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Behavioral Intervention

Empathy-Focused Support Calls for Diabetes (EIA-Diabetes Trial)

N/A
Waitlist Available
Led By Maninder Kahlon, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HbA1c ≥ 7.5% at baseline measurement and 8.0% at least one time 12 months prior to study enrollment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

EIA-Diabetes Trial Summary

This trial found that a telephonic layperson-delivered empathy and relationship-focused program improved diabetes management and mental health for patients at a Federally Qualified Health Center, compared to usual care.

Who is the study for?
This trial is for patients with Type 2 Diabetes who have visited Lone Star Circle of Care in the past year and have high HbA1c levels. They must be willing to complete a mental health questionnaire (PHQ-9). People with severe cognitive issues, serious mental illness, end-stage renal disease, current pregnancy, low HbA1c levels, cancer treatment or on certain immune therapies can't join.Check my eligibility
What is being tested?
The study tests an empathy-focused phone program's ability to help manage diabetes and improve mental health against usual care at a Federally Qualified Health Center. Participants are randomly placed into two groups: one receives the empathy calls while the other gets standard materials only.See study design
What are the potential side effects?
Since this intervention involves telephonic support rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or distress during sensitive discussions about their condition.

EIA-Diabetes Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My HbA1c was at least 7.5% recently and 8.0% or higher in the past year.

EIA-Diabetes Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin A1C (HbA1c)
Secondary outcome measures
Anxiety as measured by scores on the Generalized Anxiety Disorder 7-item (GAD-7)
Depression as measured by scores on the Patient Health Questionnaire 9-item (PHQ-9)
Diabetes Self-Efficacy measured by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
+6 more

EIA-Diabetes Trial Design

2Treatment groups
Experimental Treatment
Group I: Program armExperimental Treatment1 Intervention
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 II: Control armExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
350 Previous Clinical Trials
80,724 Total Patients Enrolled
Lone Star Circle of CareUNKNOWN
1 Previous Clinical Trials
82 Total Patients Enrolled
Maninder Kahlon, PhDPrincipal InvestigatorUniversity of Texas at Austin
4 Previous Clinical Trials
757 Total Patients Enrolled

Media Library

Empathy in Action for life with diabetes (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05173675 — N/A
Type 2 Diabetes Research Study Groups: Program arm, Control arm
Type 2 Diabetes Clinical Trial 2023: Empathy in Action for life with diabetes Highlights & Side Effects. Trial Name: NCT05173675 — N/A
Empathy in Action for life with diabetes (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05173675 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there several medical centers conducting this clinical research in the city?

"In the Lone Star State, there are 9 clinical trial sites recruiting patients for this medical study. These include Ben White Health Clinic in Austin and Lake Aire Medical Center in Georgetown; Round Rock's El Buen Samaritano is also on the list of accredited locations alongside 6 other healthcare facilities."

Answered by AI

Are younger patients being considered for participation in the trial?

"This clinical trial has defined the upper and lower age limits of eligibility; applicants must be between 21 years old and 70 years young."

Answered by AI

Are enrollees being accepted for this research project currently?

"According to information found on clinicaltrials.gov, this medical experiment is not presently looking for trial participants, as the last update was on May 25th 2022 since its initial posting of February 12th 2022. All hope is not lost though; an immense total of 1613 other research trials are currently seeking subjects."

Answered by AI

Who is able to partake in this experiment?

"This clinical trial has space for 300 individuals aged between 21 and 70 with type 2 diabetes mellitus. Notably, all applicants must have an HbA1c score of ≥ 7.5% at baseline evaluation as well as 8.0% in the 12 months before study commencement, a visit to Lone Star Circle of Care (either telehealth or physical) within that same period, plus consent to extensively fill out PHQ-9 form on site when enrolling (due to stratified randomization design)."

Answered by AI

Who else is applying?

What site did they apply to?
Lone Star Circle of Care at Northwest Austin
Lone Star Circle of Care at Texas A&M Health Science Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Empathy in Action: Sunshine Calls for Life With Diabetes
Maninder Kahlon 2022. "Empathy in Action: Sunshine Calls for Life With Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05173675.
~82 spots leftby Apr 2025
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