Empathy in Action: Sunshine Calls for Life With Diabetes

NCT05173675 | Completed

• 1 other identifier: STUDY00001571
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

Telephone; Empathy; Layperson; Self-Management; Incentives

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C (HbA1c)

  Finger stick point-of-care portable device

  6 months

Secondary Outcomes (9)

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

  6 months

• Diastolic and systolic blood pressure (mmHg)

  6 months

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

  6 months

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

  6 months

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

  6 months

Study Arms (2)

Program arm

EXPERIMENTAL

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.

Control arm

OTHER

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

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.

Program arm

Control Phase 2 Materials Only BEHAVIORAL

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

Control arm

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Lone Star Circle of Care: collaborator

Study Sites (9)

Lone Star Circle of Care at Ben White Health Clinic

Austin, Texas, 78704, United States

Location

Lone Star Circle of Care at El Buen Samaritano

Austin, Texas, 78745, United States

Location

Lone Star Circle of Care at Collinfield

Austin, Texas, 78758, United States

Location

Lone Star Circle of Care at Northwest Austin

Austin, Texas, 78759, United States

Location

Lone Star Circle of Care at Bastrop

Bastrop, Texas, 78602, United States

Location

Lone Star Circle of Care at Cedar Park

Cedar Park, Texas, 78613, United States

Location

Lone Star Circle of Care at Lake Aire Medical Center

Georgetown, Texas, 78628, United States

Location

Lone Star Circle of Care at Pflugerville

Pflugerville, Texas, 78660, United States

Location

Lone Star Circle of Care at Texas A&M Health Science Center

Round Rock, Texas, 78665, United States

Location

Related Publications (1)

• Kahlon MK, Aksan NS, Aubrey R, Clark N, Cowley-Morillo M, DuBois C, Garcia C, Guerra J, Pereira D, Sither M, Tomlinson S, Valenzuela S, Valdez MR. Glycemic Control With Layperson-Delivered Telephone Calls vs Usual Care for Patients With Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2448809. doi: 10.1001/jamanetworkopen.2024.48809.

  PMID: 39656459 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Psychological Well-Being; Health Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Personal Satisfaction; Behavior

Study Officials

• Maninder Kahlon, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff responsible for biomedical data collection at the sites are blinded to the status of the participant as part of control or intervention group. Self-reported outcomes are reported by participants on a tablet.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial, stratified by PHQ-9 baseline scores (cut-off ≥5), on a 1:1 ratio

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 30, 2021
• Study Start: February 12, 2022
• Primary Completion: November 20, 2023
• Study Completion: April 29, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)