COVID-19NCT05195736
Predicting COVID-19 Patients' Clinical Outcomes Using ICU Mobility Scale and MRC Sum Score
An observational study of COVID-19, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The investigators hypothesize that early mobility condition and muscle power may be the predictive factors for Coronavirus disease 2019(COVID-19) patients' activity prognosis and hospitalization days. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2021to 31 Dec 2021
- 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: COVID-19 patients admitted at Taichung VGH from 2020/1/1 to 2021/6/15
Who may be able to join
- COVID-19 patients diagnosed by positive polymerase chain reaction(PCR)
Who cannot join
- Impaired baseline activities, such as stroke, fracture, neurodegenerative disease
- Baseline Barthel index score less than 100
- Lost follow-up
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Veterans General Hospital
Taichung, Republic of China(R.O.C), 40705
About this study
Official title: Predicting COVID-19 Patients' Barthel Index and Hospitalization Using ICU Mobility Scale and Medical Research Council Sum Score
The investigators hypothesize that early mobility condition and muscle power may be the predictive factors for Coronavirus disease 2019(COVID-19) patients' activity prognosis and hospitalization days. To prove our hypothesis, the investigators proposed a retrospective cohort study to see if ICU mobility scale(ICUMS) and Medical Research Council Sum Score(MRCSS) can predicted the patients' Barthel index after discharge and hospitalization days.
Read the detailed description
The investigators hypothesize that early mobility condition and muscle power may be the predictive factors for COVID-19 patients' activity prognosis and hospitalization days. To prove our hypothesis, the investigators checked the patient's baseline ICUMS and MRCSS upon admission. Also, blood test results were also obtained. Subsequently, the investigators measured their outcomes by Barthel index and hospitalization length, and divided them into two groups. The ICUMS, MRCSS and the blood test results differences between two groups were checked. For those factors that showed significant difference between two groups, the investigators recruited them into regression model. Last, receiver operating curve of those factors were plotted to find the appropriate cutoff points for identifying two groups of outcomes.
- Conditions
- COVID-19
- Keywords
- COVID-19, Activities of Daily Living, Muscle Strength
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index
Score from 0 to100. Higher score indicates better daily activities of living.
Measured: Barthel index score 3 months after discharge
Hospitalization days
Hospitalization days
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start16 Sep 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195736
- Sponsor's protocol ID
- CE21317A#1
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting COVID-19 Patients' Barthel Index and Hospitalization Using ICU Mobility Scale and Medical Research Council Sum Score
- ClinicalTrials.gov ID
- NCT05195736
- Acronym / sponsor ID
- CE21317A#1
- Conditions
- COVID-19
- Keywords
- COVID-19, Activities of Daily Living, Muscle Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Jan 2022 (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 hypothesize that early mobility condition and muscle power may be the predictive factors for Coronavirus disease 2019(COVID-19) patients' activity prognosis and hospitalization days. To prove our hypothesis, the investigators proposed a retrospective cohort study to see if ICU mobility scale(ICUMS) and Medical Research Council Sum Score(MRCSS) can predicted the patients' Barthel index after discharge and hospitalization days.
Detailed description
The investigators hypothesize that early mobility condition and muscle power may be the predictive factors for COVID-19 patients' activity prognosis and hospitalization days. To prove our hypothesis, the investigators checked the patient's baseline ICUMS and MRCSS upon admission. Also, blood test results were also obtained. Subsequently, the investigators measured their outcomes by Barthel index and hospitalization length, and divided them into two groups. The ICUMS, MRCSS and the blood test results differences between two groups were checked. For those factors that showed significant difference between two groups, the investigators recruited them into regression model. Last, receiver operating curve of those factors were plotted to find the appropriate cutoff points for identifying two groups of outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- COVID-19 patients admitted at Taichung VGH from 2020/1/1 to 2021/6/15
Key inclusion criteria (1 listed)
- COVID-19 patients diagnosed by positive polymerase chain reaction(PCR)
Key exclusion criteria (3 listed)
- Impaired baseline activities, such as stroke, fracture, neurodegenerative disease
- Baseline Barthel index score less than 100
- Lost 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.
Primary outcome
Barthel index
Time frame: Barthel index score 3 months after discharge
Score from 0 to100. Higher score indicates better daily activities of living.
Hospitalization days
Time frame: days
Hospitalization days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 3 Feb 2022. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel index (time frame: Barthel index score 3 months after discharge). 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 3 Feb 2022.