Empathy in Action: Sunshine Calls for Life With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 18
- 主要终点
- Hemoglobin A1C (HbA1c)
研究概览
简要总结
Randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a Federally Qualified Health Center (FQHC) against usual care.
详细描述
In this study, we will assess the effectiveness of a 6-month program delivered by phone by lightly-trained lay people to individuals with diabetes, with the goal of empathetic relationship building and engagement to support day-to-day challenges of managing diabetes and working towards self-management goals. We will recruit from a collaborating Federally Qualified Health Center (FQHC) and use a randomized controlled trial, comparing program to usual care. Telephone callers will be lay people (no formal health training) who will be recruited for authentic interest and empathetic skills and lightly trained on conversational skills, cultural nuances, and how best to support people's individual lifestyle goals on nutrition, exercise, sleep and medication adherence. Callers will encourage participants to seek additional help from their clinic or specific social services as needs arise that benefit from early escalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research staff responsible for biomedical data collection at the sites are blinded to the status of the participant as part of control or intervention group. Self-reported outcomes are reported by participants on a tablet.
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c ≥ 7.5% at baseline measurement and 8.0% at least one time 12 months prior to study enrollment.
- •At least one visit with Lone Star Circle of Care within the past 12 months (in person or telehealth)
- •Willing to answer the PHQ-9 form in its entirety at baseline data collection (due to stratified randomization design).
排除标准
- •HbA1c < 7.5% at baseline measurement.
- •Refusal to answer the PHQ-9 form in its entirety at baseline data collection.
- •Moderate to severe cognitive impairment
- •Currently pregnant (if of female sex)
- •Undergoing cancer treatment
- •Having diagnosis of end-stage renal disease or serious mental illness
- •Having moderate to severe cognitive impairment
- •Receiving systemic treatment with prednisone or immunosuppressant therapy following an organ transplant
结局指标
主要结局
Hemoglobin A1C (HbA1c)
时间窗: 6 months
Finger stick point-of-care portable device
次要结局
- Perceived Diabetes Self-Management Scale (PDSMS)(6 months)
- Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item(6 months)
- Diabetes distress measured by the 2-item Diabetes Distress Screening Scale(6 months)
- Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)(6 months)
- General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12)(6 months)
- Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5)(6 months)
- Diastolic and systolic blood pressure (mmHg)(6 months)
- Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)(6 months)
- Loneliness measured by scores on the 3-item UCLA Loneliness Scale(6 months)
研究者
Maninder Kahlon
Associate Professor
University of Texas at Austin