StrokeARISENCT04062188
VAlidity and Reliability of the Telephone Interview Form for Stroke Outcome Evaluation
An observational study of Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Telephone Interview Form
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2019to 1 Feb 2021
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population are clinically stable stroke patients with the course between 1 to 12 months.
Who may be able to join
- 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.
Who cannot join
- Patients with psychological or mental disorders.
- Patients suffer from other so severe diseases that they can't complete the follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Luda Feng, luda_feng@hotmail.com
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Telephone Interview Form
- Keywords
- Stroke outcomes, Telephone interview, Modified Rankin Scale questionnaire, Barthel Index questionnaire, Validity study, Reliability study
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Interview FormOther
Also called Telephone Interview Questionnaire
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Criterion validity of the Telephone Interview Form
The agreement between the Telephone Interview Form and face-to-face assessment.
Measured: 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
Measured: 3 days after baseline, 6 days after baseline
Secondary outcomes (4)
Sensitivity of Telephone Interview Form
Sensitivity of Telephone Interview Form when administered by telephone compared with face-to-face at various cut-off values
Measured: 3 days after baseline, 6 days after baseline
Specificity of Telephone Interview Form
Specificity of Telephone Interview Form when administered by telephone compared with face-to-face at various cut-off values
Measured: 3 days after baseline, 6 days after baseline
Internal consistency reliability of Barthel Index questionaire in Telephone Interview Form
Internal consistency reliability of Barthel Index questionaire will be evaluated.
Measured: Baseline, 3 days after baseline, 6 days after baseline
Convergent validity of Telephone Interview Form
Relationship between Telephone Interview Form and other scales (i.e. (National Institute of Health stroke scale)
Measured: Baseline, 3 days after baseline, 6 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start22 Dec 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, Principal investigator, Dongzhimen Hospital affiliated to Beijing University of Chinese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062188
- Sponsor's protocol ID
- 2018-JYBZZ-XS147
- Acronym
- ARISE
- Status last verified
- Aug 2020
- First submitted
- 15 Aug 2019
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Telephone Interview Form for Stroke Outcome
- ClinicalTrials.gov ID
- NCT04062188
- Acronym / sponsor ID
- ARISE / 2018-JYBZZ-XS147
- Conditions
- Stroke
- Keywords
- Stroke outcomes, Telephone interview, Modified Rankin Scale questionnaire, Barthel Index questionnaire, Validity study, Reliability study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 22 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 7 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are clinically stable stroke patients with the course between 1 to 12 months.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with psychological or mental disorders.
- Patients suffer from other so severe diseases that they can't complete the follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Interview FormAlso: Telephone Interview QuestionnaireTelephone 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. | Other | – |
Primary outcome
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.
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
4 secondary outcomes
Sensitivity of Telephone Interview Form
Time frame: 3 days after baseline, 6 days after baseline
Specificity of Telephone Interview Form
Time frame: 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
Convergent validity of Telephone Interview Form
Time frame: Baseline, 3 days after baseline, 6 days after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Gao principal investigator
Dongzhimen Hospital affiliated to Beijing University of Chinese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Gao (0086-010-84013209, gaoying973@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Criterion validity of the Telephone Interview Form (time frame: Baseline, 3 days after baseline, 6 days after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.