The Impact of Medication Belief on Adherence to Infliximab in Patients With Crohn's Disease

March 8, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
The IFX adherence to CD in China was not high. Medicine concerns may be predictive factor of adherence. By enhancing knowledge and relieving medicine concerns, we may increase patients' adherence to IFX.

Study Overview

Status

Completed

Conditions

Detailed Description

Crohn's disease (CD) is an incurable chronic disease that requires long-term treatment. As an anti-tumor necrosis factor (TNF) agent, Infliximab (IFX) is widely used in the treatment of Crohn's disease, while the adherence is not high. The purpose of this study was to investigate the adherence to IFX among CD patients in China and evaluate the association between medication belief and IFX adherence.

Study Type

Observational

Enrollment (Actual)

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Zhejiang, China
        • 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study was conducted at the Second Affiliated Hospital, Zhejiang University School of Medicine (SAHZU) from November 15 to December 28, 2021. All CD patients treated with infliximab were retrospectively identified in the electronic medical records (EMRs) from the SAHZU Crohn's and Colitis Center.

Description

Inclusion Criteria:

  • patients with a confirmed diagnosis of CD; were treated with infliximab for at least 12 weeks; were informed consent.

Exclusion Criteria:

  • The exclusion criteria were received treatment from mental health professionals due to any mental or cognitive impairment; suffered from other serious diseases, such as heart, brain, lung, liver and kidney dysfunction; severe infection, anemia, cachexia or other serious complications were found.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: November 15 to December 28, 2021
Adherence was judged by comparing the theoretical infusion times with the actual infusion times in recent 1 year, which was referred to the definition of modified medication possession radio (mMPR)
November 15 to December 28, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Yan Chen, 2nd Affiliated Hospital, School of Medicine, Zhejiang University,China

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)

November 15, 2021

Primary Completion (Actual)

December 28, 2021

Study Completion (Actual)

December 28, 2021

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0592

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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