NCT05173675

Empathy in Action: Sunshine Calls for Life With Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Diabetes
• Mental Health
• Health Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Empathy in Action for life with diabetes.	In Phase 1 (Months 1-6) participants receive ("Program"): 1. Empathetic communications: A dedicated partner (lightly-trained lay person) who communicates with them via phone with timing and frequency defined by the participant within certain parameters. Two letters mailed during the 6 months that compile anonymized learnings from all participants in the callers panel of 10-20 participants, written as a newsletter to share back with the participant. 2. Material Incentives: One choice of health tool (weight scale or pedometer) selected with the caller in week 1 and expected to be received in weeks 3-5. Two small recognition gifts (valued at US$25) chosen by the caller based on their understanding of the participants preferences, and sent at month 2.5 and 4.5. 3. Educational Materials: Printed DM management educational materials mailed right after enrollment and randomization, and expected to be received in weeks 1-2.
BEHAVIORAL	Control Phase 2 Materials Only	1. Material Incentives: a. Choice of health tool (weight scale or pedometer) and 2 health promoting gifts chosen by the caller at the end of their 6 month measurement visit. i. Health tool is mailed out within the 7th month ii. Health promoting gifts are mailed out in the 8th and 10th month 2. Educational Materials a. The same educational materials mailed to participants in the intervention arm "Program" will be mailed to control arm participants after they complete their 6 months visit

Timeline

• Start date: 2022-02-12
• Primary completion: 2023-11-20
• Completion: 2024-04-29
• First posted: 2021-12-30
• Last updated: 2024-05-07

Locations

9 sites across 1 country: United States