Development and Validation of the Patient-completed Caprini Risk Score

Venous Thromboembolism Clinical Trial

Official title:

Patient-Completed Caprini Risk Score for Venous Thromboembolism Risk Assessment Developed and Validated From 1017 Medical and Surgical Patients: a Diagnostic Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663477
• Other study ID #: VTE-CRS-study
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: China-Japan Friendship Hospital
• Contact: Zhenguo Zhai, MD.PhD
• Phone: (+86)010-84201000
• Email: zhaizhenguo2011[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators aimed to test the reliability and validity of the Chinese version of patient-completed CRS in hospitalized patients and to evaluate whether this form can be widely used in clinical practice instead of only health care workers' evaluation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1017
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients older than 18 years

• patients with first admission to the medical and surgical units within 24 hours

• willingness to participate in the study

Exclusion Criteria:

• patients with a diagnosis of PTE or DVT on admission

• patients with cognitive impairment

• inability to read or write

• patients with mental diseases

• patients with visual impairment

• refusal to cooperate

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Diagnostic Test:
• patient-completed Caprini Risk Score
The participants will be asked to complete patient-completed Caprini Risk Score

Locations

Country	Name	City	State
China	China-Japan Frendship hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Question-to-question agreement between patient-completed and nurse-completed CRS	The investigators will use kappa value to compare the question-to-question agreement level between nurse and patient-completed Caprini Risk Score	one year
Secondary	Correlation and difference between the scores calculated by patient-completed and nurse-completed CRS	The Spearman correlation coefficient was used to measure the correlation and difference between patient-completed and nurse-completed CRS.	one year