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Michigan Men's Diabetes Project

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ClinicalTrials.gov Identifier: NCT04760444
Recruitment Status : Not yet recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Collaborators:
Blue Cross Blue Shield of Michigan Foundation
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jaclynn Hawkins, University of Michigan

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 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, MI. 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Peer Leader Diabetes Self-Management Support Behavioral: Virtual Diabetes Self-Management Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Michigan Men's Diabetes Project (MenD) - Peer Leader Intervention
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Active Comparator: 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.
Behavioral: 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 Outcome Measures :
  1. Diabetes Self-Management [ Time Frame: 6 months ]
    Measured by the Perceived Diabetes Self-Management Scale: An 8-item Perceived Diabetes Self-Management Scale (PDSMS). The responses for the PDSMS items range from 1 = "Strongly Disagree" to 5 = "Strongly Agree." Four of the items (#s 1, 2, 6, & 7) are worded such that high agreement signifies low self-efficacy or perceived competence. These four items are reverse scored prior to being added to the other four items. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.

  2. Metabolic Control [ Time Frame: 6 months ]
    Hemoglobin A1c measured using the DCA 2000 point-of-care testing instrument


Secondary Outcome Measures :
  1. Adherence to Gender Norms [ Time Frame: 6 months ]
    Measured using the Male Role Norms Inventory

  2. Height [ Time Frame: 6 months ]
    Measured in inches using a stadiometer

  3. Blood Pressure [ Time Frame: 6 months ]
    Measured using the auscultatory method

  4. Diabetes Social Support [ Time Frame: 6 months ]
    Measured using the Diabetes Social Support Questionnaire

  5. Diabetes-related Distress [ Time Frame: 6 months ]
    The DDS17 yields a total diabetes distress score plus 4 subscale scores, each addressing a different kind of distress.1 To score, simply sum the patient's responses to the appropriate items and divide by the number of items in that scale. Current research2 suggests that a mean item score 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score > 3.0 should be considered 'high distress.' Current research also indicates that associations between DDS scores and behavioral management and biological variables (e.g., A1C) occur with DDS scores of > 2.0. Clinicians may consider moderate or high distress worthy of clinical attention, depending on the clinical context.

  6. Diabetes Quality of Life [ Time Frame: 6 months ]
    The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Using a norm-based algorithm it produces a composite score for self-reported mental and physical between 0 and 100, which allows for comparison between study populations and national averages. Responses to SF-12v2 questions were used to estimate a mental composite score (MCS) and physical composite score (PCS) for each subject on a 0- and 100- point scale in accordance with the methods outlined by Ware et al. (2000). The national mean scores for both mental and physical health are standardized at 50; scores above this represent higher, or healthier, individuals than average.

  7. Weight [ Time Frame: 6 months ]
    Measured in pounds using a high quality, calibrated digital scale



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760444


Contacts
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Contact: Katherine Kloss, B.S. 734-936-3773 klossk@med.umich.edu

Sponsors and Collaborators
University of Michigan
Blue Cross Blue Shield of Michigan Foundation
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Jaclynn Hawkins, MSW, PhD University of Michigan, School of Social Work
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Responsible Party: Jaclynn Hawkins, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04760444    
Other Study ID Numbers: MenD HUM00190932
2P30AG024824-16 ( U.S. NIH Grant/Contract )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases