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Peers LEAD Plus Healthy Living With Diabetes (HLWD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04857411
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The specific goal of this project is to decrease diabetes-related morbidity among African Americans (AAs) in Milwaukee through the integration of Peers LEAD, a culturally-appropriate program to increase medication adherence into Healthy Living with Diabetes (HLWD), an existing diabetes self-management program.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Peers LEAD plus HLWD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Diabetes Programs for Blacks in Wisconsin: Peers as Coaches in Medicine Use
Actual Study Start Date : April 19, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Participant 'Buddies'
Participants will have an 8-week program initiation phase followed by a maintenance phase through 6-months, supported by Ambassadors.
Behavioral: Peers LEAD plus HLWD
Combined Peers LEAD and Healthy Living with Diabetes is a culturally-appropriate program to increase medication adherence




Primary Outcome Measures :
  1. Mean Hemoglobin A1c [ Time Frame: baseline ]
    Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.

  2. Mean Hemoglobin A1c [ Time Frame: 3 months ]
    Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.

  3. Mean Hemoglobin A1c [ Time Frame: 6 months ]
    Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.

  4. Mean Systolic Blood Pressure [ Time Frame: baseline ]
    Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

  5. Mean Systolic Blood Pressure [ Time Frame: 3 months ]
    Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

  6. Mean Systolic Blood Pressure [ Time Frame: 6 months ]
    Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.

  7. Change in Diastolic Blood Pressure [ Time Frame: baseline, 3 months, 6 months ]
    Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.


Secondary Outcome Measures :
  1. Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Score [ Time Frame: baseline, 3 months, 6 months ]
    ARMS-D is a measure of medication adherence. It is an 11-item survey with a total possible range of scores 11-44. Lower scores indicate better medication adherence.

  2. Self-Efficacy for Adherence to Medication Use Scale (SEAMS) [ Time Frame: baseline, 3 months, 6 months ]
    SEAMS is a 16-item questionnaire that assesses peoples' confidence in taking their medications correctly, which can be used to determine medication self-efficacy in a person with diabetes. Current evidence exists demonstrating the reliability and validity of the SEAMS instrument. Respondents are asked to indicate, under a number of different circumstances, their level of confidence about taking medications correctly. Each item is evaluated using a 3-point Likert-type scale (1 = not confident, 2 = somewhat confident, and 3 = very confident). The sum of SEAMS ranges from 13 to 39. Higher scores reflect that respondents have more confidence in being adherent to their medication use.

  3. Patient's Perceived Involvement in Care Scale (PICS) [ Time Frame: baseline, 3 months, 6 months ]

    PICS is a brief, psychometrically-sound, self-report questionnaire about primary care patients' attitudes regarding their illnesses and the management of them. This instrument is designed to examine three relatively distinct factors: (1) doctor facilitation of patient involvement, (2) level of information exchange, and (3) patient participation in decision making.

    This instrument evaluates doctor-patient interactions across three relatively distinct factors, including doctor facilitation of patient involvement (5 items), level of information exchange (4 items), and patient participation in decision making (4 items). In total, respondents answer 13 dichotomous items (0 point is given for "no" and 1 point for "yes.") Items scores are summed to generate a total score ranging from 0-13, and higher scores suggest a greater degree of shared decision making for disease self-management.


  4. Diabetes Distress Scale (DDS) 2 [ Time Frame: baseline, 3 months, 6 months ]
    The DDS-2 is a 2-item screener version of the reliable and valid 17-item DDS questionnaire, which is constructed for people with type 2 diabetes. The DDS-2 is a simple method to evaluate peoples' feelings about being overwhelmed by the demands of living with diabetes and about the extent that people believe that they are failing with their diabetes routine. Each item is evaluated using a 6-point scale (1 and 2 = not a problem, 3 and 4 = moderate problem, and 5 and 6 = serious problem) for a range of possible scores between 2 and 12. People who rate these two items higher are reporting a greater the degree to which diabetes-related distress is bothering them in their lives.

  5. Patient Health Questionnaire (PHQ-4) [ Time Frame: baseline, 3 months, 6 months ]
    PHQ-4 is an 4-item instrument that is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies, and also serves as a useful measure for the purpose of population-based studies. A score of 10 or greater is considered major depression, 20 or more is severe major depression.

