Empathy in Action: Sunshine Calls for Life With Diabetes
- Conditions
- Diabetes Mellitus, Type 2DiabetesMental HealthHealth Behavior
- Interventions
- Behavioral: Empathy in Action for life with diabetes.Behavioral: Control Phase 2 Materials Only
- Registration Number
- NCT05173675
- Lead Sponsor
- University of Texas at Austin
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Program arm Empathy in Action for life with diabetes. Usual Care+ Phase 1 (6 months, months 1-6), Program. Includes empathetic communications (phone \& letter), health-promoting incentives, educational materials. Phase 2 (6 months, months 7-12) No Program. During this follow-up period they will receive monthly SMS texts with customized messages encouraging health promoting behaviors. Control arm Control Phase 2 Materials Only Usual Care+ Phase 1 (6 months, months 1-6), No Program. Phase 2 (6 months, months 7-12) Material components of program including health-promoting incentives and educational materials.
- Primary Outcome Measures
Name Time Method Hemoglobin A1C (HbA1c) 6 months Finger stick point-of-care portable device
- Secondary Outcome Measures
Name Time Method Perceived Diabetes Self-Management Scale (PDSMS) 6 months Self-administered. The responses for the 8 items PDSMS items range from 1 = "Strongly Disagree" to 5 = "Strongly Agree." The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.
Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item 6 months Self-Administered. Respondents are asked to score their level of confidence (scale from 1, not at all confident, to 10, totally confident) at the present time in doing tasks related to diabetes management (e.g., diet behavior, physical activity, measuring blood glycemia and others). Higher scores indicate higher self-efficacy.
Diabetes distress measured by the 2-item Diabetes Distress Screening Scale 6 months The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. Higher scores suggest higher diabetes distress.
Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9) 6 months Self-administered. Based on the nine DSM-V criteria listed under criterion A for Major Depressive Disorder. Responders are asked to rate the frequency of depression symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (Nearly every day). Items are summed to provide a total score (0-27). The total score serves as a marker of severity and distress (5-9 minimal depressive symptoms; 10-14 minor depression or dysthymia; 15-27 major depressive symptoms).
General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12) 6 months Self-administered. Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.
Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5) 6 months Self-administered. It asks respondents to rate the frequency with which the five different medication-taking behaviors occur. Each items is scored on a five-point scale (5 = never, 4 = rarely, 3 = sometimes, 2 = often, 1 = very often), with higher scores indicating higher reported adherence.
Diastolic and systolic blood pressure (mmHg) 6 months Direct measurement with automatic blood pressure cuff
Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7) 6 months Self-administered. Based on some of the DSM-V criteria for General Anxiety Disorder to identify probable cases of GAD along with measuring anxiety symptom severity. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed to provide a total score (0-21) to inform severity (1-4 minimal symptoms; 5-9 mild symptoms; 10-14 moderate symptoms; 15-21 severe symptoms).
Loneliness measured by scores on the 3-item UCLA Loneliness Scale 6 months Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.
Trial Locations
- Locations (9)
Lone Star Circle of Care at Bastrop
🇺🇸Bastrop, Texas, United States
Lone Star Circle of Care at Lake Aire Medical Center
🇺🇸Georgetown, Texas, United States
Lone Star Circle of Care at Cedar Park
🇺🇸Cedar Park, Texas, United States
Lone Star Circle of Care at Pflugerville
🇺🇸Pflugerville, Texas, United States
Lone Star Circle of Care at Ben White Health Clinic
🇺🇸Austin, Texas, United States
Lone Star Circle of Care at Collinfield
🇺🇸Austin, Texas, United States
Lone Star Circle of Care at Northwest Austin
🇺🇸Austin, Texas, United States
Lone Star Circle of Care at Texas A&M Health Science Center
🇺🇸Round Rock, Texas, United States
Lone Star Circle of Care at El Buen Samaritano
🇺🇸Austin, Texas, United States