Incidence and Risk Factors for Hospitalization-Associated Disability

NCT ID: NCT02572999

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Functional Decline Hospitalization-associated Disability Iatrogenic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Not applicable (observational design)

Intervention Type PROCEDURE

Interventions

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Not applicable (observational design)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Life expectancy less than 6 months
* Expected length of stay less than 48 hours
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mieke Deschodt, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 29301463 (View on PubMed)

Other Identifiers

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C22/15/028/01

Identifier Type: -

Identifier Source: org_study_id

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