Incidence and Risk Factors for Hospitalization-Associated Disability (HAD) and Its Association With Hospital and Care Processes in Patients With Valvular Heart Disease

Universitaire Ziekenhuizen KU Leuven1 site in 1 country80 target enrollmentOctober 2015

ConditionsFunctional Decline Hospitalization-associated Disability Iatrogenic Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Functional Decline
Sponsor: Universitaire Ziekenhuizen KU Leuven
Enrollment: 80
Locations: 1
Primary Endpoint: Hospitalization-associated Disability
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

December 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Universitaire Ziekenhuizen KU Leuven

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Timed get-up and go test(Up to 30 days post-hospital discharge)
Inappropriate medication prescribing(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)
Peak extension torque measured at the right side and evaluated at 60° of knee flexion(Up to 30 days post-hospital discharge)
Five meter gait speed test(Up to 30 days post-hospital discharge)
The six minutes walking distance test(Up to 30 days post-hospital discharge)