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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes; Mental Health; Health Behavior
• Intervention / Treatment: Behavioral: Empathy in Action for life with diabetes.; Behavioral: Control Phase 2 Materials Only

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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78704
      • Lone Star Circle of Care at Ben White Health Clinic
    • Austin, Texas, United States, 78745
      • Lone Star Circle of Care at El Buen Samaritano
    • Austin, Texas, United States, 78758
      • Lone Star Circle of Care at Collinfield
    • Austin, Texas, United States, 78759
      • Lone Star Circle of Care at Northwest Austin
    • Bastrop, Texas, United States, 78602
      • Lone Star Circle of Care at Bastrop
    • Cedar Park, Texas, United States, 78613
      • Lone Star Circle of Care at Cedar Park
    • Georgetown, Texas, United States, 78628
      • Lone Star Circle of Care at Lake Aire Medical Center
    • Pflugerville, Texas, United States, 78660
      • Lone Star Circle of Care at Pflugerville
    • Round Rock, Texas, United States, 78665
      • Lone Star Circle of Care at Texas A&M Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Program arm; 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.	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.
Other: Control arm; 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.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C (HbA1c)	Finger stick point-of-care portable device	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Diastolic and systolic blood pressure (mmHg)	Direct measurement with automatic blood pressure cuff	6 months
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Lone Star Circle of Care
• Investigators: Principal Investigator: Maninder Kahlon, PhD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2022
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): April 29, 2024

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Self-Management; Telephone; Empathy; Incentives; Layperson
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00001571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No