Clinical trial NCT04857411: Peers LEAD Plus Healthy Living With Diabetes (HLWD)
Official title: Improving Diabetes Programs for Blacks in Wisconsin: Peers as Coaches in Medicine Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Medication adherence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This project represents the next phase of prior work at the University of Wisconsin School of Pharmacy to create and implement community-based programs for AAs with diabetes that focus on improving medication use and glycemic control. The overall objective is to integrate Peers LEAD into HLWD using a community-engaged approach and an evaluation to document outcomes. This project will produce a culturally-tailored curriculum that can be used broadly across social service and community organizations, faith-based organizations, and federally-qualified health centers committed to improving AAs diabetes self-management. This project will be achieved through the following objectives:

* Objective 1: To gather and incorporate key stakeholders input in the current and future adoption of Peers LEAD+HLWD into community organizations, health system and/or practices. Objective 1 is not a clinical trial.
* Objective 2: To implement and measure the outcomes of Peers LEAD+HLWD to improve medication adherence and hemoglobin A1c. Objective 2 represents the clinical trial aim of this study to be registered in this record.

HLWD is a successful community-based program that offers tools and resources to enhance understanding of what it means to have diabetes, including helping participants to build the confidence to manage diabetes and maintain an active and fulfilling life. HLWD is endorsed by the American Diabetes Association and the Centers for Disease Prevention and Control and proven to reduce emergency department visits by 53%, improve A1c levels, enhance regular treatment and diabetes education, create a community-clinical link in care, provide social benefits for participants, improve self-rated health and communication with physicians, and improve health status, health behavior, and self-efficacy. The investigators chose HLWD as the diabetes self-management education (DSME) program to adapt because it is an effective and widely-disseminated evidence-based DSME program. HLWD has enrolled over 5,000 participants in more than 400 workshops across 52 Wisconsin counties. However, between 2013 and 2016, only 120 AAs (3.1%) participated compared to 1,656 non-Hispanic Whites. In 3 years, only 46% of AAs reported that they took their diabetes pills (HLWD's measure of medication adherence) after the workshop, compared to 55% of non-Hispanic Whites. Despite HLWD's positive outcomes and wide reach, there is limited inclusion of AAs. HLWD does not offer culturally-tailored content for AAs, and lacks one-on-one peer support from an AA who successfully manages diabetes, an important factor influential in improving diabetes outcomes among AAs. There is also insufficient attention to medication adherence. Adding Peers LEAD to HLWD will improve the reach, effectiveness, and impact of diabetes self-management programs among AAs.

Peers LEAD is a culturally-tailored program designed to provide AAs with diabetes and medication beliefs information, behavioral skill-development, and one-on-one peer support to increase medication adherence. Group sessions include discussions of personal discrimination experiences that resulted in provider mistrust, making the most of clinic/pharmacy visits, necessity and concerns about medicines, and enhancing patient-provider communication. Ambassadors are paired with Buddies, and Ambassadors help deliver Peers LEAD content via face-to-face interaction with their Buddies during group sessions and phone follow-ups. Ambassadors address misperceptions of medicines and diabetes, share their experiences managing diabetes and medicines, and discuss building relationships with providers. As well, they are able to provide one-on-one social support.

Peers LEAD+HLWD allows for sufficient attention to medication adherence in a DSME program. For example, HLWD includes only one 20-minute activity on medication use in a 2½ hour session during Week 5. This activity only covers purpose of medicines, medication effects, and remembering to take medicines, but does not address known specific barriers to AAs adherence. In this study, HLWD will be adapted for AAs by adding components of Peers LEAD to overcome key barriers to AAs medication adherence. Core components of Peers LEAD to be incorporated are two group sessions on beliefs about medicines and diabetes, discrimination/mistrust, and provider communication, as well as peer-based phone support from Ambassadors.

The investigators hypothesize that, by implementing Peers LEAD+HLWD, there will be increased reach, engagement, and impact for AAs because psychosocial/sociocultural factors and barriers identified in their work to influence AAs medication adherence (i.e., culturally embedded health beliefs and provider mistrust) will be addressed.

Objective 2 is a pre-post single group design to conduct Peers LEAD+HLWD in Milwaukee. There will be two groups of participants: (1) Ambassadors (who are not consented into the intervention, but help facilitate it) - AAs who have diabetes and are adherent with their medicines and (2) Buddies (consented into the intervention) - who are AAs who have diabetes but are nonadherent with their medicines.

Training of Ambassadors: To prepare to implement Peers LEAD+HLWD, Ambassadors will attend a 6-hour orientation and training meetings, co-facilitated by Wisconsin Network for Research Support (WINRS). This meeting will be an orientation and will prepare the Ambassadors to implement specific elements of Peers LEAD+HLWD, such as the phone calls. WINRS will consult with the research team on all meetings. For \>8 years, WINRS staff have been deeply involved in stakeholder engagement, as well as trained, planned and facilitated \>250 lay advisory board meetings.

Ambassadors are involved in two group sessions focusing on beliefs about medicines and diabetes, discrimination/mistrust, and communication with providers, and peer-based phone support with buddies to occur weekly for the first 2 weeks, then for 5 weeks after the completion of the 8-week program. Building on the previously piloted version of Peers LEAD, Peers LEAD + HLWD has added phone-based peer support from Ambassadors comprised of bi-weekly calls to monitor progress toward goals (Month 4) and finally monthly calls to support goal adherence (Months 5-6), representing the Maintenance Phase.

Eligibility 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

Primary outcomes:
measure: Mean Hemoglobin A1c
timeFrame: baseline
measure: Mean Hemoglobin A1c
timeFrame: 3 months
measure: Mean Hemoglobin A1c
timeFrame: 6 months
measure: Mean Systolic Blood Pressure
timeFrame: baseline
measure: Mean Systolic Blood Pressure
timeFrame: 3 months
measure: Mean Systolic Blood Pressure
timeFrame: 6 months
measure: Change in Diastolic Blood Pressure
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Adherence to Reﬁlls and Medications Scale for Diabetes (ARMS-D) Score
timeFrame: baseline, 3 months, 6 months
measure: Self-Efficacy for Adherence to Medication Use Scale (SEAMS)
timeFrame: baseline, 3 months, 6 months
measure: Patient's Perceived Involvement in Care Scale (PICS)
timeFrame: baseline, 3 months, 6 months
measure: Diabetes Distress Scale (DDS) 2
timeFrame: baseline, 3 months, 6 months
measure: Patient Health Questionnaire (PHQ-4)
timeFrame: baseline, 3 months, 6 months
measure: Diabetes Empowerment Scale - Short Form (DES-SF)
timeFrame: baseline, 3 months, 6 months
measure: Brief Illness Perception Questionnaire (Brief IPQ)
timeFrame: baseline, 3 months, 6 months
measure: Beliefs about Medicines Questionnaire (BMQ)
timeFrame: baseline, 3 months, 6 months
measure: Newest Vital Sign (NVS)
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Community Locations
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Olayinka Shiyanbola, PhD, B.Pharm
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shiyanbola OO, Maurer M, Schwerer L, Sarkarati N, Wen MJ, Salihu EY, Nordin J, Xiong P, Egbujor UM, Williams SD. A Culturally Tailored Diabetes Self-Management Intervention Incorporating Race-Congruent Peer Support to Address Beliefs, Medication Adherence and Diabetes Control in African Americans: A Pilot Feasibility Study. Patient Prefer Adherence. 2022 Oct 25;16:2893-2912. doi: 10.2147/PPA.S384974. eCollection 2022.