VAlidity and Reliability of the Telephone Interview Form for Stroke Outcome Evaluation

Stroke Clinical Trial

— ARISE  

Official title:

Development and Validation of the Telephone Interview Form for Stroke Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04062188
• Other study ID #: 2018-JYBZZ-XS147
• Status: Recruiting
• Start date: December 22, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: August 2020
• Source: Dongzhimen Hospital, Beijing
• Contact: Ying Gao
• Phone: 0086-010-84013209
• Email: gaoying973[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators combined the mRS questionnaire and BI questionnaire and then developed a telephone interview form as a simple questionnaire with internal rules. The main purpose of this study is to evaluate the validity and reliability of the telephone interview form when compared with face-to-face assessment in clinically stable patients with stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of ischemic or hemorrhagic stroke.

• The course of 1 to 12 months.

• Patient or procuratorial caregiver has a good understanding so as to answer rater's telephone interview.

• Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

• Patients with psychological or mental disorders.

• Patients suffer from other so severe diseases that they can't complete the follow-up.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Telephone Interview Form
Telephone Interview Form is an original simple questionnaire developed based on the combination of Barthel Index questionnaire and simplified modified Rankin Scale questionnaire with internal rules.

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Criterion validity of the Telephone Interview Form	The agreement between the Telephone Interview Form and face-to-face assessment.	Baseline, 3 days after baseline, 6 days after baseline
Primary	Inter-rater reliability of the Telephone Interview Form	The agreement of the Telephone Interview Form when administrated by two different rates	3 days after baseline, 6 days after baseline
Secondary	Sensitivity of Telephone Interview Form	Sensitivity of Telephone Interview Form when administered by telephone compared with face-to-face at various cut-off values	3 days after baseline, 6 days after baseline
Secondary	Specificity of Telephone Interview Form	Specificity of Telephone Interview Form when administered by telephone compared with face-to-face at various cut-off values	3 days after baseline, 6 days after baseline
Secondary	Internal consistency reliability of Barthel Index questionaire in Telephone Interview Form	Internal consistency reliability of Barthel Index questionaire will be evaluated.	Baseline, 3 days after baseline, 6 days after baseline
Secondary	Convergent validity of Telephone Interview Form	Relationship between Telephone Interview Form and other scales (i.e. (National Institute of Health stroke scale)	Baseline, 3 days after baseline, 6 days after baseline