- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05635292
Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT)
February 20, 2024 updated by: University of Pennsylvania
Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT Study): An Open-label, Multicenter Pragmatic Randomized Control Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
667
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brittaney Bonhomme
- Phone Number: 2158982625
- Email: bobrit@pennmedicine.upenn.edu
Study Contact Backup
- Name: Lisa Nessel
- Phone Number: 2155736003
- Email: nessel@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults ≥18 years old with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC)
- Willingness to complete the baseline survey online. Participants in Aim 1 with moderate-to-severe disability based on the IBD Disability Index (IBD-DI) will be invited to the Aim 2 clinical trial
- Able to consent and complete surveys in English.
Exclusion Criteria:
- no/low disability (IBD-DI <35) on the baseline survey
- inability or unwillingness to participate in telemedicine with a therapist
- Have an existing relationship with a mental health specialist within the past 3 months
- Lack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Tele-CBT
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8 weekly 1-hr telemedicine visits with a licensed Ph.D. psychologist from the University of Pennsylvania (permissible to practice across state lines under PSYPACT), plus usual care and referral to an IBD Help Center (email, phone, online chat with IBD information specialist)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the IBD Disability Index
Time Frame: 8 weeks
|
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).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-benefits of telemedicine-delivered psychosocial care
Time Frame: 8 weeks
|
The cost-benefits of tele-CBT are estimated by 5-item validated Centers for Medicare & Medicaid Services (CMS)-certified FAIR Health database questionnaire titled the Treatment Inventory of Costs in Patients (TIC-P).
The minimum value is $0, with no maximum value.
Higher costs indicate worse outcome.
In order to calculate the costs of productivity losses, the healthcare utilization encounter are multiplied by the cost price per unit.
The cost of unpaid productivity loss is calculated by multiplying the productivity losses by a standard hourly rate for household care.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chung Sang Tse, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2023
Primary Completion (Actual)
January 3, 2024
Study Completion (Actual)
January 3, 2024
Study Registration Dates
First Submitted
November 10, 2022
First Submitted That Met QC Criteria
November 22, 2022
First Posted (Actual)
December 2, 2022
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 851901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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