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NCT04831697 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Medical College of Wisconsin.

Completed
Registry status
NA
Development phase
60
Enrollment target

NCT04831697: Completed NA study, sponsored by Medical College of Wisconsin.

NCT04831697 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04831697, a NA study, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL Multi-Caregiving Intervention
  • BEHAVIORAL Diabetes Enhanced Usual Care Intervention

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-12-14
Est. Completion 2024-05-31
Phase NA
Medical College of Wisconsin

447 total trials

What the finished NCT04831697 record still lists

NCT04831697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Multi-Caregiving Intervention is the first listed.

NCT04831697 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04831697 about?

NCT04831697 is a clinical study titled "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, heal...

What is the current status of trial NCT04831697?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-12-14. Estimated completion is 2024-05-31.

What interventions are being tested in trial NCT04831697?

The interventions under investigation include: Multi-Caregiving Intervention (BEHAVIORAL), Diabetes Enhanced Usual Care Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT04831697?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04831697's enrollment target sits among peer trials

60 1164th of 2000 higher than 745 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04831697, the US trial registry maintained by the National Library of Medicine. NCT04831697 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.