Clinical trial NCT06445725: Acceptance Based Coping Skills for Diabetes Delivered By Promotores
Official title: Acceptance Based Coping (ABaCo) Skills Delivered By Promotores for Hispanic/Latino Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: community health worker
acceptance and commitment therapy
task shifting
access to care
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2024-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm, pre-post, mixed-methods pilot study
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average blood glucose management (HbA1c)
timeFrame: 0, 24 weeks
measure: Quality of life: Patient Reported Outcomes Measurement Information System Global-10
timeFrame: 0, 6, 10, 24 weeks
Secondary outcomes:
measure: Diabetes Acceptance: Acceptance & Action Diabetes Questionnaire (AADQ)
timeFrame: 0, 6, 10, 24 weeks
measure: Diabetes Acceptance: Diabetes Acceptance Scale (DAS)
timeFrame: 0, 6, 10, 24 weeks
measure: Self-management: Summary of Diabetes Self-Care Activities
timeFrame: 0, 6, 10, 24 weeks
measure: Diabetes Distress: Diabetes Distress Scale
timeFrame: 0, 6, 10, 24 weeks
measure: Emotional Distress: Patient Health Questionnaire-4
timeFrame: 0, 6, 10, 24 weeks
Other outcomes:
measure: Feasibility: Recruitment
timeFrame: 24 weeks
measure: Feasibility: Retention
timeFrame: 24 weeks
measure: Acceptability: Interviews
timeFrame: 10 weeks
measure: Acceptability: Ratings
timeFrame: 10 weeks
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Baylor College of Medicine; UT Health San Antonio
name: Kathryn Kanzler, PsyD ABPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.