Acceptance-Based Coping Skills for Type 2 Diabetes

(ABaCo Trial)

Overseen By Olivia Morris

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Medical condition, Life circumstance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 10 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Kathryn Kanzler, PsyD ABPP

Principal Investigator

Baylor College of Medicine; UT Health San Antonio

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino patients with type 2 diabetes. Participants will engage in a program delivered by community health workers over the phone, aimed at improving blood sugar management and quality of life. They must be willing to provide blood samples, answer questionnaires, and commit to weekly calls plus a follow-up.

Inclusion Criteria

My HbA1c level is 7.5% or higher and I may be on medication for type 2 diabetes.

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

Exclusion Criteria

A medical condition or life circumstance that would contraindicate participation

Inability to read/comprehend the informed consent process or study instructions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 phone visit

Treatment

Participants receive the ABaCo program through seven individual phone call visits with promotores over 6 weeks, followed by a booster session at week 10.

10 weeks

7 phone visits (weekly for 6 weeks), 1 booster phone visit at week 10

Follow-up

Participants are monitored for safety and effectiveness after treatment, including final assessments at 24 weeks.

14 weeks

1 in-person visit at 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance Based Coping (ABaCo)

Trial Overview The ABaCo (Acceptance Based Coping) program is being tested for its effectiveness when taught by promotores via phone calls. The study checks if this method helps patients manage their diabetes better and enhances their overall well-being.

How Is the Trial Designed?

Group I: Acceptance Based Coping (ABaCo) Skills Training Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+