IBDNCT05997537
Dynamic Web-Based Interventions to Improve Update of Preventive Health Recommendations in IBD
An observational study of IBD, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD
- How many people
- 1,056 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 7 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in IBD Partners, age 18 and older who have agreed to be contacted for future studies.
Who may be able to join
- enrollees in the internet-based cohort IBD Partners, age 18 and older
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- IBD
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of influenza vaccination
Uptake of influenza vaccination
Measured: Through study completion, no later than March 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start25 Feb 2019
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Melmed, Cedars-Sinai Medical Center
- Investigators
- Gil Melmed, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997537
- Sponsor's protocol ID
- Pro00056067
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37610821
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Web-Based Interventions to Improve Update of Preventive Health Recommendations in IBD
- ClinicalTrials.gov ID
- NCT05997537
- Acronym / sponsor ID
- Pro00056067
- Conditions
- IBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in IBD Partners, age 18 and older who have agreed to be contacted for future studies.
Key inclusion criteria (1 listed)
- enrollees in the internet-based cohort IBD Partners, age 18 and older
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uptake of influenza vaccination
Time frame: Through study completion, no later than March 31, 2020
Uptake of influenza vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Derived from this study: PubMed 37610821Long 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil Melmed, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of influenza vaccination (time frame: Through study completion, no later than March 31, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.