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Behavioral Intervention for Type 1 Diabetes (T1DALPilot Trial)

N/A

Waitlist Available

Led By Marisa Hilliard, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 1 diabetes diagnosis for at least 12 months

Age 18 years or older (for Parents/Partners)

Must not have

Any major comorbid medical (PWD only), cognitive, or psychiatric condition that would limit ability to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention, up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trialwill explore how a remote behavioral intervention by diabetes educators can support the health-related quality of life of people with type 1 diabetes and their families.

Who is the study for?

This trial is for people with Type 1 diabetes who've had it for at least a year, and their family members. Participants must be fluent in English and over 18 years old if they are parents or partners. It's not open to those with major health issues that could interfere with the study or plans to move away from the clinical site during the trial.

What is being tested?

The study tests a brief behavioral intervention aimed at improving life quality for individuals with Type 1 diabetes and their families. Delivered remotely by educators, it will be assessed across three settings: adult specialty care, pediatric subspecialty care, and primary care without randomization.

What are the potential side effects?

Since this is a behavioral intervention rather than a medication, traditional side effects like you might see with drugs aren't expected. However, participants may experience emotional or psychological responses to the educational content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Type 1 diabetes for over a year.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major health, mental, or cognitive issues that would prevent me from participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention, up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Interventional procedure

Secondary study objectives

Adherence/Diabetes Self-management

Diabetes distress

Diabetes health-related quality of life

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

A CDCES trained by the research team will deliver the intervention via HIPAA compliant telehealth/videoconferencing platform. There will be 2 sessions within approximately 6 months. Prior to each session, participants will complete an assessment of T1D-specific health-related quality of life, which will generate a summary report for each person that lists aspects of quality of life that are going well and aspects that are potential areas for improvement. The CDCES will review the reports with the participants, focusing on building on areas of strength and teaching brief behavioral strategies or resources to address aspects of quality of life that could be improved. Strategies may include stress management, problem-solving techniques, goal-setting, strategies to seek social support, or other brief behavioral skills. The CDCES will also offer information about relevant resources and will provide referrals for mental health support as needed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Type 1 Diabetes and Life

2022

N/A

~120

0 / 3Eligibility criteria met