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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Multi-Caregiving Intervention; Behavioral: Diabetes Enhanced Usual Care Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joni Williams, MD, MPH; Phone Number: 414-955-8827; Email: jswilliams@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Joni Williams, MD, MPH; Phone Number: 414-955-8827; Email: jswilliams@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 62 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-Caregiving Intervention; 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; 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.
Active Comparator: Diabetes Enhanced Usual Care Intervention; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Screening/Baseline, 3-months, 6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Screening/Baseline, 3-months, 6-months
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.	Screening/Baseline, 3-months, 6-months
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.	Screening/Baseline, 3-months, 6-months
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.	Screening/Baseline, 3-months, 6-months
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.	Screening/Baseline, 3-months, 6-months
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.	Screening/Baseline, 3-months, 6-months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Joni Williams, MD, MPH, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stress, Psychological; Diabetes Mellitus; Caregiver Burden
• Other Study ID Numbers: R21DK123720 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No