NCT05997537

Brief Summary

To understand patient knowledge, attitudes, and beliefs around the uptake of vaccinations and malignancy screening through patient focus groups/qualitative interviews. To develop and pilot an interactive website that will provide customized recommendations for individual patients with IBD and direct them as relevant to five 60-90 second customized, animated videos (influenza, pneumococcal, and zoster vaccinations, bone health, and skin cancer screening). This content will be pilot-tested with patients to fine-tune the educational modules.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,056

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

August 4, 2023

Last Update Submit

August 15, 2023

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

  • Uptake of influenza vaccination

    Uptake of influenza vaccination

    Through study completion, no later than March 31, 2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients enrolled in IBD Partners, age 18 and older who have agreed to be contacted for future studies.

You may qualify if:

  • enrollees in the internet-based cohort IBD Partners, age 18 and older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai

Los Angeles, California, 90048, United States

Location

Related Publications (1)

  • Long MD, van Deen WK, Weisbein L, Khalil C, Appel KL, Zhang X, Chen W, Zubrod L, Maris R, Ghafari A, Dupuy T, Ha CY, Spiegel BMR, Almario CV, Melmed GY. Web-Based Video Education to Improve Uptake of Influenza Vaccination and Other Preventive Health Recommendations in Adults With Inflammatory Bowel Disease: Randomized Controlled Trial of Project PREVENT. J Med Internet Res. 2023 Aug 23;25:e42921. doi: 10.2196/42921.

    PMID: 37610821DERIVED

Study Officials

  • Gil Melmed, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director of Inflammatory Bowel Disease

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 18, 2023

Study Start

February 25, 2019

Primary Completion

March 7, 2022

Study Completion

March 7, 2022

Last Updated

August 18, 2023

Record last verified: 2023-08

Locations

US(1)