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Individualised Follow-up After Valve Surgery (INVOLVE)

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ClinicalTrials.gov Identifier: NCT03053778
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : May 23, 2018
Sponsor:
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
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
Estimated Primary Completion Date : June 2, 2018
Estimated Study Completion Date : December 31, 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 [ 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



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

Inclusion Criteria:

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

Exclusion Criteria:


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


Contacts
Contact: Britt Borregaard, MPQM britt.borregaard@rsyd.dk
Contact: Jacob E Møller, Professor Jacob.Moeller1@rsyd.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Britt Borregaard, MPQM       britt.borregaard@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Britt Borregaard Odense University Hospital

Responsible Party: Britt Borregaard, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03053778     History of Changes
Other Study ID Numbers: 222
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Readmission
Early follow-up
Heart valves
Heart valve surgery

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases