10-year Follow-up After Aortic Valve Replacement Surgery

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06255691

Acronym

AVR-10year

Enrollment

282

Registered

2024-02-13

Start date

2025-04-10

Completion date

2027-12-31

Last updated

2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Aortic Stenosis, Depressive Symptoms, Quality of Life

Keywords

aortic valve replacement, longitudinal study, patient reported outcome, symptoms of anxiety, health-related quality of life

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Experiences with health services	10 year follow-up	Open questions

Contacts

Primary ContactStein O Danielsen, PhD

steinove@oslomet.no4741368255

Backup ContactIrene Lie, PhD

Irene.lie@ous-hf.no99026729

Outcome results