Clinical trial NCT05173675: Empathy in Action: Sunshine Calls for Life With Diabetes
Official title: Empathy in Action: Sunshine Calls for Life With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes
Mental Health
Health Behavior
Keywords: Telephone
Empathy
Layperson
Self-Management
Incentives
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Lone Star Circle of Care
First posted: 2021-12-30
Enrollment: 260
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, stratified by PHQ-9 baseline scores (cut-off ≥5), on a 1:1 ratio
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1C (HbA1c)
timeFrame: 6 months
Secondary outcomes:
measure: Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: 6 months
measure: Diastolic and systolic blood pressure (mmHg)
timeFrame: 6 months
measure: Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: 6 months
measure: General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12)
timeFrame: 6 months
measure: Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5)
timeFrame: 6 months
measure: Perceived Diabetes Self-Management Scale (PDSMS)
timeFrame: 6 months
measure: Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
timeFrame: 6 months
measure: Loneliness measured by scores on the 3-item UCLA Loneliness Scale
timeFrame: 6 months
measure: Diabetes distress measured by the 2-item Diabetes Distress Screening Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Lone Star Circle of Care at Ben White Health Clinic
state: Texas
city: Austin
country: United States
facility: Lone Star Circle of Care at El Buen Samaritano
state: Texas
city: Austin
country: United States
facility: Lone Star Circle of Care at Collinfield
state: Texas
city: Austin
country: United States
facility: Lone Star Circle of Care at Northwest Austin
state: Texas
city: Bastrop
country: United States
facility: Lone Star Circle of Care at Bastrop
state: Texas
city: Cedar Park
country: United States
facility: Lone Star Circle of Care at Cedar Park
state: Texas
city: Georgetown
country: United States
facility: Lone Star Circle of Care at Lake Aire Medical Center
state: Texas
city: Pflugerville
country: United States
facility: Lone Star Circle of Care at Pflugerville
state: Texas
city: Round Rock
country: United States
facility: Lone Star Circle of Care at Texas A&M Health Science Center
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Maninder Kahlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: