- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07351526
Inpatient Post-Acute Rehabilitation For Patients in the Midwest: a Prospective Cohort Study of Clinical Characteristics and Process Outcomes
Rehabilitation improves health outcomes, reduces disability and improves quality of life. There is a significant and emerging body of international evidence to support the benefit and cost effectiveness of specialist rehabilitation services within a modern health service. The demand for rehabilitation services is growing with changes in populations and with the advances in health care and new interventions and technology.
Our overall aim is to explore the outcomes and clinical characteristics of adults who are admitted to a rehabilitation hospital in the Midwest region of Ireland during admission, at the time of their discharge and at 6 months.
Study Overview
Status
Detailed Description
Rehabilitation is a dynamic and critical component of the therapeutic continuum and one that is essential if patients are to regain or maintain their life roles, health status and quality of life after serious illness or injury.
The World Health Organisation (WHO) recommends in its definition that priority is given to ensure access, for those in need, to appropriate, timely, affordable and high-quality rehabilitation interventions.
Life expectancy is improving and the population of older persons is growing with increased demand for specialist rehabilitation services. This population is at increased risk for functional decline and increased demand for healthcare services. With older adults accounting for up to 24% of all ED attendees and an anticipated rise in this number, this places increased strain on the healthcare system
The aim of this study is to establish the demographic and clinical characteristics of adults in the Midwest referred, assessed and treated in St Ita's Rehabilitation Hospital in the Mid- West of lreland.
This study will inform on resource requirements of our rehabilitation facilities to ensure that the complexity of the patients are matched by the resources provided. We will also explore the benefits of rehabilitation across a broad range of conditions and evaluate the outcomes for patients including patient reported measures.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Munster
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Limerick, Munster, Ireland, V94 T9PX
- Recruiting
- School of Allied Health, University of Limerick
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Contact:
- Rose Galvin Professor, PhD
- Phone Number: +35361213081
- Email: rose.galvin@ul.ie
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Contact:
- Christina Hayes, PhD
- Phone Number: +35361213081
- Email: christina.hayes@ul.ie
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Principal Investigator:
- Orla Holmes, MB, Bch, BAO
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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:
- Patients aged 18 and over and admitted to a relevant rehabilitation unit with capacity to provide consent for inclusion.
Exclusion Criteria:
- Pregnant women and patients who are deemed not to have capacity to consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of functional decline
Time Frame: Baseline
|
The number of participants who experience functional decline or do not as measured by the Barthel Index (BI).
Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI.
The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.
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Baseline
|
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Incidence of functional decline
Time Frame: From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
|
The number of participants who experience functional decline or do not as measured by the Barthel Index (BI).
Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI.
The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.
|
From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
|
|
Incidence of Functional Decline
Time Frame: 6 Months
|
The number of participants who experience functional decline or do not as measured by the Barthel Index (BI).
Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI.
The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare use
Time Frame: 6 Months
|
Number of services that participants were in receipt of following discharge from rehabilitation services including; GP visits, unplanned Emergency Department attendance, Outpatient appointments.
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6 Months
|
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Polypharmacy level
Time Frame: Baseline
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Potentially inappropriate prescribing (PIP) and potentially omitted medications (POM) using the STOP START criteria.
The STOPP/START Screening tools are based on the STOPP/START Prescription criteria which consist of a set of inappropriate combinations of medicines and disease (STOPP) and a set of recommended treatments for given conditions (START).
There are 80 STOPP and 34 START criteria and they are grouped by physiological system e.g.
cardiovascular.
|
Baseline
|
|
Polypharmacy level
Time Frame: From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
|
potentially inappropriate prescribing (PIP) and potentially omitted medications (POM) using the STOP START criteria.
The STOPP/START Screening tools are based on the STOPP/START Prescription criteria which consist of a set of inappropriate combinations of medicines and disease (STOPP) and a set of recommended treatments for given conditions (START).
There are 80 STOPP and 34 START criteria and they are grouped by physiological system e.g.
cardiovascular.
|
From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
|
|
Polypharmacy level
Time Frame: 6 Months
|
potentially inappropriate prescribing (PIP) and potentially omitted medications (POM) using the STOP START criteria.