  6. Diabetes Empowerment Scale - Short Form (DES-SF) [ Time Frame: baseline, 3 months, 6 months ]

    The DES-SF is an 8-item short form of the original 37-item Diabetes Empowerment Scale. The DES-SF allows for a brief overall assessment of diabetes-related psychosocial self-efficacy. Investigations have provided preliminary evidence that the DES-SF is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy.

    An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point. The possible range of scores is 8-40, with higher scores indicating higher diabetes-related psychosocial self-efficacy.


  7. Brief Illness Perception Questionnaire (Brief IPQ) [ Time Frame: baseline, 3 months, 6 months ]

    The Brief IPQ is a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. The Brief IPQ uses a single-item scale approach to assess perception on a 0-10 continuous linear response scale. Overall, the Brief IPQ is a psychometrically sound instrument that provides a rapid assessment of illness perceptions, and can be particularly helpful in ill populations, large-scale studies, and in repeated measures research designs.

    To compute the score, reverse score items 3, 4, and 7 and add these to items 1, 2, 5, 6, and 8 for a range of scores from 0-80. A higher score reflects a more threatening view of the illness. Item 9 is qualitative and not scored with the other items. It asks respondents to list in rank-order the three most important factors they believe caused their illness.


  8. Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: baseline, 3 months, 6 months ]

    The BMQ is a tool for evaluating people's beliefs about the necessity of medications and concerns about using those medications. It has been validated for use in patients with chronic illnesses and has been shown to predict adherence to treatment among people with type 2 diabetes.

    The BMQ has 10-items and consists of two 5-item subscales: necessity beliefs and concern beliefs. Each item is measured on 5-point Likert-type scales with 'strongly disagree (score = 1)' to 'strongly agree (score = 5)' response options. The scores summed for each subscale range from 5-25, with a higher score meaning stronger necessity or concern beliefs about the medication prescribed for personal use.


  9. Newest Vital Sign (NVS) [ Time Frame: baseline, 3 months, 6 months ]
    The NVS is a 6-item assessment of respondent's health literacy in the following areas: literacy, comprehension, application/function, evaluation, and numeracy skills. Each question is scored "0" for incorrect and "1" for correct yielding a total score ranging from 0 to 6, with higher scores indicating better health literacy. Scores of less than 2 represents high likelihood (50% or more) of limited (inadequate) literacy, 2 to 3 indicates possibility of limited (marginal) literacy, and more than 3 suggests adequate literacy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Shared Inclusion Criteria for Ambassadors and Buddies:

  • Self-identify as AA
  • Can speak/read English
  • Self-report being prescribed one oral or injectable diabetes medication
  • Access to/can use a cellular phone, tablet or computer to join a web-based meeting by video camera during the study period
  • Diagnosed with diabetes for ≥1 year (obtained by self-report or verified by electronic medical record)
  • Will reside in the geographical area throughout the study period

Inclusion Criteria Specific to Buddies:

  • Self-reported nonadherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale
  • Most recent A1c is ≥8% based on information collected at point of care A1c testing

Inclusion Criteria Specific to Ambassadors:

  • Self-reported adherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale
  • Most recent A1c is <8% based on point of care A1c test
  • Willing to provide support to a Buddy and track phone conversations
  • Willing to attend all training sessions and meetings related to being an Ambassador

Shared Exclusion Criteria for Ambassadors and Buddies:

  • Diagnosed psychiatric disorder
  • Older than 65-years old with a history of severe hypoglycemia requiring medical assistance or glucagon administration

Exclusion Criteria Specific to Buddies:

  • Currently participating in another diabetes lifestyle self-management or medication adherence program

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): NCT04857411


Contacts
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Contact: Martha Maurer, MPH, PhD 608-265-2662 mamaurer@wisc.edu

Locations
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United States, Wisconsin
Community Locations Recruiting
Milwaukee, Wisconsin, United States, 53202
Contact: Martha Maurer    608-265-2662    mamaurer@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Olayinka Shiyanbola, PhD, B.Pharm University of Wisconsin, Madison
Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04857411    
Other Study ID Numbers: 2020-1061
A561000 ( Other Identifier: UW Madison )
PHARM/PHARMACY ( Other Identifier: UW Madison )
Protocol Version 2/24/2021 ( Other Identifier: UW Madison )
Baldwin Grant ( Other Identifier: UW Office of the Provost )
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 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
Keywords provided by University of Wisconsin, Madison:
Medication adherence
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases