Functional DeclineNCT02572999
Incidence and Risk Factors for Hospitalization-Associated Disability
An observational study of Functional Decline and Hospitalization-associated Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This prospective cohort study aims to determine the incidence of hospitalization-associated disability and its association with risk factors at the patient level and with care and hospital processes. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Decline, Hospitalization-associated Disability, Iatrogenic Disease
- What is being tested?
- Not applicable (observational design)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Dec 2016
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients aged 70 years and older admitted for elective heart valve surgery (replacement, repair or combined with CABG) or if admitted for elective transcatheter aortic valve implantation, or if a patient presents with symptomatic moderate to severe valvular heart disease on hospital admission.
Who may be able to join
- Aged 70 years or older
- Admitted for elective heart valve surgery (replacement, repair or combined with CABG) or if admitted for elective transcatheter aortic valve implantation, or if a patient presents with symptomatic moderate to severe valvular heart disease on hospital admission as evidenced by moderate to severe valve regurgitation (≥ 2/4) or aortic valve area ≤ 1cm2 or mitral valve area ≤ 1.5cm2 and if one of the following symptoms is present: heart failure, decreased exercise tolerance, (exertional) dyspnea, (exertional) angina, (exertional) syncope
- Dutch speaking
Who cannot join
- Life expectancy less than 6 months
- Expected length of stay less than 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Risk Factors for Hospitalization-Associated Disability (HAD) and Its Association With Hospital and Care Processes in Patients With Valvular Heart Disease
This prospective cohort study aims to determine the incidence of hospitalization-associated disability and its association with risk factors at the patient level and with care and hospital processes. For this, patients aged 70 years or older admitted for elective valve surgery or elective transcatheter aortic valve implantation or as a result of symptomatic moderate to severe valvular heart disease will be consecutively included from 01 October 2015 to 29 February 2016.
- Being tested
- Not applicable (observational design)
- Keywords
- Aged, Frail, Functional decline, Impairment, valvular heart disease, Cohort, risk factors
- Medical subject headings
- Iatrogenic Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable (observational design)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Valvular heart disease | All patients aged 70 years or older, consecutively admitted for elective heart valve surgery or if admitted for elective transcatheter aortic valve implantation, or if a patient presents with symptomatic moderate to severe valvular heart disease on hospital admission as evidenced by moderate to severe valve regurgitation or stenosis will be included in this cohort. Participants will be observed up to 30 days post-hospital discharge Receives: Procedure: Not applicable (observational design) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization-associated Disability
The loss of ability to complete one of the basic ADLs independently between baseline and hospital discharge.
Measured: Up to 30 days post-hospital discharge
Secondary outcomes (6)
The six minutes walking distance test
Measured: Up to 30 days post-hospital discharge
Five meter gait speed test
Measured: Up to 30 days post-hospital discharge
Timed get-up and go test
Measured: Up to 30 days post-hospital discharge
Peak extension torque measured at the right side and evaluated at 60° of knee flexion
Isometric quadriceps strength will be measured using a dynamometer (Biodex system 4 pro; Enraf Nonius; Delft, The Netherlands)
Measured: Up to 30 days post-hospital discharge
Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.
Isometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI)
Measured: Up to 30 days post-hospital discharge
Inappropriate medication prescribing
Inappropriate medication prescribing using the RASP-list (Rationalization of Home Medication by an Adjusted STOPP list in Older Patients)
Measured: Up to 30 days post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DeclineStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Mieke Deschodt, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572999
- Sponsor's protocol ID
- C22/15/028/01
- Status last verified
- Mar 2017
- First submitted
- 1 Oct 2015
- Last updated
- 11 Apr 2017
- Results posted
- No
Publications
Jonckers M, Van Grootven B, Willemyns E, Hornikx M, Jeuris A, Dubois C, Herregods MC, Deschodt M. Hospitalization-associated disability in older adults with valvular heart disease: incidence, risk factors and its association with care processes. Acta Cardiol. 2018 Jan 4;73(6):566-572. doi: 10.1080/00015385.2017.1421300.
