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NCT Number: NCT05173675

Empathy in Action: Sunshine Calls for Life With 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Mental Health Metabolic Diseases Nutritional and Metabolic Diseases Personal Satisfaction Psychological Well-Being

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lone Star Circle of Care at Ben White Health Clinic, Austin, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empathy in Action for life with diabetes.

Behavioral

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

Behavioral
  • 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

Primary outcomes

  1. Hemoglobin A1C (HbA1c)

    Time frame: 6 months

    Finger stick point-of-care portable device

Secondary outcomes

  1. Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)

    Time frame: 6 months

    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).

  2. Diastolic and systolic blood pressure (mmHg)

    Time frame: 6 months

    Direct measurement with automatic blood pressure cuff

  3. Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)

    Time frame: 6 months

    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).

  4. General health/quality of life as measured by scores on the MOS Short-form 12-item (SF-12)

    Time frame: 6 months

    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.

  5. Medication adherence as measured by scores on the Medication Adherence Report Scale 5-item (MARS-5)

    Time frame: 6 months

    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. Perceived Diabetes Self-Management Scale (PDSMS)

    Time frame: 6 months

    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.

  7. Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item

    Time frame: 6 months

    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.

  8. Loneliness measured by scores on the 3-item UCLA Loneliness Scale

    Time frame: 6 months

    Self-administered. Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.

  9. Diabetes distress measured by the 2-item Diabetes Distress Screening Scale

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Lone Star Circle of Care

Registry information

Acronym: EIA-Diabetes

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 30, 2021
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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