The STOPP/START Screening tools are based on the STOPP/START Prescription criteria which consist of a set of inappropriate combinations of medicines and disease (STOPP) and a set of recommended treatments for given conditions (START).
There are 80 STOPP and 34 START criteria and they are grouped by physiological system e.g.
cardiovascular.
|
6 Months
|
|
Frailty
Time Frame: From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
|
Participants will be reviewed at time of discharge from rehabilitation services as to level of frailty using both the clinical frailty scale (CFS) and the identification of seniors at risk (ISAR) frailty screening tools.
Both the clinical frailty scale and identification of seniors at risk were recorded at admission and again at discharge to evaluate change in frailty status over the hospital stay.
The combination of tools will aim to enable examination of how initial risk screening interacts with frailty status to influence long-term functional trajectories.
Higher scores on both the clinical frailty scale and identification of seniors at risk indicate higher levels of frailty and are often associated with worse outcomes.
The clinical frailty scale is a 9 point rating scale (1-9) with 9 indicating the highest level of frailty (terminally ill), the identification of seniors at risk is a 6 item screening tool with a score of 2 or greater indicating increased risk of frailty.
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From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
|
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Frailty
Time Frame: 6 months
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Participants will be reviewed at time of discharge from rehabilitation services as to level of frailty using both the clinical frailty scale (CFS) and the identification of seniors at risk (ISAR) frailty screening tools.
Both the Clinical frailty scale and Identification of seniors at risk were recorded at 6 month follow up to evaluate change in frailty status over the hospital stay.
The combination of tools will aim to enable examination of how initial risk screening interacts with frailty status to influence long-term functional trajectories.
Higher scores on both the clinical frailty scale and identification of seniors at risk indicate higher levels of frailty and are often associated with worse outcomes.
The clinical frailty scale is a 9 point rating scale (1-9) with 9 indicating the highest level of frailty (terminally ill), the identification of seniors at risk is a 6 item screening tool with a score of 2 or greater indicating increased risk of frailty.
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6 months
|
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Quality of life (EuroQoL-5 dimension 5 level questionnaire)
Time Frame: Baseline
|
A questionnaire to evaluate participants health-related quality of life, assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Higher scores indicate higher perception of health related quality of life.
Index score (0-1) with 1 being the best and visual analogue scores (0-100) with 100 being the highest rating of overall health.
|
Baseline
|
|
Quality of life (EuroQoL-5 dimension 5 level questionnaire)
Time Frame: From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
|
A questionnaire to evaluate participants health-related quality of life, assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Higher scores indicate higher perception of health related quality of life.
Index score (0-1) with 1 being the best and visual analogue scores (0-100) with 100 being the highest rating of overall health.
|
From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
|
|
Quality of life (EuroQoL-5 dimension 5 level questionnaire)
Time Frame: 6 Months
|
A questionnaire to evaluate participants health-related quality of life, assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Index score (0-1) with 1 being the best and visual analogue scores (0-100) with 100 being the highest rating of overall health.
|
6 Months
|
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Nursing Home Admission
Time Frame: 6 Months
|
Number of participants who were admitted to a nursing home or residential care facility following discharge from rehabilitation services.
|
6 Months
|
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Mortality
Time Frame: 6 Months
|
The number of participants who died following discharge from rehabilitation services.
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6 Months
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Falls
Time Frame: 6 Months
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Number of falls sustained post discharge from rehabilitation services.
|
6 Months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zhang S, Lin D, Wright ME, Swallow N. Acute Inpatient Rehabilitation Improves Function Independent of Comorbidities in Medically Complex Patients. Arch Rehabil Res Clin Transl. 2022 Jan 12;4(2):100178. doi: 10.1016/j.arrct.2022.100178. eCollection 2022 Jun.
- Wang H, Camicia M, DiVita M, Mix J, Niewczyk P. Early inpatient rehabilitation admission and stroke patient outcomes. Am J Phys Med Rehabil. 2015 Feb;94(2):85-96; quiz 97-100. doi: 10.1097/PHM.0000000000000226.
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
- 0164
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
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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