Subarachnoid Hemorrhage, SpontaneousDETERMINESAHNCT04357626
Determinants of Rehabilitation Outcomes in Survivors of Primary Subarachnoid Haemorrhage
An observational study of Subarachnoid Hemorrhage, Spontaneous, run by Tan Tock Seng Hospital at 2 sites in Singapore.
Trial summary
A retrospective, observational single centre study of electronic medical records of discharged patients who were admitted to from 1 January 2015 to 31 December 2018. Period of data collection was from 5 August 2019 to 15 September 2019. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Spontaneous
- What is being tested?
- Inpatient Rehabilitation
- How many people
- 114 participants
- Where
- 2 sitesSingapore
- Study dates
- 6 Aug 2019to 15 Sep 2019
- 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 21 to 85 years
- All sexes
- Adult, Older adult
Study population: Adult patients admitted acutely for inpatient rehabilitation from neurosurgical wards
Who may be able to join
- 1. Spontaneous, first-ever SAH diagnosed by admitting neurosurgeons and confirmed on neuroimaging (CT or magnetic resonance imaging) 2. Transferred from acute care facilities or admitted from clinics to TTSH RC 3. Ages between 21 - 85 years 4. Duration of SAH to rehabilitation admission ≤6 months
Who cannot join
- 1. No radiological evidence of SAH 2. Traumatic SAH 3. Previous diagnosis of SAH 4. Main reason for admission into TTSH RC was not for inpatient rehabilitation (e.g. wound care, medical or social admission)
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Tan Tock Seng Hospital
Singapore, 308433
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, 569766
About this study
Official title: Determinants of Rehabilitation Outcomes in Survivors of Primary Subarachnoid
A retrospective, observational single centre study of electronic medical records of discharged patients who were admitted to from 1 January 2015 to 31 December 2018.
Period of data collection was from 5 August 2019 to 15 September 2019.
Read the detailed description
The objectives of this study were to describe a local cohort of acute SAH survivors during inpatient rehabilitation at a single tertiary rehabilitation centre in Singapore and identify early predictors impacting discharge rehabilitation outcomes.
- Conditions
- Subarachnoid Hemorrhage, Spontaneous
- Being tested
- Inpatient Rehabilitation
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient RehabilitationOther
Observational electronic records review study during inpatient rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Completed discharged hospital rehabilitation electronic record | Completed discharged hospital rehabilitation electronic record of patients who underwent inpatient rehabilitation as part of routine clinical care. Receives: Other: Inpatient Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM score)
The FIM, scored between 18 - 126, comprises of 18 items (motor and cognitive sub scores) which assesses a patient's degree of disability and indicates the degree of assistance required for activities of daily living. FIM scoring is widely used for functional scoring in patients with neurologic pathologies such as stroke or traumatic brain injury. Studies on its utility have shown high reliability, validity, and sensitivity for measuring functional ability and high consistency with other functional scales such as the Barthel Index
Measured: Within 72 hours of discharge from rehabilitation
Secondary outcomes (1)
FIM Change
Difference between FIM discharge and admission
Measured: Within 72 hours of admission and discharge from rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start6 Aug 2019
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, SpontaneousStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen S Chua, MBBS FRCPE, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357626
- Sponsor's protocol ID
- DSRB 2019/00594
- Acronym
- DETERMINESAH
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Rehabilitation Outcomes in Survivors of Primary Subarachnoid
- ClinicalTrials.gov ID
- NCT04357626
- Acronym / sponsor ID
- DETERMINESAH / DSRB 2019/00594
- Conditions
- Subarachnoid Hemorrhage, Spontaneous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 22 Apr 2020 (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.
A retrospective, observational single centre study of electronic medical records of discharged patients who were admitted to from 1 January 2015 to 31 December 2018.
Period of data collection was from 5 August 2019 to 15 September 2019.
Detailed description
The objectives of this study were to describe a local cohort of acute SAH survivors during inpatient rehabilitation at a single tertiary rehabilitation centre in Singapore and identify early predictors impacting discharge rehabilitation outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Completed discharged hospital rehabilitation electronic record | – | Other: Inpatient RehabilitationCompleted discharged hospital rehabilitation electronic record of patients who underwent inpatient rehabilitation as part of routine clinical care. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted acutely for inpatient rehabilitation from neurosurgical wards
Key inclusion criteria (1 listed)
- 1. Spontaneous, first-ever SAH diagnosed by admitting neurosurgeons and confirmed on neuroimaging (CT or magnetic resonance imaging) 2. Transferred from acute care facilities or admitted from clinics to TTSH RC 3. Ages between 21 - 85 years 4. Duration of SAH to rehabilitation admission ≤6 months
Key exclusion criteria (1 listed)
- 1. No radiological evidence of SAH 2. Traumatic SAH 3. Previous diagnosis of SAH 4. Main reason for admission into TTSH RC was not for inpatient rehabilitation (e.g. wound care, medical or social admission)
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 |
|---|---|---|
| Inpatient RehabilitationObservational electronic records review study during inpatient rehabilitation | Other | Completed discharged hospital rehabilitation electronic record |
Primary outcome
Functional Independence Measure (FIM score)
Time frame: Within 72 hours of discharge from rehabilitation
The FIM, scored between 18 - 126, comprises of 18 items (motor and cognitive sub scores) which assesses a patient's degree of disability and indicates the degree of assistance required for activities of daily living. FIM scoring is widely used for functional scoring in patients with neurologic pathologies such as stroke or traumatic brain injury. Studies on its utility have shown high reliability, validity, and sensitivity for measuring functional ability and high consistency with other functional scales such as the Barthel Index
1 secondary outcome
FIM Change
Time frame: Within 72 hours of admission and discharge from rehabilitation
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 22 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Karen S Chua, MBBS FRCPE principal investigator
Tan Tock Seng Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Spontaneous, run by Tan Tock Seng Hospital at 2 sites in Singapore.
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 1 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 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
Functional Independence Measure (FIM score) (time frame: Within 72 hours of discharge from rehabilitation). 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 22 Apr 2020.