Improving Diabetes Medication Adherence for African Americans in Madison and Milwaukee Through Peer Support

NCT04028076 | Completed

• 4 other identifiers: 2019-0721A561000PHARM/PHARMACYProtocol Version 6/7/2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The burden of diabetes is higher among African Americans (AAs) in Wisconsin as hospitalization rates for diabetes complications such as stroke and amputations are four times higher than whites and has worsened by 334% since 2011. The most important self-management behavior for improving diabetes outcomes is medication adherence, i.e., taking medicines as recommended by providers. Poor adherence to diabetes medications is common among AAs and contributes to disproportionally worse outcomes. While the reasons for nonadherence are multifactorial, health beliefs, lack of self-efficacy, social support, and limited health literacy, are critical factors for AAs. Due to discrimination experiences and provider distrust, AAs may have health beliefs that do not align with biomedicine. Existing adherence interventions designed for general populations may be ineffective for AAs because they do not adequately address these fundamental factors. The intervention is peer-led, such that AAs who have diabetes and are adherent to their medicines (Peer Ambassadors- (PAs)) are paired with AAs who have diabetes and are nonadherent (Peer Buddies- PBs)).Throughout the 8-week program, PAs actively support and teach PBs about self-advocacy in patient-provider relationships, as well as sharing their experiences managing diabetes, providing social support, enhancing health literacy, patient activation (engagement and empowerment) and self-efficacy. PAs help deliver the intervention via initial face-to-face and phone/app follow-ups with PBs, in addition to structured group education delivered to PBs by a physician, pharmacist, and diabetes educator separately. The investigator's aim is to use a community-engaged design to pilot the intervention, assessing the feasibility of gathering pre/post outcomes including culturally-informed diabetes-health beliefs, self-efficacy, patient activation, medication adherence (using surveys), and A1c, and further refine the intervention via feedback from an advisory board comprised of the PAs. The investigators hypothesize that the intervention will be feasible for AAs with diabetes. This study uses a collaborative approach involving patient stakeholders throughout the research process by directly engaging AAs with diabetes to utilize their experience, knowledge and advice. This project advances the development of culturally-appropriate medication adherence interventions for AAs with diabetes.

Conditions

Type2 Diabetes; Medication Adherence; Medication Nonadherence; Peer Support

Keywords

Peer Support; Type2 Diabetes; African American

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

  A study team researcher with clinical experience will perform a finger prick test to collect a small amount of blood to test for hemoglobin A1C. A glucometer will be used to measure the specimen's A1c level. The research team will promptly report all A1c levels to the participant by handwriting the result on a paper.

  Peer Buddy's Change in Hemoglobin A1c will be measured from baseline (prior to the intervention) at 3 months

Secondary Outcomes (5)

• Beliefs about Medicines Questionnaire

  Peer Buddies will complete a 20-minute paper survey prior to the intervention and up to 12 weeks later.

• Culturally adapted illness perception questionnaire

  Peer Buddies will complete a 20-minute paper survey prior to the intervention and up to 12 weeks later.

• Self-Efficacy for Appropriate Medication Use Scale (SEAMS)

  Peer Buddies will complete a 20-minute paper survey prior to the intervention and up to 12 weeks later.

• Newest Vital Sign

  Peer Buddies will complete a 20-minute paper survey prior to the intervention and up to 12 weeks later.

• Adherence to Refills and Medications Scale for Diabetes (ARMS-D)

  Peer Buddies will complete a 20-minute paper survey prior to the intervention and up to 12 weeks later.

Study Arms (1)

Peers LEAD

EXPERIMENTAL

8-week educational behavioral intervention

Behavioral: Peers Supporting Health-Literacy, Self Efficacy, Advocacy and Adherence

Interventions

Peers Supporting Health-Literacy, Self Efficacy, Advocacy and Adherence BEHAVIORAL

An 8-week culturally appropriate educational behavioral intervention that consists of structured group diabetes education and follow-up peer support with PAs. There will be 3 separate group education sessions led by a physician, AA pharmacist and AA diabetes educator. All PAs will attend each group session to learn together with their PBs and build social interactions. Weeks 1 and 2 consist of 2-hour group education between the participants and diabetes educator, and participants and pharmacist, respectively. Pre-test intervention data including A1c will be collected in Week 1. In Weeks 3-7, PAs will deliver the intervention content to PBs over the phone as well as help them set a goal towards getting healthy. An existing video/text messaging app, called WhatsApp® will be offered as an option to use to further enhance PA-PB interaction.

Also known as: Peers LEAD

Peers LEAD

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peer Ambassadors:
• Men and women 30-65 years old with type 2 diabetes who self-identify as Black/AA and can speak/read English at a 6th grade level,
• Self-report as prescribed one oral diabetes medication and are adherent to taking it (11 on the ARMS-D scale),
• Have access to/can use a phone with cellular/internet use during the study.
• Peer Buddies:
• Men and women 30-65 years old with type 2 diabetes who self-identify as Black/AA and can speak/read English at a 6th grade level,
• Self-report as prescribed one oral diabetes medication and are non-adherent to taking it (greater than 11 on the ARMS-D scale)
• Have access to/can use a phone with cellular/internet use during the study.

You may not qualify if:

• Peer Ambassadors:
• Individuals who are only using insulin (adherence may differ for these individuals)
• Individuals who report diagnosis of mental illness/psychosis.
• Peer Buddies:
• Individuals who are only using insulin (adherence may differ for these individuals),
• Individuals who have a diagnosed psychiatric disorder

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

• Shiyanbola OO, Maurer M, Mott M, Schwerer L, Sarkarati N, Sharp LK, Ward E. A feasibility pilot trial of a peer-support educational behavioral intervention to improve diabetes medication adherence in African Americans. Pilot Feasibility Stud. 2022 Nov 14;8(1):240. doi: 10.1186/s40814-022-01198-7.

  PMID: 36376960 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Olayinka Shiyanbola, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 22, 2019
• Study Start: July 10, 2019
• Primary Completion: October 5, 2020
• Study Completion: October 5, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)