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Completed

NCT Number: NCT04831697

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

The investigators propose to test the feasibility and preliminary efficacy of this multi-caregiving intervention on improving outcomes among AAW, ages 40-64 years with type 2 diabetes (T2DM) and multi-caregiving responsibilities using a pilot randomized design compared to diabetes enhanced usual care. The goals of the study will be assessed under the following specific aims:

Aim 1: To determine the feasibility of the multi-caregiving intervention as measured by recruitment, session attendance, retention, and treatment adherence in AAW with T2DM

Aim 2: To test the preliminary efficacy of the multi-caregiving intervention on glycemic and blood pressure control in AAW with T2DM compared to individual-delivered, health-educator led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant reductions in hemoglobin A1c at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant reductions in blood pressure at 6 months compared to AAW who receive diabetes enhanced usual care

Aim 3: To test the preliminary efficacy of the multi-caregiving intervention on self-care behaviors and quality of life in AAW with T2DM compared to individual-delivered, health educator led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant improvements in self-care behaviors (diet, physical activity, medication adherence, and blood glucose monitoring) at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant improvements in quality of life (SF-12 scores) at 6 months compared to AAW who receive diabetes enhanced usual care

In the final 6-month assessment, study participants will be asked to participate in 30 to 40-minute, semi-structured interviews by telephone. Findings will help refine the intervention and emphasize elements that enhance participant uptake and motivation for sustained behavior change for the future R01.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Mean Change in HbA1c% From Baseline to 6 Months

    Time frame: Baseline, 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.

Secondary outcomes

  1. Change in Physical Activity From Baseline to 6 Months

    Time frame: Screening/Baseline, 3-months, 6-months

    Physical activity was measured using the 7-item International Physical Activity Questionnaire (IPAQ) that asks about physical activities over the last 7 days. The minimum and maximum values can vary; however, IPAQ provides ranges for physical activity in MET-minutes per week (MET-min/wk). MET-min/wk: The primary unit, calculated by multiplying minutes per week by the MET value (e.g., walking=3.3, moderate=4.0, vigorous=8.0). Low: No activity or not meeting moderate/high criteria. Moderate: Meeting criteria like 3+ days vigorous activity (≥20 min/day) OR 5+ days moderate/walking (≥30 min/day) OR 5+ days combined (≥600 MET-min/wk). High: Meeting criteria like 3+ days vigorous activity (≥1500 MET-min/wk) OR 7+ days combined (≥3000 MET-min/wk).

  2. Change in Blood Pressure Control From Baseline to 6 Months

    Time frame: Screening/Baseline, 3-months, 6-months

    Blood pressure measurements were obtained by the nurse/health educator using an automated BP monitor with participants seated comfortably for 5 minutes prior to the measurements.

  3. Change in Blood Glucose Monitoring From Baseline to 6 Months

    Time frame: Screening/Baseline, 3-months, 6-months

    Blood glucose monitoring was assessed with the previously validated Summary of Diabetes Self-Care Activities (SDSCA) scale, where scores are calculated for each of the five areas assessed by the SDSCA over the past 7 days: diet, exercise, blood glucose monitoring, foot care, and smoking status. Higher scores mean more engagement in self-care behaviors.

  4. Change in Medication Adherence From Baseline to 6 Months

    Time frame: Screening/Baseline, 3-months, 6-months

    Medication adherence was measured with the 6-item validated self-report Brooks Medication Adherence Scale. Each question asks yes-no questions about adherence, where a "no" response indicates better adherence.

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

    Time frame: Screening/Baseline, 3-months, 6-months

    The SF-12 is a valid and reliable instrument that was used to measure functional status and yielded summary physical (PCS-12) and mental health (MCS-12) outcome scores. Summary scores range from 0 to 100 where higher scores mean better quality of life.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Acronym: MCG-DM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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