Empathy in Action: Sunshine Calls for Life With Diabetes

University of Texas at Austin260 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

260

Conditions

Diabetes Mellitus, Type 2 Diabetes Mental Health Health Behavior

Interventions

Empathy in Action for life with diabetes.BEHAVIORAL

In Phase 1 (Months 1-6) participants receive ("Program"): 1. 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. 2. 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. 3. 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 OnlyBEHAVIORAL

1. 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 2. 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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (9)

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

Outcomes

Primary Outcomes

Hemoglobin A1C (HbA1c)

Finger stick point-of-care portable device

Time frame: 6 months

Secondary Outcomes

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).

Time frame: 6 months

Diastolic and systolic blood pressure (mmHg)

Direct measurement with automatic blood pressure cuff

Time frame: 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).

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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