10-year Follow-up After Aortic Valve Replacement Surgery (AVR-10year)

University of Oslo (UIO)

Status: Begins enrollment in 8 months

Conditions: Depressive Symptoms; Quality of Life; Anxiety; Aortic Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT06255691

23596

Details and patient eligibility

About

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.

Full 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.

Enrollment: 282 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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