An interventional study of Peer Leader Diabetes Self-Management Support and Virtual Diabetes Self-Management Education in Diabetes Mellitus, Type 2, sponsored by University of Michigan. Completed at 1 site in United States. Open to male participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
The investigators propose to develop a training for male peer leaders facilitating diabetes self-management education and support (DSMES) to specifically encourage conversations regarding beliefs that affect men's health and to allow modeling of alternative views and perspectives that allow for successful disease management to be framed as competence and strength. Given that the life expectancy for Black men in the US is 71, the investigators hypothesize that targeting men in earlier stages of type 2 diabetes (T2D) will assist greatly in facilitating healthy aging and improving diabetes-related health outcomes later in life.
Based on the investigators previous work, the long-term goal of our research is to determine the most effective, practical, and sustainable approach to provide DSMES to older Black men. The objective is to examine the relative effectiveness, feasibility, and acceptability of a peer-leader DSMES intervention for Black men with T2D. To accomplish this, the investigators will engage in a developmental phase and a validation phase [pilot randomized control trial (RCT)]. The RCT will be conducted with 60 Black adult male residents of metro Detroit, Michigan. Participants will be randomized to a control group or the tailored peer-leader diabetes self-management support group (PLDSMS). All participants will receive DSME with a certified diabetes care and education specialists. Only participants randomized to the PLDSMS group will also receive an additional 6 weeks of DSMS led by the peer leaders. The investigators hypothesize that 1) participants in the PLDSMS group will have improved outcomes (A1c, blood pressure, weight, diabetes distress, self-management behaviors, etc.) over the control group, and 2) an evaluation of measures will confirm efficacy of the PLDSMS.
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Exclusion Criteria:
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.
Behavioral: Peer Leader Diabetes Self-Management Support · Behavioral: Virtual Diabetes Self-Management Education
Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.
Behavioral: Virtual Diabetes Self-Management Education
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.
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
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).
Time frame: 3 months
Self-Care Activities
This 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.
Time frame: 3 months
Body Mass Index (BMI)
This 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.
Time frame: 3 months
Blood Pressure
The outcome measure is the change in blood pressure (value at 3 months minus value at baseline). Blood pressure was measured using the auscultatory method.
Time frame: 3 months
Depressive Symptom Severity
This 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.
Time frame: 3 months
Diabetes Self-Efficacy
This 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.
Time frame: 3 months
Diabetes Distress
This 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.'
Time frame: 3 months
| Milestone | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group |
|---|---|---|
| Started | 12 | 13 |
| Completed | 11 | 8 |
| Not completed | 1 | 5 |
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).
| percent of hemoglobin A1c | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group |
|---|---|---|
| Hemoglobin A1C | -0.20 ± 0.30 | -0.13 ± 0.31 |
This 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.
| units on a scale | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group |
|---|---|---|
| General Diet | 1.32 ± 0.51 | 1.77 ± 0.98 |
| Specific Diet | 0.27 ± 0.61 | 0.74 ± 0.49 |
| Exercise | 0.95 ± 0.56 | 2.02 ± 1.44 |
| Blood-Glucose Testing | 0.50 ± 0.22 | 2.44 ± 1.89 |
| Foot Care | 0.41 ± 0.53 | 0.04 ± 0.96 |
This 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.
| kg/m^2 | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group |
|---|---|---|
| Body Mass Index (BMI) | -0.31 ± 0.29 | -0.41 ± 0.50 |
The outcome measure is the change in blood pressure (value at 3 months minus value at baseline). Blood pressure was measured using the auscultatory method.
| mmHg | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group |
|---|---|---|
| Systolic | -5.23 ± 2.58 | 10.34 ± 8.17 |
| Diastolic | -1.33 ± 2.52 | 0.15 ± 7.3 |
This 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.
| units on a scale | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group |
|---|---|---|
| Depressive Symptom Severity | -0.45 ± 0.55 | 0.09 ± 0.52 |
This 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.
| units on a scale | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group |
|---|---|---|
| Diabetes Self-Efficacy | 0.27 ± 0.48 | 0.33 ± 0.78 |
This 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.'
| units on a scale | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group |
|---|---|---|
| Diabetes Distress | -3.91 ± 2.55 | -0.68 ± 3.28 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Control Group | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
Not all participants came to every health assessment.
| Age, Categorical(Participants) | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 9 | 15 |
| >=65 years | 6 | 4 | 10 |
| Age, Continuous(years) | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group | Total |
|---|---|---|---|
| Mean | 62.1 ± 5.8 | 64.4 ± 5.6 | 62.8 ± 7.1 |
| Sex: Female, Male(Participants) | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 12 | 13 | 25 |
| Race (NIH/OMB)(Participants) | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 13 | 25 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group | Total |
|---|---|---|---|
| United States | 12 | 13 | 25 |
| Hemoglobin A1C(percent Hemoglobin A1C) | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group | Total |
|---|---|---|---|
| Mean | 7.7 ± 2.2 | 7.4 ± 1.3 | 7.5 ± 1.7 |
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