Incidence and Risk Factors for Hospitalization-Associated Disability

Completed

• Conditions: Functional Decline; Iatrogenic Disease; Hospitalization-associated Disability
• Interventions: Procedure: Not applicable (observational design)

• Registration Number: NCT02572999
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Primary Completion: 2016-03
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Valvular heart disease	Not applicable (observational design)	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

Primary Outcome Measures

Name	Time	Method
Hospitalization-associated Disability	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 Outcome Measures

Name	Time	Method
Inappropriate medication prescribing	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)
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	Isometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI)
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	Isometric quadriceps strength will be measured using a dynamometer (Biodex system 4 pro; Enraf Nonius; Delft, The Netherlands)
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

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium