Trial Outcomes & Findings for Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden (NCT NCT04831697)
NCT ID: NCT04831697
Last Updated: 2026-04-28
Results Overview
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.
COMPLETED
NA
60 participants
Baseline, 6-months
2026-04-28
Participant Flow
Recruitment occurred through community outreach and engagement in collaboration with community partners. Study information, eligibility criteria, and contact information for study personnel were detailed in correspondence materials of community partners and their affiliated networks. The recruitment flyer was displayed prominently in locations throughout the community. Self-referral/word-of-mouth was encouraged in response to recruitment flyers, the snowball method, and study advertisements.
Participant milestones
| Measure |
Multi-caregiving Intervention
The multi-caregiving intervention consisted 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 were used for debriefing/reviewing goals.
|
Enhanced Usual Care
This comparator group was composed of individual-based, health educator-facilitated diabetes education and skills training (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Multi-caregiving Intervention
The multi-caregiving intervention consisted 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 were used for debriefing/reviewing goals.
|
Enhanced Usual Care
This comparator group was composed of individual-based, health educator-facilitated diabetes education and skills training (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study.
Baseline characteristics by cohort
| Measure |
Multi-Caregiving Intervention
n=29 Participants
The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: 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.
|
Diabetes Enhanced Usual Care Intervention
n=31 Participants
This arm included individual-based, health educator-facilitated diabetes education and skills training (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=9 Participants
|
54 years
n=24 Participants
|
54 years
n=23 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=9 Participants • A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study.
|
31 Participants
n=24 Participants • A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study.
|
60 Participants
n=23 Participants • A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study.
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants • A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study.
|
0 Participants
n=24 Participants • A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study.
|
0 Participants
n=23 Participants • A total of 60 Black women between the ages of 40-64, in the sandwich and club-sandwich generations, with multi-caregiving responsibilities, defined as the provision of informal care (emotional, physical/tangible, financial, spiritual support) to parents/grandparents, children/grandchildren, significant others, or others in their social networks within the larger community, were enrolled in the study.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=24 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=23 Participants • A total of 60 Black women were enrolled in the study.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=24 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=23 Participants • A total of 60 Black women were enrolled in the study.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=24 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=23 Participants • A total of 60 Black women were enrolled in the study.
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=9 Participants • A total of 60 Black women were enrolled in the study.
|
31 Participants
n=24 Participants • A total of 60 Black women were enrolled in the study.
|
60 Participants
n=23 Participants • A total of 60 Black women were enrolled in the study.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=24 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=23 Participants • A total of 60 Black women were enrolled in the study.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=24 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=23 Participants • A total of 60 Black women were enrolled in the study.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=24 Participants • A total of 60 Black women were enrolled in the study.
|
0 Participants
n=23 Participants • A total of 60 Black women were enrolled in the study.
|
|
Glycemic Control (Measured by HbA1c)
|
9.20 %
n=9 Participants
|
9.90 %
n=24 Participants
|
9.65 %
n=23 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6-monthsTrained 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.
Outcome measures
| Measure |
Multi-Caregiving Intervention
n=29 Participants
The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: 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.
|
Diabetes Enhanced Usual Care Intervention
n=31 Participants
This arm included individual-based, health educator-facilitated diabetes education and skills training as described in the multi-caregiving intervention (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).
|
|---|---|---|
|
Mean Change in HbA1c% From Baseline to 6 Months
|
0.57 Mean Change in HbA1c%
Interval -0.19 to 1.3
|
0.53 Mean Change in HbA1c%
Interval 0.29 to 0.78
|
SECONDARY outcome
Timeframe: Screening/Baseline, 3-months, 6-monthsPhysical 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening/Baseline, 3-months, 6-monthsBlood 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening/Baseline, 3-months, 6-monthsBlood 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening/Baseline, 3-months, 6-monthsMedication 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening/Baseline, 3-months, 6-monthsThe 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.
Outcome measures
Outcome data not reported
Adverse Events
Multi-Caregiving Intervention
Diabetes Enhanced Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place