Clinical trial NCT04831697: Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden
Official title: Community-Based Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Glycemic Control from Baseline to 6 months
timeFrame: Screening/Baseline, 3-months, 6-months
Secondary outcomes:
measure: Change in Diet from Baseline to 6 months
timeFrame: Screening/Baseline, 3-months, 6-months
measure: Change in Physical Activity from Baseline to 6 months
timeFrame: Screening/Baseline, 3-months, 6-months
measure: Change in Blood Pressure Control from Baseline to 6 months
timeFrame: Screening/Baseline, 3-months, 6-months
measure: Change in Blood Glucose Monitoring from Baseline to 6 months
timeFrame: Screening/Baseline, 3-months, 6-months
measure: Change in Medication Adherence from Baseline to 6 months
timeFrame: Screening/Baseline, 3-months, 6-months
measure: Change in Health Related Quality of Life from Baseline to 6 months
timeFrame: Screening/Baseline, 3-months, 6-months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Joni Williams, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: