Addressing Disability Effectively With Psychosocial Telemedicine

Crohn Disease Clinical Trial

— ADEPT  

Official title:

Addressing Disability Effectively With Psychosocial Telemedicine (ADEPT Study): An Open-label, Multicenter Pragmatic Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05635292
• Other study ID #: 851901
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: January 3, 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults =18 years old with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC)

2. 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

3. Able to consent and complete surveys in English.

Exclusion Criteria:

1. no/low disability (IBD-DI <35) on the baseline survey

2. inability or unwillingness to participate in telemedicine with a therapist

3. Have an existing relationship with a mental health specialist within the past 3 months

4. Lack of access to a computer, working internet connection, and a private environment to complete teletherapy sessions if they are randomized to this intervention

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Behavioral:
• Tele-CBT
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)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the IBD Disability Index	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	Cost-benefits of telemedicine-delivered psychosocial care	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

External Links

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