Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2P30AG024824-16 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Blue Cross Blue Shield of Michigan Foundation | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Leader Diabetes Self-Management Support (PLDSMS) | Experimental | 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. |
|
| Control Group | Active Comparator | Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Leader Diabetes Self-Management Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Male
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaclynn Hawkins, MSW, PhD | University of Michigan, School of Social Work | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33752609 | Derived | Hawkins J, Kloss K, Funnell M, Nwankwo R, Schwenzer C, Smith F, Piatt G. Michigan Men's diabetes project (MenD): protocol for a peer leader diabetes self-management education and support intervention. BMC Public Health. 2021 Mar 22;21(1):562. doi: 10.1186/s12889-021-10613-2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not all participants came to every health assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Error | percent of hemoglobin A1c | 3 months |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not all participants were able to go to every health assessment and every support session with the Certified Diabetes Care and Education Specialist.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaclynn Hawkins | University of Michigan School of Social Work | (734) 647-4072 | jachawk@umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2021 | Jan 26, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Virtual Diabetes Self-Management Education | Behavioral | 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 | 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. | 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. | 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. | 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.' | 3 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1C | Mean | Standard Deviation | percent Hemoglobin A1C |
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Error | kg/m^2 | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Error | mmHg | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 3 months |
|
|
|
| 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.' | Posted | Mean | Standard Error | units on a scale | 3 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| Exercise |
|
| Blood-Glucose Testing |
|
| Foot Care |
|