Trial Outcomes & Findings for Michigan Men's Diabetes Project (NCT NCT04760444)
NCT ID: NCT04760444
Last Updated: 2023-06-22
Results Overview
This outcome measure is change in hemoglobin A1C measured using the DCA 2000 point-of-care testing instrument (value at 3 months minus value at baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
3 months
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Michigan Men's Diabetes Project
Baseline characteristics by cohort
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
n=12 Participants
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
n=13 Participants
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Hemoglobin A1C
|
7.7 percent Hemoglobin A1C
STANDARD_DEVIATION 2.2 • n=5 Participants
|
7.4 percent Hemoglobin A1C
STANDARD_DEVIATION 1.3 • n=7 Participants
|
7.5 percent Hemoglobin A1C
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThis outcome measure is change in hemoglobin A1C measured using the DCA 2000 point-of-care testing instrument (value at 3 months minus value at baseline).
Outcome measures
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
n=12 Participants
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
n=13 Participants
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
|---|---|---|
|
Hemoglobin A1C
|
-0.20 percent of hemoglobin A1c
Standard Error 0.30
|
-0.13 percent of hemoglobin A1c
Standard Error 0.31
|
PRIMARY outcome
Timeframe: 3 monthsThis outcome measure is change in self-care activities as measured by the Summary of Diabetes Self-Care Activities (SDSCA) scale (value at 3 months minus value at baseline). The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. The range for the general diet, specific diet, exercise, blood-glucose testing, and foot care sub scales included below is 0 to 7. Higher scores are indicative of more frequent self-care activities compared to lower scores.
Outcome measures
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
n=12 Participants
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
n=13 Participants
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
|---|---|---|
|
Self-Care Activities
General Diet
|
1.32 units on a scale
Standard Error 0.51
|
1.77 units on a scale
Standard Error 0.98
|
|
Self-Care Activities
Specific Diet
|
0.27 units on a scale
Standard Error 0.61
|
0.74 units on a scale
Standard Error 0.49
|
|
Self-Care Activities
Exercise
|
0.95 units on a scale
Standard Error 0.56
|
2.02 units on a scale
Standard Error 1.44
|
|
Self-Care Activities
Blood-Glucose Testing
|
0.50 units on a scale
Standard Error 0.22
|
2.44 units on a scale
Standard Error 1.89
|
|
Self-Care Activities
Foot Care
|
0.41 units on a scale
Standard Error 0.53
|
0.04 units on a scale
Standard Error 0.96
|
SECONDARY outcome
Timeframe: 3 monthsThis outcome measure is change in BMI (value at 3 months minus value at baseline). BMI was calculated using height and weight. Height was measured using a stadiometer. Weight was measured on a high quality, calibrated digital scale. The BMI categories are: Underweight = \<18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater.
Outcome measures
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
n=12 Participants
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
n=13 Participants
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
|---|---|---|
|
Body Mass Index (BMI)
|
-0.31 kg/m^2
Standard Error 0.29
|
-0.41 kg/m^2
Standard Error 0.50
|
SECONDARY outcome
Timeframe: 3 monthsThe outcome measure is the change in blood pressure (value at 3 months minus value at baseline). Blood pressure was measured using the auscultatory method.
Outcome measures
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
n=12 Participants
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
n=13 Participants
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
|---|---|---|
|
Blood Pressure
Diastolic
|
-1.33 mmHg
Standard Error 2.52
|
0.15 mmHg
Standard Error 7.3
|
|
Blood Pressure
Systolic
|
-5.23 mmHg
Standard Error 2.58
|
10.34 mmHg
Standard Error 8.17
|
SECONDARY outcome
Timeframe: 3 monthsThis outcome measure is change in depressive symptom severity as measured by the Patient Health Questionnaire-2 (PHQ-2) Scale (value at 3 months minus value at baseline). Scores range from 0 to 6. Higher scores are indicative of more depressive symptoms.
Outcome measures
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
n=12 Participants
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
n=13 Participants
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
|---|---|---|
|
Depressive Symptom Severity
|
-0.45 units on a scale
Standard Error 0.55
|
0.09 units on a scale
Standard Error 0.52
|
SECONDARY outcome
Timeframe: 3 monthsThis outcome measure is change in diabetes self-efficacy as measured by the 8-item Diabetes Self-Efficacy Scale (DSES) (value at 3 months minus value at baseline). The scores for this scale range from 1 to 10. Higher scores are indicative of higher self-efficacy.
Outcome measures
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
n=12 Participants
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
n=13 Participants
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
|---|---|---|
|
Diabetes Self-Efficacy
|
0.27 units on a scale
Standard Error 0.48
|
0.33 units on a scale
Standard Error 0.78
|
SECONDARY outcome
Timeframe: 3 monthsThis outcome measure is change in diabetes distress as measured by the 17-item Diabetes Distress Scale (DDS17) (value at 3 months minus value at baseline). Scores for the DDS17 range from 1 to 6. Higher scores are indicate higher diabetes distress. A score of 2 - 2.9 is considered 'moderate distress,' and a score greater than 3.0 is considered 'high distress.'
Outcome measures
| Measure |
Peer Leader Diabetes Self-Management Support (PLDSMS)
n=12 Participants
Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.
Peer Leader Diabetes Self-Management Support: While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
Control Group
n=13 Participants
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Virtual Diabetes Self-Management Education: Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
|
|---|---|---|
|
Diabetes Distress
|
-3.91 units on a scale
Standard Error 2.55
|
-0.68 units on a scale
Standard Error 3.28
|
Adverse Events
Peer Leader Diabetes Self-Management Support (PLDSMS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jaclynn Hawkins
University of Michigan School of Social Work
Phone: (734) 647-4072
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place