Acceptance Based Coping Skills for Diabetes Delivered By Promotores
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.
Conditions:
🦠 Type 2 Diabetes
🗓️ Study Start (Actual) 4 March 2024
🗓️ Primary Completion (Estimated) 31 October 2024
✅ Study Completion (Estimated) 31 October 2024
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Antonio, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 April 2024
  • First Submitted that Met QC Criteria 4 June 2024
  • First Posted 6 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 June 2024
  • Last Update Posted 6 June 2024
  • Last Verified June 2024