PubMed 29301463
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Hospitalization-Associated Disability (HAD) and Its Association With Hospital and Care Processes in Patients With Valvular Heart Disease
- ClinicalTrials.gov ID
- NCT02572999
- Acronym / sponsor ID
- C22/15/028/01
- Keywords
- Aged, Frail, Functional decline, Impairment, valvular heart disease, Cohort, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Oct 2015 (estimated)
- 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.
This prospective cohort study aims to determine the incidence of hospitalization-associated disability and its association with risk factors at the patient level and with care and hospital processes. For this, patients aged 70 years or older admitted for elective valve surgery or elective transcatheter aortic valve implantation or as a result of symptomatic moderate to severe valvular heart disease will be consecutively included from 01 October 2015 to 29 February 2016.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valvular heart disease | – | Procedure: Not applicable (observational design)All patients aged 70 years or older, consecutively admitted for elective heart valve surgery or if admitted for elective transcatheter aortic valve implantation, or if a patient presents with symptomatic moderate to severe valvular heart disease on hospital admission as evidenced by moderate to severe valve regurgitation or stenosis will be included in this cohort. Participants will be observed up to 30 days post-hospital discharge |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients aged 70 years and older admitted for elective heart valve surgery (replacement, repair or combined with CABG) or if admitted for elective transcatheter aortic valve implantation, or if a patient presents with symptomatic moderate to severe valvular heart disease on hospital admission.
Key inclusion criteria (3 listed)
- Aged 70 years or older
- Admitted for elective heart valve surgery (replacement, repair or combined with CABG) or if admitted for elective transcatheter aortic valve implantation, or if a patient presents with symptomatic moderate to severe valvular heart disease on hospital admission as evidenced by moderate to severe valve regurgitation (≥ 2/4) or aortic valve area ≤ 1cm2 or mitral valve area ≤ 1.5cm2 and if one of the following symptoms is present: heart failure, decreased exercise tolerance, (exertional) dyspnea, (exertional) angina, (exertional) syncope
- Dutch speaking
Key exclusion criteria (2 listed)
- Life expectancy less than 6 months
- Expected length of stay less than 48 hours
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 |
|---|---|---|
| Not applicable (observational design) | Procedure or surgery | Valvular heart disease |
Primary outcome
Hospitalization-associated Disability
Time frame: Up to 30 days post-hospital discharge
The loss of ability to complete one of the basic ADLs independently between baseline and hospital discharge.
6 secondary outcomes
The six minutes walking distance test
Time frame: Up to 30 days post-hospital discharge
Five meter gait speed test
Time frame: Up to 30 days post-hospital discharge
Timed get-up and go test
Time frame: Up to 30 days post-hospital discharge
Peak extension torque measured at the right side and evaluated at 60° of knee flexion
Time frame: Up to 30 days post-hospital discharge
Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.
Time frame: Up to 30 days post-hospital discharge
Inappropriate medication prescribing
Time frame: Up to 30 days post-hospital discharge
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 11 Apr 2017.
- Derived from this study: PubMed 29301463Jonckers M, Van Grootven B, Willemyns E, Hornikx M, Jeuris A, Dubois C, Herregods MC, Deschodt M. Hospitalization-associated disability in older adults with valvular heart disease: incidence, risk factors and its association with care processes. Acta Cardiol. 2018 Jan 4;73(6):566-572. doi: 10.1080/00015385.2017.1421300.
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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.
Mieke Deschodt, PhD principal investigator
KU Leuven
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 Functional Decline and Hospitalization-associated Disability, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 inclusion and 2 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 11 Apr 2017. 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 Belgium. 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?
Hospitalization-associated Disability (time frame: Up to 30 days post-hospital discharge). 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 NCT02572999, which also lists 1 linked publication.
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 11 Apr 2017.