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NCT05635292 · ClinicalTrials.gov registry record · NA
Addressing Disability Effectively With Psychosocial Telemedicine
A NA study of Crohn Disease, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 715
- Enrollment target
- 1
- Study location
NCT05635292: Completed NA study of Crohn Disease, sponsored by University of Pennsylvania.
NCT05635292 is a NA study of Crohn Disease that has completed, run by University of Pennsylvania. The registered enrollment target is 715 participants, above the 195-participant average among 71 other Crohn Disease trials with a reported enrollment target (267% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05635292, a NA study of Crohn Disease, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 715 participants
- Enrollment target
- 1
- Study location
Study Summary
This multi-site study will be implemented at 5 gastroenterology practices to recruit 420 adults with IBD to complete a baseline survey and enroll those with higher scores on a validated IBD-disability scale into a randomized controlled trial of telehealth-delivered cognitive behavioral therapy with a licensed psychologist versus usual care. The investigators aim to lay the foundations that will shift the paradigm of IBD clinical practice towards a new horizon of holistic and equitable high-value care.
Primary Outcome
Change in the IBD Disability is estimated by the 14-item validated IBD Disability Index (IBD-DI) in the intervention group (telemedicine-delivered psychosocial care) vs control group (usual care) in patients with moderate-to-severe baseline IBD-related disability pre and post intervention (week 0 and week 8). Total score ranges from 0-100, interpreted as 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability), and 50-100 (severe disability).
Conditions Studied
Interventions
- BEHAVIORAL Tele-CBT
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 715 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2024-01-31 |
| Phase | NA |
What the finished NCT05635292 record still lists
NCT05635292 is an interventional study that assigns participants to a tested intervention. The registered 715 participants enrollment target is mid-sized for trials with a published cap, above the 195-participant average among 71 other Crohn Disease trials with a reported enrollment target (267% higher).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 1 intervention - of which Tele-CBT is the first listed.
NCT05635292 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05635292 about?
NCT05635292 is a clinical study titled "Addressing Disability Effectively With Psychosocial Telemedicine". This multi-site study will be implemented at 5 gastroenterology practices to recruit 420 adults with IBD to complete a baseline survey and enroll those with higher scores on a validated IBD-disability scale into a randomized controlled trial of telehealth-delivered cognitive behavioral therapy with ...
What is the current status of trial NCT05635292?
This trial is currently completed. It is a NA study. The enrollment target is 715 participants. The study started on 2023-02-15. Estimated completion is 2024-01-31.
What conditions does trial NCT05635292 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT05635292?
The interventions under investigation include: Tele-CBT (BEHAVIORAL).
Who is sponsoring clinical trial NCT05635292?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05635292 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05635292's enrollment target sits among peer trials
715 7th of 71 higher than 65 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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