Acceptance Based Coping Skills for Diabetes Delivered By Promotores — ABaCo  

Type 2 Diabetes Clinical Trial

Official title: Acceptance Based Coping (ABaCo) Skills Delivered By Promotores for Hispanic/Latino Patients With Type 2 Diabetes

Status Recruiting

Clinical Trial Summary

The goal of this pilot clinical trial is to learn about the feasibility and acceptability of promotores (community health workers) delivering an educational intervention for Hispanic/Latino patients with type 2 diabetes.

The main questions it aims to answer are:

1. What is the impact of the ABaCo program on participants' blood sugar management and quality of life?

2. How well are we able to enroll participants and keep them in the ABaCo program?

3. Is this telephone-based, educational ABaCo program acceptable?

Participants will be asked to:

• Participate in four research visits: provide fingerstick blood samples before and after the program (at 6 months), and complete questionnaires at four times times during the program (before, twice during, and at 6 months).

• Participate in the ABaCo program: join seven (7) individual phone call visits with promotores to review educational information about caring for diabetes while keeping connected to life values. Each phone call lasts approximately 45 minutes once per week for six (6) weeks, then a refresher visit is a month later.

Clinical Trial Description

This overall project aims to develop an acceptable and feasible Promotores-delivered intervention program for Hispanic/Latino patients with type 2 diabetes. Specifically, this study aims to conduct a mixed-methods, single arm pre-post intervention pilot trial (6 months) on the Acceptance Based Coping (ABaCo) program to

• Evaluate feasibility (recruitment and retention) and acceptability (satisfaction)

• Establish methods of assessing intervention fidelity

• Engage multi-level partners

• Estimate the magnitude of potential impact of ABaCo on selected mechanisms and outcomes.

Hypothesis: Participants receiving ABaCo will evidence clinically meaningful change from baseline to follow-up on glycemic management and quality of life (primary outcomes) and self-management skills and acceptance coping (secondary outcomes).

Procedures: Potential participants will be referred to study staff by the Promotores team at the University Health Robert B Green Campus Family Health Center. They will be contacted by study staff for a phone visit to conduct screening procedures. If eligible, they will be scheduled for an in-person visit at the Texas Diabetes Institute (TDI), where they will be consented, complete a fingerstick HbA1c test, and complete an initial assessment packet. Participants will then receive the intervention (telephone-delivered ABaCo skills program) delivered by one Promotor/a for 6 weeks and again at week 10 (booster visit). There will be phone-based assessments visit at week 6, and again at week 10. They will be invited to participate in an interview to provide feedback on their experiences in the program and study. A final in-person assessment at TDI will be conducted at 24 weeks (6 months) after baseline, including a fingerstick HbA1c test and a final assessment packet.

At the study conclusion, all engaged Promotores and clinical partners will also be invited to share their experiences via written and verbal feedback. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT06445725
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Olivia Morris
• Phone: 713-440-0345
• Email: olivia.morris@bcm.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Completion date: October 31, 2024