Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03324438 · ClinicalTrials.gov registry record · NA
Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
NCT03324438 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 108 participants.
The verdict
NCT03324438, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
Study Summary
This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Lack of regular contact with T1D care providers, continued T1D nonadherence, and suboptimal behavioral and mental health functioning compromises the physical health of youth with T1D and the ability of T1D teams to provide effective treatment. If the aims of this study are achieved, this study will change T1D care practices by providing high-risk youth with T1D, and their parents, medical and behavioral health support via home telehealth intervention. This has the potential to significantly change access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital admissions, and improve glycemic control. In addition, this study's use of Multiphase Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective intervention components, should be generalizable to all individuals with T1D, leading to cost-effective, home telehealth intervention programs. Innovative aspects include: 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Interventions
- BEHAVIORAL Home Telehealth T1D C2oYoT1-HR
- BEHAVIORAL Personalized Behavioral Health
- BEHAVIORAL Personalized Adherence Feedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2021-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03324438
The ClinicalTrials.gov registry entry for NCT03324438 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Home Telehealth T1D C2oYoT1-HR is the first listed.
NCT03324438 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03324438 about?
NCT03324438 is a clinical study titled "Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes". This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Lack of ...
What is the current status of trial NCT03324438?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2017-11-01. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT03324438?
The interventions under investigation include: Home Telehealth T1D C2oYoT1-HR (BEHAVIORAL), Personalized Behavioral Health (BEHAVIORAL), Personalized Adherence Feedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT03324438?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.