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Individualised Follow-up After Valve Surgery (INVOLVE)

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ClinicalTrials.gov Identifier: NCT03053778
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
Britt Borregaard, Odense University Hospital

Brief Summary:

This study aims to investigate the effect of an intervention consisting of early, individualised outpatient follow-up after heart valve surgery on unplanned readmissions and death within 180-days after discharge.

Furthermore, Health economics and health-related quality of life will be investigated.

Condition or disease Intervention/treatment Phase
Heart Valve Diseases Surgery Readmission Other: Early follow-up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1414 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Individualised Follow-up After Valve Surgery
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : June 2, 2018
Actual Study Completion Date : June 2, 2018

Arm Intervention/treatment
Experimental: Intervention
Early follow-up after discharge
Other: Early follow-up
Early follow-up until 4 weeks after discharge

Primary Outcome Measures :
  1. Reduction of readmission [ Time Frame: Up to two years ]
    Reduction of readmission. a controlled prospective intervention trial comparing readmission rates and all-cause mortality in patients undergoing individualized follow-up with a historical control Group. A propensity matching will be performed

Secondary Outcome Measures :
  1. Differences in costs between the two groups [ Time Frame: Up to three years ]
    Health economics as measured by differences in the two groups. Further more a cost-utility analysis of cost and quality of life. The cost utility analysis is measured with a questionnaire

  2. Quality of Life and associations with readmission [ Time Frame: Up to three years ]
    Symptoms of health related quality of life measured with a questionnaire

  3. The effect of a Heart valve Clinic on patient-reported outcomes [ Time Frame: Up to three years ]
    Symptoms of disease specific quality of life measured with a questionnaire

  4. Frailty status after Heart valve surgery [ Time Frame: Up to two years ]
    Measuring of frailty status at discharge and associations to other outcomes

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient having Heart Valve Surgery at Odense University Hospital, Denmark

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053778

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Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Britt Borregaard Odense University Hospital
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Responsible Party: Britt Borregaard, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03053778    
Other Study ID Numbers: 222
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Britt Borregaard, Odense University Hospital:
Early follow-up
Heart valves
Heart valve surgery
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases