Clinical Trial: Incidence and Risk Factors for Hospitalization-Associated Disability

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Universitaire Ziekenhuizen Leuven

Current 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.


Original Primary Outcome: Hospitalization-associated Disability [ Time Frame: Up to 30 days post-hospital discharge ]

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


Current Secondary Outcome:

  • 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 ]
    Isometric quadriceps strength will be measured using a dynamometer (Biodex system 4 pro; Enraf Nonius; Delft, The Netherlands)
  • 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 ]
    Isometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI)
  • Inappropriate medication prescribing [ Time Frame: Up to 30 days post-hospital discharge ]
    Inappropriate medication prescribing using the RASP-list (Rationalization of Home Medication by an Adjusted STOPP list in Older Patients)


Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: October 1, 2015
Date Started: October 2015
Date Completion:
Last Updated: April 10, 2017
Last Verified: March 2017