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Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden (MCGR21)

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Caregiving Intervention
Diabetes Enhanced Usual Care Intervention
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multi-Caregiving Intervention

Diabetes Enhanced Usual Care Intervention

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in Glycemic Control from Baseline to 6 months
Trained personnel will collect a blood specimen via finger stick (using a Point-of-Care device) or via venipuncture to collect 10cc of blood to measure HbA1c. All collections will be performed in the community at a location convenient to the study participant. At the screening visit, the HbA1c must be 8% or greater to be eligible for participation.

Secondary Outcome Measures

Change in Diet from Baseline to 6 months
Diet will be measured by the 26-item Dietary Screener Questionnaire (DSQ) used in the National Health and Nutrition Examination Survey. Responses are used to estimate individual dietary intake for fruits, vegetables, dairy, added sugars, whole grains, fiber, adn calcium.
Change in Physical Activity from Baseline to 6 months
Physical activity will be measured using the 7-item International Physical Activity Questionnaire that asks about physical activities over the last 7 days.
Change in Blood Pressure Control from Baseline to 6 months
Blood pressure measurements will be obtained by the nurse/health educator using an automated BP monitor with participants seated comfortably for 5 minutes prior to the measurements.
Change in Blood Glucose Monitoring from Baseline to 6 months
Blood glucose monitoring will be 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.
Change in Medication Adherence from Baseline to 6 months
Medication adherence will be 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.
Change in Health Related Quality of Life from Baseline to 6 months
The SF-12 is a valid and reliable instrument to measure functional status and yields 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.

Full Information

First Posted
March 25, 2021
Last Updated
May 18, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04831697
Brief Title
Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden
Acronym
MCGR21
Official Title
Community-Based Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-Caregiving Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Diabetes Enhanced Usual Care Intervention
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Multi-Caregiving Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Enhanced Usual Care Intervention
Intervention Description
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 Information:
Title
Change in Glycemic Control from Baseline to 6 months
Description
Trained personnel will collect a blood specimen via finger stick (using a Point-of-Care device) or via venipuncture to collect 10cc of blood to measure HbA1c. All collections will be performed in the community at a location convenient to the study participant. At the screening visit, the HbA1c must be 8% or greater to be eligible for participation.
Time Frame
Screening/Baseline, 3-months, 6-months
Secondary Outcome Measure Information:
Title
Change in Diet from Baseline to 6 months
Description
Diet will be measured by the 26-item Dietary Screener Questionnaire (DSQ) used in the National Health and Nutrition Examination Survey. Responses are used to estimate individual dietary intake for fruits, vegetables, dairy, added sugars, whole grains, fiber, adn calcium.
Time Frame
Screening/Baseline, 3-months, 6-months
Title
Change in Physical Activity from Baseline to 6 months
Description
Physical activity will be measured using the 7-item International Physical Activity Questionnaire that asks about physical activities over the last 7 days.
Time Frame
Screening/Baseline, 3-months, 6-months
Title
Change in Blood Pressure Control from Baseline to 6 months
Description
Blood pressure measurements will be obtained by the nurse/health educator using an automated BP monitor with participants seated comfortably for 5 minutes prior to the measurements.
Time Frame
Screening/Baseline, 3-months, 6-months
Title
Change in Blood Glucose Monitoring from Baseline to 6 months
Description
Blood glucose monitoring will be 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.
Time Frame
Screening/Baseline, 3-months, 6-months
Title
Change in Medication Adherence from Baseline to 6 months
Description
Medication adherence will be 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.
Time Frame
Screening/Baseline, 3-months, 6-months
Title
Change in Health Related Quality of Life from Baseline to 6 months
Description
The SF-12 is a valid and reliable instrument to measure functional status and yields 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.
Time Frame
Screening/Baseline, 3-months, 6-months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joni Williams, MD, MPH
Phone
414-955-8827
Email
jswilliams@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joni Williams, MD, MPH
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joni Williams, MD, MPH
Phone
414-955-8827
Email
jswilliams@mcw.edu

12. IPD Sharing Statement

Learn more about this trial

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

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