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

• Conditions: Stroke

• Registration Number: NCT04062188
• Lead Sponsor: Dongzhimen Hospital, Beijing

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-20
• Study Start: 2019-12-22
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-06
• Primary Completion: 2020-12-31
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Criterion validity of the Telephone Interview Form	Baseline, 3 days after baseline, 6 days after baseline	The agreement between the Telephone Interview Form and face-to-face assessment.
Inter-rater reliability of the Telephone Interview Form	3 days after baseline, 6 days after baseline	The agreement of the Telephone Interview Form when administrated by two different rates

Secondary Outcome Measures

Name	Time	Method
Sensitivity of Telephone Interview Form	3 days after baseline, 6 days after baseline	Sensitivity of Telephone Interview Form when administered by telephone compared with face-to-face at various cut-off values
Specificity of Telephone Interview Form	3 days after baseline, 6 days after baseline	Specificity of Telephone Interview Form when administered by telephone compared with face-to-face at various cut-off values
Internal consistency reliability of Barthel Index questionaire in Telephone Interview Form	Baseline, 3 days after baseline, 6 days after baseline	Internal consistency reliability of Barthel Index questionaire will be evaluated.
Convergent validity of Telephone Interview Form	Baseline, 3 days after baseline, 6 days after baseline	Relationship between Telephone Interview Form and other scales (i.e. (National Institute of Health stroke scale)

Trial Locations

Locations (1)

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China