Dynamic Web-Based Interventions to Improve Update of Prev... | NCT05997537

Studies
Dynamic Web-Based Interventions to Improve Update of Preventive Health Recommendations in IBD

NCT05997537

Sponsor

Cedars-Sinai Medical Center

Status

Completed

Last Update Posted

Aug 18, 2023Actual

Enrollment

1,056Actual

Phase

Not provided

Conditions

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2019Actual

Primary Completion Date

Mar 7, 2022Actual

Completion Date

Mar 7, 2022Actual

First Submitted Date

Aug 4, 2023

First Submission Date that Met QC Criteria

Aug 15, 2023

First Posted Date

Aug 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2023

Last Update Posted Date

Aug 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gil Melmed, Clinical Director of Inflammatory Bowel Disease, Cedars-Sinai Medical CenterPrincipal Investigator

Lead Sponsor

Cedars-Sinai Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,056Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uptake of influenza vaccination	Uptake of influenza vaccination	Through study completion, no later than March 31, 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gil Melmed, MD	Cedars-Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai		Los Angeles	California	90048	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37610821	Derived	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.