NCT03053778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,414

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

February 8, 2017

Last Update Submit

July 30, 2018

Conditions

Heart Valve DiseasesSurgeryReadmission

Keywords

ReadmissionEarly follow-upHeart valvesHeart valve surgery

Outcome Measures

Primary Outcomes (1)

  • Reduction of readmission

    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

    Up to two years

Secondary Outcomes (4)

  • Differences in costs between the two groups

    Up to three years

  • Quality of Life and associations with readmission

    Up to three years

  • The effect of a Heart valve Clinic on patient-reported outcomes

    Up to three years

  • Frailty status after Heart valve surgery

    Up to two years

Study Arms (1)

Intervention

EXPERIMENTAL

Early follow-up after discharge

Other: Early follow-up

Interventions

Early follow-upOTHER

Early follow-up until 4 weeks after discharge

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Britt Borregaard

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2017

First Posted

February 15, 2017

Study Start

November 1, 2016

Primary Completion

June 2, 2018

Study Completion

June 2, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

DK(1)