Incidence and Risk Factors for Hospitalization-Associated Disability

Study 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.

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

Conditions
-----------------
Functional Decline, Hospitalization-associated Disability, Iatrogenic Disease

Intervention / Treatment
-----------------
* Procedure: Not applicable (observational design)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Valvular heart disease<br>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)<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, Frail, Functional decline, Impairment, valvular heart disease, Cohort, risk factors