Clinical trial NCT06255691: 10-year Follow-up After Aortic Valve Replacement Surgery
Official title: 10-year Follow-up After 24/7-phone Support After Aortic Valve Replacement Surgery in Early Rehabilitation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Stenosis
Anxiety
Depressive Symptoms
Quality of Life
Keywords: aortic valve replacement
longitudinal study
patient reported outcome
symptoms of anxiety
health-related quality of life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
First posted: 2024-02-13
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 year follow-up of the participants in the AVrRe study

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptoms of anxiety and depression
timeFrame: 10 year follow-up
measure: Health related quality of life
timeFrame: 10 year follow-up
Secondary outcomes:
measure: Experiences with health services
timeFrame: 10 year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: OsloMet
name: Stein Ove O Danielsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: