Determinants of Rehabilitation Outcomes in Survivors of Primary Subarachnoid Haemorrhage (DETERMINESAH)

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage, Spontaneous
• Intervention / Treatment: Other: Inpatient Rehabilitation

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 Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 569766
    • Tan Tock Seng Hospital Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted acutely for inpatient rehabilitation from neurosurgical wards

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Completed discharged hospital rehabilitation electronic record; Completed discharged hospital rehabilitation electronic record of patients who underwent inpatient rehabilitation as part of routine clinical care.	Other: Inpatient Rehabilitation; Observational electronic records review study during inpatient rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 72 hours of discharge from rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIM Change	Difference between FIM discharge and admission	Within 72 hours of admission and discharge from rehabilitation

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Investigators: Principal Investigator: Karen S Chua, MBBS FRCPE, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: DSRB 2019/00594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No