- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06255691
10-year Follow-up After Aortic Valve Replacement Surgery (AVR-10year)
10-year Follow-up After 24/7-phone Support After Aortic Valve Replacement Surgery in Early Rehabilitation Study
Study Overview
Status
Conditions
Detailed Description
"The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre) was a prospective, randomized controlled study (RSC) Including 286 patients after AVR from 2015 til 2017, NCT02522663. The results reported in international publications showed reduced symptoms on anxiety the first month after AVR.
Reduction of anxiety revealed to be an important aim for the intervention. We found that symptoms of anxiety in the early rehabilitation phase after discharge following surgical aortic valve replacement phase was significantly reduced.
There is a lack of data on patients self-reported outcome on symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with health services. In this 10-years follow-up study on patients alive from the study named "The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre)" NCT02522663 we will conduct a survey on symtoms of anxiety and depresion using Hospital Anxiety and depression Scale (HADS), quality of life (EQ-5D) and questions about experiences with health services.
The results of the planned 10-years follow-up may give guidance in how to allocate health resources and planning for and follow-up of patients after heart surgery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stein O Danielsen, PhD
- Phone Number: 4741368255
- Email: steinove@oslomet.no
Study Contact Backup
- Name: Irene Lie, PhD
- Phone Number: 99026729
- Email: Irene.lie@ous-hf.no
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Treatment with AVR (biological or mechanical) single, AVR (b or m)+aortocoronary bypass, AVR (b or m)+supra coronary tube graft Can understand, speak and write native Language (norwegian), and be able to fill in the questionnaires
-
Exclusion Criteria:
Patients not alive after the AVRre study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of anxiety and depression
Time Frame: 10 year follow-up
|
Symptoms of anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
|
10 year follow-up
|
Health related quality of life
Time Frame: 10 year follow-up
|
EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life.
|
10 year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experiences with health services
Time Frame: 10 year follow-up
|
Open questions
|
10 year follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stein Ove O Danielsen, PhD, OsloMet
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23596
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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