Empathy in Action: Sunshine Calls for Life With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— EIA-Diabetes  

Official title:

Empathy in Action: Sunshine Calls for Life With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173675
• Other study ID #: STUDY00001571
• Status: Completed
• Phase: N/A
• Start date: February 12, 2022
• Est. completion date: April 29, 2024

Study information

• Verified date: May 2024
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 29, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Empathy in Action for life with diabetes.
In Phase 1 (Months 1-6) participants receive ("Program"): 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. 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. Educational Materials: Printed DM management educational materials mailed right after enrollment and randomization, and expected to be received in weeks 1-2.
• Control Phase 2 Materials Only
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 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

Locations

Country	Name	City	State
United States	Lone Star Circle of Care at Ben White Health Clinic	Austin	Texas
United States	Lone Star Circle of Care at Collinfield	Austin	Texas
United States	Lone Star Circle of Care at El Buen Samaritano	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Lone Star Circle of Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C (HbA1c)	Finger stick point-of-care portable device	6 months
Secondary	Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)	Self-administered. Based on the nine DSM-V criteria listed under criterion A for Major Depressive Disorder. Responders are asked to rate the frequency of depression symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (Nearly every day). Items are summed to provide a total score (0-27). The total score serves as a marker of severity and distress (5-9 minimal depressive symptoms; 10-14 minor depression or dysthymia; 15-27 major depressive symptoms).	6 months
Secondary	Diastolic and systolic blood pressure (mmHg)	Direct measurement with automatic blood pressure cuff	6 months
Secondary	Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)	Self-administered. Based on some of the DSM-V criteria for General Anxiety Disorder to identify probable cases of GAD along with measuring anxiety symptom severity. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0 (not at all) to 3 (nearly every day). Items are summed to provide a total score (0-21) to inform severity (1-4 minimal symptoms; 5-9 mild symptoms; 10-14 moderate symptoms; 15-21 severe symptoms).	6 months
Secondary	General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12)	Self-administered. Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.	6 months
Secondary	Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5)	Self-administered. It asks respondents to rate the frequency with which the five different medication-taking behaviors occur. Each items is scored on a five-point scale (5 = never, 4 = rarely, 3 = sometimes, 2 = often, 1 = very often), with higher scores indicating higher reported adherence.	6 months
Secondary	Perceived Diabetes Self-Management Scale (PDSMS)	Self-administered. The responses for the 8 items PDSMS items range from 1 = "Strongly Disagree" to 5 = "Strongly Agree." The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.	6 months
Secondary	Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item	Self-Administered. Respondents are asked to score their level of confidence (scale from 1, not at all confident, to 10, totally confident) at the present time in doing tasks related to diabetes management (e.g., diet behavior, physical activity, measuring blood glycemia and others). Higher scores indicate higher self-efficacy.	6 months
Secondary	Loneliness measured by scores on the 3-item UCLA Loneliness Scale	Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.	6 months
Secondary	Diabetes distress measured by the 2-item Diabetes Distress Screening Scale	The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. Higher scores suggest higher diabetes distress.	6 months