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

NCT04062188 | Unknown

• 1 other identifier: 2018-JYBZZ-XS147
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke outcomes; Telephone interview; Modified Rankin Scale questionnaire; Barthel Index questionnaire; Validity study; Reliability study

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Sensitivity of Telephone Interview Form

  3 days after baseline, 6 days after baseline

• Specificity of Telephone Interview Form

  3 days after baseline, 6 days after baseline

• Internal consistency reliability of Barthel Index questionaire in Telephone Interview Form

  Baseline, 3 days after baseline, 6 days after baseline

• Convergent validity of Telephone Interview Form

  Baseline, 3 days after baseline, 6 days after baseline

Interventions

Telephone Interview Form OTHER

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.

Also known as: Telephone Interview Questionnaire

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population are clinically stable stroke patients with the course between 1 to 12 months.

You may qualify if:

• 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.

You may not qualify if:

• Patients with psychological or mental disorders.
• Patients suffer from other so severe diseases that they can't complete the follow-up.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ying Gao

  Dongzhimen Hospital affiliated to Beijing University of Chinese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Gao

CONTACT

0086-010-84013209; gaoying973@126.com

Luda Feng

CONTACT

(+86)13051528128; luda_feng@hotmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Institute for Brain Disorders, Beijing University of Chinese Medicine

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 20, 2019
• Study Start: December 22, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 1, 2021
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

CN (1)