NCT05173675Completed
Empathy in Action: Sunshine Calls for Life With Diabetes
Source: ClinicalTrials.gov · Last updated 7 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 2 Dec 2021
- Start date
- 12 Feb 2022
- Primary completion date
- 20 Nov 2023
- Lead sponsor
- University of Texas at Austin
- Diseases
- Type 2 diabetes
- NCT number
- NCT05173675
What you commit to
- Study type: Interventional
- Participants enrolled: 260
- From 12 Feb 2022 to the primary completion date, 20 Nov 2023
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving systemic treatment with prednisone or immunosuppressant therapy following an organ transplant
Other illness
- Moderate to severe cognitive impairment
- Undergoing cancer treatment
- Having diagnosis of end-stage renal disease or serious mental illness
- Having moderate to severe cognitive impairment
Lab values
- HbA1c \< 7.5% at baseline measurement.
Other
- Refusal to answer the PHQ-9 form in its entirety at baseline data collection.
- Currently pregnant (if of female sex)
Who the study is looking for
- 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).
Age in the registry: 21 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lone Star Circle of Care at El Buen Samaritano Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Lone Star Circle of Care at Northwest Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Lone Star Circle of Care at Collinfield Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Lone Star Circle of Care at Ben White Health Clinic Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Lone Star Circle of Care at Bastrop Coordinator of this site? Confirm its status | Bastrop | United States | Unknown status |
| Lone Star Circle of Care at Cedar Park Coordinator of this site? Confirm its status | Cedar Park | United States | Unknown status |
| Lone Star Circle of Care at Lake Aire Medical Center Coordinator of this site? Confirm its status | Georgetown | United States | Unknown status |
| Lone Star Circle of Care at Pflugerville Coordinator of this site? Confirm its status | Pflugerville | United States | Unknown status |
| Lone Star Circle of Care at Texas A&M Health Science Center Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.