Empathy in Action: Sunshine Calls for Life With Diabetes (EIA-Diabetes)

The University of Texas System (UT)

Status: Completed

Conditions: Diabetes; Health Behavior; Diabetes Mellitus, Type 2; Mental Health

Treatments: Behavioral: Control Phase 2 Materials Only; Behavioral: Empathy in Action for life with diabetes.

Study type: Interventional

Funder types: Other

Identifiers

NCT05173675

STUDY00001571

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 2 patient groups

Program arm

Experimental group

Description:

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.

Treatment:

Behavioral: Empathy in Action for life with diabetes.

Control arm

Other group

Description:

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.

Treatment:

Behavioral: Control Phase 2 Materials Only