NCT02572999

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 11, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

October 1, 2015

Last Update Submit

April 10, 2017

Conditions

Functional DeclineHospitalization-associated DisabilityIatrogenic Disease

Keywords

AgedFrailFunctional declineImpairmentvalvular heart diseaseCohortrisk factors

Outcome Measures

Primary Outcomes (1)

  • Hospitalization-associated Disability

    The loss of ability to complete one of the basic ADLs independently between baseline and hospital discharge.

    Up to 30 days post-hospital discharge

Secondary Outcomes (6)

  • The six minutes walking distance test

    Up to 30 days post-hospital discharge

  • Five meter gait speed test

    Up to 30 days post-hospital discharge

  • Timed get-up and go test

    Up to 30 days post-hospital discharge

  • Peak extension torque measured at the right side and evaluated at 60° of knee flexion

    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.

    Up to 30 days post-hospital discharge

  • +1 more secondary outcomes

Study Arms (1)

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

Procedure: Not applicable (observational design)

Interventions

Not applicable (observational design)PROCEDURE
Valvular heart disease

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Life expectancy less than 6 months
  • Expected length of stay less than 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 29301463DERIVED

MeSH Terms

Conditions

Iatrogenic DiseaseHeart Valve Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Mieke Deschodt, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 9, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

April 11, 2017

Record last verified: 2017-03

Locations

BE(1)