The Impact of Medication Belief on Adherence to Inflixima... | NCT05777616

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

NCT05777616

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Completed

Last Update Posted

Mar 21, 2023Actual

Enrollment

166Actual

Phase

Not provided

Conditions

Inflammatory Bowel Diseases

Interventions

Not provided

Countries

China

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

Mar 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

Nov 15, 2021Actual

Primary Completion Date

Dec 28, 2021Actual

Completion Date

Dec 28, 2021Actual

First Submitted Date

Mar 8, 2023

First Submission Date that Met QC Criteria

Mar 8, 2023

First Posted Date

Mar 21, 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

Mar 8, 2023

Last Update Posted Date

Mar 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

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.

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

166Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yan Chen	2nd Affiliated Hospital, School of Medicine, Zhejiang University,China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China		Zhejiang			China

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D003424	Crohn Disease

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided