Clinical trial NCT02572999: Incidence and Risk Factors for Hospitalization-Associated Disability
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Decline
Hospitalization-associated Disability
Iatrogenic Disease
Keywords: Aged
Frail
Functional decline
Impairment
valvular heart disease
Cohort
risk factors
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2015-10-09
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization-associated Disability
timeFrame: Up to 30 days post-hospital discharge
Secondary outcomes:
measure: The six minutes walking distance test
timeFrame: Up to 30 days post-hospital discharge
measure: Five meter gait speed test
timeFrame: Up to 30 days post-hospital discharge
measure: Timed get-up and go test
timeFrame: Up to 30 days post-hospital discharge
measure: Peak extension torque measured at the right side and evaluated at 60° of knee flexion
timeFrame: Up to 30 days post-hospital discharge
measure: Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.
timeFrame: Up to 30 days post-hospital discharge
measure: Inappropriate medication prescribing
timeFrame: Up to 30 days post-hospital discharge
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Mieke Deschodt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.