Incidence and Risk Factors for Hospitalization-Associated Disability

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

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.

Study Overview

• Status: Completed
• Conditions: Iatrogenic Disease; Functional Decline; Hospitalization-associated Disability
• Intervention / Treatment: Procedure: Not applicable (observational design)

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitaire Ziekenhuizen Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Valvular heart disease; 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

Procedure: Not applicable (observational design)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The six minutes walking distance test		Up to 30 days post-hospital discharge
Five meter gait speed test		Up to 30 days post-hospital discharge
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	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
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
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Mieke Deschodt, PhD, KU Leuven

Publications and helpful links

General Publications

• 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 4:1-7. doi: 10.1080/00015385.2017.1421300. Online ahead of print.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Functional decline; risk factors; Cohort; Impairment; Aged; Frail; valvular heart disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease
• Other Study ID Numbers: C22/15/028/01