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NCT05777616 Clinical Trial

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

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05777616
Other study ID # 2021-0592
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2021
Est. completion date December 28, 2021

Study information
Verified date March 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date December 28, 2021
Est. primary completion date December 28, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence 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
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