Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
BEHAVIORALPeer 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.
BEHAVIORALVirtual 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.
Sponsors
Blue Cross Blue Shield of Michigan Foundation
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male * Age 55 or older * Black/African American * Diagnosis of type 2 diabetes for a six-month duration or longer.
Exclusion criteria
* Non-ambulatory * Serious health conditions (morbid obesity and severe symptomatic heart disease, visual impairment, renal failure, and peripheral neuropathy) * Psychiatric illness (severity requiring hospitalization) * Cognitive deficit * Serious diabetes complications (e.g. blindness) that would impede meaningful participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 3 months | 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). |
| Self-Care Activities | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptom Severity | 3 months | 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. |
| Body Mass Index (BMI) | 3 months | 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. |
| Diabetes Distress | 3 months | 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.' |
| Diabetes Self-Efficacy | 3 months | 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. |
| Blood Pressure | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | Peer Leader Diabetes Self-Management Support (PLDSMS) | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 9 Participants | 15 Participants |
| Age, Continuous | 62.1 years STANDARD_DEVIATION 5.8 | 64.4 years STANDARD_DEVIATION 5.6 | 62.8 years STANDARD_DEVIATION 7.1 |
| Hemoglobin A1C | 7.7 percent Hemoglobin A1C STANDARD_DEVIATION 2.2 | 7.4 percent Hemoglobin A1C STANDARD_DEVIATION 1.3 | 7.5 percent Hemoglobin A1C STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 13 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 12 participants | 13 participants | 25 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Hemoglobin A1C | -0.20 percent of hemoglobin A1c | Standard Error 0.3 |
| Control Group | Hemoglobin A1C | -0.13 percent of hemoglobin A1c | Standard Error 0.31 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Self-Care Activities | General Diet | 1.32 units on a scale | Standard Error 0.51 |
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Self-Care Activities | Exercise | 0.95 units on a scale | Standard Error 0.56 |
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Self-Care Activities | Blood-Glucose Testing | 0.50 units on a scale | Standard Error 0.22 |
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Self-Care Activities | Foot Care | 0.41 units on a scale | Standard Error 0.53 |
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Self-Care Activities | Specific Diet | 0.27 units on a scale | Standard Error 0.61 |
| Control Group | Self-Care Activities | Foot Care | 0.04 units on a scale | Standard Error 0.96 |
| Control Group | Self-Care Activities | General Diet | 1.77 units on a scale | Standard Error 0.98 |
| Control Group | Self-Care Activities | Specific Diet | 0.74 units on a scale | Standard Error 0.49 |
| Control Group | Self-Care Activities | Blood-Glucose Testing | 2.44 units on a scale | Standard Error 1.89 |
| Control Group | Self-Care Activities | Exercise | 2.02 units on a scale | Standard Error 1.44 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Blood Pressure | Systolic | -5.23 mmHg | Standard Error 2.58 |
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Blood Pressure | Diastolic | -1.33 mmHg | Standard Error 2.52 |
| Control Group | Blood Pressure | Systolic | 10.34 mmHg | Standard Error 8.17 |
| Control Group | Blood Pressure | Diastolic | 0.15 mmHg | Standard Error 7.3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Body Mass Index (BMI) | -0.31 kg/m^2 | Standard Error 0.29 |
| Control Group | Body Mass Index (BMI) | -0.41 kg/m^2 | Standard Error 0.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Depressive Symptom Severity | -0.45 units on a scale | Standard Error 0.55 |
| Control Group | Depressive Symptom Severity | 0.09 units on a scale | Standard Error 0.52 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Diabetes Distress | -3.91 units on a scale | Standard Error 2.55 |
| Control Group | Diabetes Distress | -0.68 units on a scale | Standard Error 3.28 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Diabetes Self-Efficacy | 0.27 units on a scale | Standard Error 0.48 |
| Control Group | Diabetes Self-Efficacy | 0.33 units on a scale | Standard Error 0.78 |