• Able to communicate in English
• Access to a telephone (i.e., landline, mobile device, smart device, etc.)

You may not qualify if:

• Mental confusion at screening/baseline assessment suggesting significant dementia, active psychosis, or acute mental disorder
• Participation in other diabetes trials
• Life expectancy \<6 months based on screening questionnaire

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

There are no limitations or caveats to report.

Results Point of Contact

• Title: Joni S. Williams
• Organization: Medical College of Wisconsin

jswilliams@mcw.edu

414.955.8827

Study Officials

• Joni Williams, MD, MPH

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 5, 2021
• Study Start: December 14, 2021
• Primary Completion: February 22, 2024
• Study Completion: May 31, 2024
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Locations

US (1)