Empathy in Action: Sunshine Calls for Life With Diabetes

NCT ID: NCT05173675

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-12
• Study Completion Date: 2024-04-29

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Empathy in Action for life with diabetes.

Intervention Type: 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 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.

Group Type: OTHER

Control Phase 2 Materials Only

Intervention Type: 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

Interventions

Empathy in Action for life with diabetes.

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.

Intervention Type: BEHAVIORAL

Control Phase 2 Materials Only

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lone Star Circle of Care

UNKNOWN

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Maninder Kahlon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maninder Kahlon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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

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, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39656459 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00001571

Identifier Type: -

Identifier Source: org_study_id