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Type 2 DiabetesMCG-DMNCT04831697

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

A study testing Multi-Caregiving Intervention in people with Type 2 Diabetes, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 64 years, women only
Conditions the study is for
Type 2 Diabetes
What is being tested?
Multi-Caregiving Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
14 Dec 2021to 31 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 64 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: Community-Based 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.

Read the detailed description

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.

Conditions
Type 2 Diabetes
Being tested
Multi-Caregiving Intervention, Diabetes Enhanced Usual Care Intervention
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Caregiving InterventionBehavioural

    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 InterventionBehavioural

    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 groups in NCT04831697
Study groupRoleWhat they receive
Multi-Caregiving InterventionExperimentalThe 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.
Receives: Behavioral: Multi-Caregiving Intervention
Diabetes Enhanced Usual Care InterventionActive comparatorThis 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).
Receives: Behavioral: Diabetes Enhanced Usual Care Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 6-months

Secondary outcomes (5)

  1. Change in Physical Activity From Baseline to 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).

    Measured: Screening/Baseline, 3-months, 6-months

  2. Change in Blood Pressure Control From Baseline to 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.

    Measured: Screening/Baseline, 3-months, 6-months

  3. Change in Blood Glucose Monitoring From Baseline to 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.

    Measured: Screening/Baseline, 3-months, 6-months

  4. Change in Medication Adherence From Baseline to 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.

    Measured: Screening/Baseline, 3-months, 6-months

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

    Measured: Screening/Baseline, 3-months, 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start14 Dec 2021
  3. Primary completion22 Feb 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04831697
Sponsor's protocol ID
R21DK123720
Acronym
MCG-DM
Status last verified
Apr 2026
First submitted
25 Mar 2021
Last updated
28 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Caregiving Intervention in people with Type 2 Diabetes, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in HbA1c% From Baseline to 6 Months (time frame: Baseline, 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04831697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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MCG-DM Clinical Trial NCT04831697 | AzTrials