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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT05777616
Collaborator
(none)
166
Enrollment
1
Location
1.4
Actual Duration (Months)
117.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    166 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Impact of Medication Belief on Adherence to Infliximab in Patients With Crohn's Disease
    Actual Study Start Date :
    Nov 15, 2021
    Actual Primary Completion Date :
    Dec 28, 2021
    Actual Study Completion Date :
    Dec 28, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Adherence [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China Zhejiang China

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05777616
    Other Study ID Numbers:
    • 2021-0592
    First Posted:
    Mar 21, 2023
    Last Update Posted:
    Mar 21, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    Crohn's disease; adherence; medication concern; infliximab
    Additional relevant MeSH terms:
    Crohn Disease
    Inflammatory Bowel Diseases

    Study Results

    No Results Posted as of Mar 21, 2023