Acceptance Based Coping (ABaCo) Skills Delivered By Promotores for Hispanic/Latino Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Average blood glucose management (HbA1c)
研究概览
简要总结
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:
- What is the impact of the ABaCo program on participants' blood sugar management and quality of life?
- How well are we able to enroll participants and keep them in the ABaCo program?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •A medical condition or life circumstance that would contraindicate participation
- •Inability to read/comprehend the informed consent process or study instructions
研究组 & 干预措施
Acceptance Based Coping (ABaCo) Skills Training
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).
干预措施: Acceptance Based Coping (ABaCo) (Behavioral)
结局指标
主要结局
Average blood glucose management (HbA1c)
时间窗: 0, 24 weeks
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).
Quality of life: Patient Reported Outcomes Measurement Information System Global-10
时间窗: 0, 6, 10, 24 weeks
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.
次要结局
- Self-management: Summary of Diabetes Self-Care Activities(0, 6, 10, 24 weeks)
- Diabetes Acceptance: Acceptance & Action Diabetes Questionnaire (AADQ)(0, 6, 10, 24 weeks)
- Diabetes Acceptance: Diabetes Acceptance Scale (DAS)(0, 6, 10, 24 weeks)
- Emotional Distress: Patient Health Questionnaire-4(0, 6, 10, 24 weeks)
- Diabetes Distress: Diabetes Distress Scale(0, 6, 10, 24 weeks)
研究者
Kathryn E. Kanzler
Associate Professor
Baylor College of Medicine