Acceptance Based Coping Skills for Diabetes Delivered By Promotores

NCT06445725 | Completed

• 2 other identifiers: H-543177K23DK123398
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

community health worker; acceptance and commitment therapy; task shifting; access to care

Outcome Measures

Primary Outcomes (2)

• Average blood glucose management (HbA1c)

  Glycated hemoglobin (HbA1c) is the average blood glucose levels in past 3 months (HbA1c); higher percentages reflect higher levels of blood glucose (worse blood glucose management).

  0, 24 weeks

• Quality of life: Patient Reported Outcomes Measurement Information System Global-10

  PROMIS-10 consists of 10 items that assess physical and mental health, functioning, emotional distress, interference, overall quality of life. There are two subscales - Global Physical Health and Global Mental Health. The raw score range for both subscales is 4 to 20, but raw scores are converted to T-scores with a range of 20-80. Higher scores indicate better health. Strong psychometrics.

  0, 6, 10, 24 weeks

Secondary Outcomes (5)

• Diabetes Acceptance: Acceptance & Action Diabetes Questionnaire (AADQ)

  0, 6, 10, 24 weeks

• Diabetes Acceptance: Diabetes Acceptance Scale (DAS)

  0, 6, 10, 24 weeks

• Self-management: Summary of Diabetes Self-Care Activities

  0, 6, 10, 24 weeks

• Diabetes Distress: Diabetes Distress Scale

  0, 6, 10, 24 weeks

• Emotional Distress: Patient Health Questionnaire-4

  0, 6, 10, 24 weeks

Other Outcomes (4)

• Feasibility: Recruitment

  24 weeks

• Feasibility: Retention

  24 weeks

• Acceptability: Interviews

  10 weeks

Study Arms (1)

Acceptance Based Coping (ABaCo) Skills Training

EXPERIMENTAL

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).

Behavioral: Acceptance Based Coping (ABaCo)

Interventions

Acceptance Based Coping (ABaCo) BEHAVIORAL

The educational ABaCo protocol consists of core Acceptance \& Commitment Therapy (ACT) interventions, culturally and contextually-tailored for this population, and in accordance with clinician-led versions of ACT for diabetes to include (a) identification of patient values, (b) teaching acceptance and brief mindfulness skills, and (c) techniques for engaging in valued activities while coping with difficult experiences (e.g., sugar cravings, distress). It is delivered by a community health worker (promotor/a) over 6 consecutive weeks over the phone, followed by a booster call at week 10.

Acceptance Based Coping (ABaCo) Skills Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The University of Texas Health Science Center at San Antonio: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (5)

• Gregg JA, Callaghan GM, Hayes SC, Glenn-Lawson JL. Improving diabetes self-management through acceptance, mindfulness, and values: a randomized controlled trial. J Consult Clin Psychol. 2007 Apr;75(2):336-43. doi: 10.1037/0022-006X.75.2.336.

  PMID: 17469891 BACKGROUND

• Schmitt A, Reimer A, Kulzer B, Icks A, Paust R, Roelver KM, Kaltheuner M, Ehrmann D, Krichbaum M, Haak T, Hermanns N. Measurement of psychological adjustment to diabetes with the diabetes acceptance scale. J Diabetes Complications. 2018 Apr;32(4):384-392. doi: 10.1016/j.jdiacomp.2018.01.005. Epub 2018 Jan 31.

  PMID: 29439862 BACKGROUND

• Barnett ML, Lau AS, Miranda J. Lay Health Worker Involvement in Evidence-Based Treatment Delivery: A Conceptual Model to Address Disparities in Care. Annu Rev Clin Psychol. 2018 May 7;14:185-208. doi: 10.1146/annurev-clinpsy-050817-084825. Epub 2018 Jan 31.

  PMID: 29401043 BACKGROUND

• Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.

  PMID: 32175717 BACKGROUND

• American Diabetes Association. Standards of Medical Care in Diabetes-2018 Abridged for Primary Care Providers. Clin Diabetes. 2018 Jan;36(1):14-37. doi: 10.2337/cd17-0119. No abstract available.

  PMID: 29382975 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kathryn Kanzler, PsyD ABPP

  Baylor College of Medicine; UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: single arm, pre-post, mixed-methods pilot study

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: June 6, 2024
• Study Start: March 4, 2024
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after the publication of primary outcomes
• Access Criteria: Email request to PI (Dr. Kanzler, kathryn.kanzler@bcm.edu) , who will share in accordance with institutional policies.

Locations

US (1)