RehabilitationNCT07351526
Inpatient Post-Acute Rehabilitation For Patients in the Midwest: a Prospective Cohort Study of Clinical Characteristics and Process Outcomes
An observational study of Rehabilitation and Frailty, run by University of Limerick at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation, Frailty, Complex Patients in Rehabilitation Phase
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 22 Feb 2025to 22 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults admitted to St Ita's Rehabilitation Hospital from February 2025 to February 2026 (inclusive) will be considered eligible for participation in the study, if they meet the inclusion criteria.
Who may be able to join
- Patients aged 18 and over and admitted to a relevant rehabilitation unit with capacity to provide consent for inclusion.
Who cannot join
- Pregnant women and patients who are deemed not to have capacity to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
School of Allied Health, University of Limerick
Limerick, Munster, V94 T9PX
Rose Galvin Professor, PhD, +35361213081, rose.galvin@ul.ie
Christina Hayes, PhD, +35361213081, christina.hayes@ul.ie
About this study
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.
Read the 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.
- Keywords
- rehabilitation, complexity, rehabilitation outcomes
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of functional decline
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.
Measured: Baseline
Incidence of functional decline
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.
Measured: From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
Incidence of Functional Decline
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.
Measured: 6 Months
Secondary outcomes (12)
Healthcare use
Number of services that participants were in receipt of following discharge from rehabilitation services including; GP visits, unplanned Emergency Department attendance, Outpatient appointments.
Measured: 6 Months
Polypharmacy level
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.
Measured: Baseline
Polypharmacy level
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.
Measured: From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
Polypharmacy level
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.
Measured: 6 Months
Frailty
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.
Measured: From the date on inception into the study until the date of discharge from hospital, assessed up to 6 months
Frailty
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.
Measured: 6 months
Quality of life (EuroQoL-5 dimension 5 level questionnaire)
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.
Measured: Baseline
Quality of life (EuroQoL-5 dimension 5 level questionnaire)
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.
Measured: 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)
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.
Measured: 6 Months
Nursing Home Admission
Number of participants who were admitted to a nursing home or residential care facility following discharge from rehabilitation services.
Measured: 6 Months
Mortality
The number of participants who died following discharge from rehabilitation services.
Measured: 6 Months
Falls
Number of falls sustained post discharge from rehabilitation services.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start22 Feb 2025
- Primary completion22 Sep 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351526
- Sponsor's protocol ID
- 0164
- Status last verified
- Oct 2025
- First submitted
- 8 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data collected during this study may be shared with approved researchers for the purpose of future research projects. Any data shared will be fully anonymised prior to release, with all direct and indirect identifiers removed to ensure that no participant can be identified. Only anonymised datasets will be made available, and these will be shared securely and solely for ethically approved research purposes.
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.
PubMed 35756989Wang 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.
PubMed 25569470
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Post-Acute Rehabilitation For Patients in the Midwest: a Prospective Cohort Study of Clinical Characteristics and Process Outcomes
- ClinicalTrials.gov ID
- NCT07351526
- Acronym / sponsor ID
- 0164
- Keywords
- rehabilitation, complexity, rehabilitation outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 22 Sep 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults admitted to St Ita's Rehabilitation Hospital from February 2025 to February 2026 (inclusive) will be considered eligible for participation in the study, if they meet the inclusion criteria.
Key inclusion criteria (1 listed)
- Patients aged 18 and over and admitted to a relevant rehabilitation unit with capacity to provide consent for inclusion.
Key exclusion criteria (1 listed)
- Pregnant women and patients who are deemed not to have capacity to consent.
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
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.
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.
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.
12 secondary outcomes
Healthcare use
Time frame: 6 Months
Polypharmacy level
Time frame: 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
Polypharmacy level
Time frame: 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
Frailty
Time frame: 6 months
Quality of life (EuroQoL-5 dimension 5 level questionnaire)
Time frame: 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
Quality of life (EuroQoL-5 dimension 5 level questionnaire)
Time frame: 6 Months
Nursing Home Admission
Time frame: 6 Months
Mortality
Time frame: 6 Months
Falls
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 35756989Zhang 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.
- Background: PubMed 25569470Wang 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.
- Irish Society of physicians in Geriatric medicine strategy for rehabilitation for older people in IrelandLink provided by the sponsor.
- World Health Organisation fact sheet - rehabilitationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual patient data collected during this study may be shared with approved researchers for the purpose of future research projects. Any data shared will be fully anonymised prior to release, with all direct and indirect identifiers removed to ensure that no participant can be identified. Only anonymised datasets will be made available, and these will be shared securely and solely for ethically approved research purposes.
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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.
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 Rehabilitation and Frailty, run by University of Limerick at 1 site in Ireland.
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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of functional decline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07351526, which also lists 2 linked publications.
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 20 Jan 2026.