Acceptance Based Coping Skills for Diabetes Delivered By Promotores (ABaCo)

Baylor College of Medicine

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Acceptance Based Coping (ABaCo)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06445725

7K23DK123398 (U.S. NIH Grant/Contract)

H-54317

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70
• Diagnosis of Type 2 Diabetes (T2DM)
• HbA1c of 7.5% or greater (may be taking oral agents or injectables for T2DM management)
• Evidence of avoidance coping (prescreen of <48.4 on English or a <52 on the Spanish Acceptance and Action Diabetes Questionnaire) and/or poor self-management skills (prescreen below recommended frequencies in 2 or more sub-scales of the Summary of Diabetes Self-Care Activities)
• Self-identifies as Hispanic/Latino
• Receiving ongoing care at study site clinic
• Preferred language is English or Spanish

Exclusion criteria

• A medical condition or life circumstance that would contraindicate participation
• Inability to read/comprehend the informed consent process or study instructions

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Acceptance Based Coping (ABaCo) Skills Training

Experimental group

Description:

Participant-patients will receive care as usual in the Nosotros Promotores program at University Health Robert B Green Campus Family Health Center, including standardized procedures (e.g., home visits, phone calls and in-clinic visits), along with this protocol - individual telephone-delivered ABaCo skills intervention delivered by one Promotor/a for 10 weeks (6 weeks plus booster at 10 weeks).

Treatment:

Behavioral: Acceptance Based Coping (ABaCo)