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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention, up to 6 months

Awards & highlights

T1DALPilot Trial 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.Check my eligibility

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.See study design

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.

T1DALPilot Trial 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.

T1DALPilot Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Interventional procedure

Secondary outcome measures

Adherence/Diabetes Self-management

Diabetes distress

Diabetes health-related quality of life

+2 more

T1DALPilot 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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,132 Total Patients Enrolled

The Leona M. and Harry B. Helmsley Charitable TrustOTHER

57 Previous Clinical Trials

93,773 Total Patients Enrolled

Marisa Hilliard, PhDPrincipal InvestigatorBaylor College of Medicine

1 Previous Clinical Trials

330 Total Patients Enrolled

Media Library

Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05234944 — N/A

Type 1 Diabetes Research Study Groups: Intervention

Type 1 Diabetes Clinical Trial 2023: Intervention Highlights & Side Effects. Trial Name: NCT05234944 — N/A

Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05234944 — N/A

Frequently Asked Questions

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

Is recruitment still available for this trial?

"According to clinicaltrials.gov, this research trial is not presently recruiting participants - which it had done so since December 9th 2022 until February 7th 2023. However, there exist 1241 additional studies actively inviting individuals to take part in their investigation."

Answered by AI

What primary goals is the trial trying to achieve?

"This trial aims to gauge the Acceptability of an intervention over 6 months. Secondary measurements include Diabetes distress, Glycemic Outcome - Time in Range, and Glycemic Outcome - HbA1c. The former is measured using the Problem Areas in Diabetes (PAID) scale for younger patients or a Diabetes Distress Scale for adults; higher scores correlate with more distress. For measuring glycemic outcomes, continuous glucose monitor data will be downloaded from those who use one, while other participants must self-report their most recent HbA1c values and upload documentation as necessary. Finally, home fingerstick kits may also be used to"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study of Brief Intervention to Support Diabetes Health-Related Quality of Life

Marisa Hilliard 2022. "Pilot Study of Brief Intervention to Support Diabetes Health-Related Quality of Life". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05234944.

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