- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06842420
Model Development and Temporal Validation of the Predictive Factors for Return to Work After Stroke Rehabilitation
Study Overview
Status
Conditions
Detailed Description
Background Return to work post stroke is a key milestone for many survivors of stroke; however, many cannot achieve this goal. Based on the previous work by Tay et al, independent predictive factors were identified for return to work post inpatient stroke rehabilitation. In further works by Koh and Tay with the same dataset put through different models such as LASSO-Full, Lasso-Routine, ElasticNet-Full, etc suggests that the good discrimination performance of the return-to-work prediction models during internal validation supports a multisite, external validation study. Performing a temporal validation study is the interim step. A smaller part of the dataset could be used to further train the development model.
Significant economic costs are incurred because of stroke, which do not include further economic costs from the downstream loss of earnings and caregiver burden. Existing prediction models of return-to-work have area under the receiver operating characteristic curves (AUROCs) between 0.65 and 0.80. However, these models have not been assessed for calibration or clinical utility. No externally validated prediction model exists for return-to-work after stroke. There are advantages to having a prediction model. One of the concerns of patients and their families involve the loss of income as a result of stroke. The prediction model would help to prognosticate, as well as assist to set appropriate rehabilitation goals for the patient. Suitable patients can be directed to return to work services, if necessary.
Health is related to one's employment and financial position. Being able to return to gainful employment can result in better general and mental health5. People with disabilities employed in the past year reported better general and mental health than their peers with the same disabilities who were unemployed.
This study could be completed in 1 to 2 years and a prospective study involving external validation can be simultaneously performed with NUHS collaborators over 2 to 2.5 years. Both projects could be published in the next 2 to 3 years upon obtaining the grant for the temporal validation study. Thereafter, a Return to work calculator could be designed and launched in the next 4 years.
Hypothesis This study seeks to collect 1375 patient data who had completed inpatient stroke rehabilitation between the time periods of 2018-2025. We seek to further train our development model and to perform a temporal validation on this model.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Singapore, Singapore, 529889
- Changi General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Completed inpatient stroke rehabilitation in CGH
- Diagnosis of a first ever stroke
- Patients who were working prior to stroke
- Consent given
Exclusion Criteria:
- Not first ever stroke
- Did not require inpatient stroke rehabilitation
- Not working prior to stroke
- No consent obtained
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Stroke patients who had completed inpatient stroke rehabilitation between 2018-2025
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Return to work
Time Frame: 1 year and 2 years
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Return to work at 1 year and 2 years post stroke
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1 year and 2 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/2526
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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