10-year Follow-up After Aortic Valve Replacement Surgery

Anxiety Clinical Trial

— AVR-10year  

Official title:

10-year Follow-up After 24/7-phone Support After Aortic Valve Replacement Surgery in Early Rehabilitation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06255691
• Other study ID #: 23596
• Status: Not yet recruiting
• Start date: April 10, 2025
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: Stein O Danielsen, PhD
• Phone: 4741368255
• Email: steinove[@]oslomet.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with the health services (PREMS). 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 repeat the survey on symtoms on anxiety and depresion using Hospital Anxiety and depression Scale (HADS), health-related quality of life (EQ-5D) and questions about experiences with the health services.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 282
• Est. completion date: December 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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Exclusion Criteria:

Patients not alive after the AVRre study

Related Conditions & MeSH terms

• Anxiety
• Aortic Stenosis
• Aortic Valve Stenosis
• Depression
• Depressive Symptoms
• Quality of Life

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Oslo Metropolitan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of anxiety and depression	Symptoms of anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)	10 year follow-up
Primary	Health related quality of life	EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life.	10 year follow-up
Secondary	Experiences with health services	Open questions	10 year follow-up