Empathy in Action: Sunshine Calls for Life With Diabetes

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT05173675

Run by

University of Texas at Austin

People needed

260

Starts

2022-02-12

Expected to finish

2024-04-29

Last updated by the study team

2024-05-07

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Lone Star Circle of Care at Ben White Health Clinic — Austin, Texas, United States
• Lone Star Circle of Care at El Buen Samaritano — 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 Bastrop — Bastrop, Texas, United States
• Lone Star Circle of Care at Cedar Park — Cedar Park, Texas, United States
• Lone Star Circle of Care at Lake Aire Medical Center — Georgetown, Texas, United States
• Lone Star Circle of Care at Pflugerville — Pflugerville, Texas, United States
• Lone Star Circle of Care at Texas A&M Health Science Center — Round Rock, Texas, United States

Full record on ClinicalTrials.gov

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