Incidence and Risk Factors for Hospitalization-Associated Disability

Iatrogenic Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572999
• Other study ID #: C22/15/028/01
• Status: Completed
• Phase: N/A
• First received: October 1, 2015
• Last updated: April 10, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Decline
• Heart Valve Diseases
• Hospitalization-associated Disability
• Iatrogenic Disease

Intervention

Procedure:
• Not applicable (observational design)

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The six minutes walking distance test		Up to 30 days post-hospital discharge
Secondary	Five meter gait speed test		Up to 30 days post-hospital discharge
Secondary	Timed get-up and go test		Up to 30 days post-hospital discharge
Secondary	Peak extension torque measured at the right side and evaluated at 60° of knee flexion	Isometric quadriceps strength will be measured using a dynamometer (Biodex system 4 pro; Enraf Nonius; Delft, The Netherlands)	Up to 30 days post-hospital discharge
Secondary	Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.	Isometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI)	Up to 30 days post-hospital discharge
Secondary	Inappropriate medication prescribing	Inappropriate medication prescribing using the RASP-list (Rationalization of Home Medication by an Adjusted STOPP list in Older Patients)	Up to 30 days post-hospital discharge