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Completed

NCT Number: NCT02572999

Incidence and Risk Factors for Hospitalization-Associated Disability

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.

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Key information

Conditions

Functional Decline Cardiovascular Diseases Disease Attributes Heart Diseases Heart Valve Diseases Hospitalization-associated Disability Iatrogenic Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable (observational design)

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. The six minutes walking distance test

    Time frame: Up to 30 days post-hospital discharge

  2. Five meter gait speed test

    Time frame: Up to 30 days post-hospital discharge

  3. Timed get-up and go test

    Time frame: Up to 30 days post-hospital discharge

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2015
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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