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

August 5, 2020 updated by: Ying Gao, Dongzhimen Hospital, Beijing

Development and Validation of the Telephone Interview Form for Stroke Outcome

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Criterion validity of the Telephone Interview Form
Time Frame: Baseline, 3 days after baseline, 6 days after baseline
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
Time Frame: 3 days after baseline, 6 days after baseline
The agreement of the Telephone Interview Form when administrated by two different rates
3 days after baseline, 6 days after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Telephone Interview Form
Time Frame: 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
3 days after baseline, 6 days after baseline
Specificity of Telephone Interview Form
Time Frame: 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
3 days after baseline, 6 days after baseline
Internal consistency reliability of Barthel Index questionaire in Telephone Interview Form
Time Frame: Baseline, 3 days after baseline, 6 days after baseline
Internal consistency reliability of Barthel Index questionaire will be evaluated.
Baseline, 3 days after baseline, 6 days after baseline
Convergent validity of Telephone Interview Form
Time Frame: 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)
Baseline, 3 days after baseline, 6 days after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongzhimen Hospital, Beijing

Investigators

  • Principal Investigator: Ying Gao, Dongzhimen Hospital affiliated to Beijing University of Chinese

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-JYBZZ-XS147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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