Development of a QoL assessment for patients undergoing TAVI
Research type
Research Study
Full title
Development of a Quality of Life assessment for patients undergoing Transcatheter Aortic Valve Implantation.
IRAS ID
128188
Contact name
Fabia H I Bass Fagan
Contact email
Sponsor organisation
City University London
Research summary
Transcatheter Aortic Valve Implantation (TAVI) is indicated as a less invasive treatment option for patients with severe, symptomatic Aortic Stenosis (AS). AS is a chronic, progressive disease; severe symptomatic AS is associated with significant morbidity and mortality, producing a number of symptoms including shortness of breath, angina and heart failure, leading to a poor prognosis.
Traditionally patients with AS are treated with Surgical Aortic Valve Replacement (SAVR), however due to the severity of AS increasing with advanced age, patients often have varying co-morbidities and SAVR is no longer an option for them. TAVI offers a minimally invasive and safer procedure. It involves implanting a stent-based prosthesis though percutaneous intervention. Patients who have undergone TAVI have shown to have a more rapid recovery rate to the minimally invasive nature of the procedure. TAVI has shown to reduce mortality rates and patients will have a fewer repeat hospital admissions, thus enhancing their Quality of Life.
Currently the only research surrounding Quality of Life within the TAVI population are quantitative studies, using generic or non-disease specific Quality of Life assessments. No attempt has been made to create a disease specific quality of life assessment, nor has there been a qualitative research study. The ability to evaluate Quality of Life post TAVI is particularly significant in the elderly population it was developed within due to their often extensive comorbidities and a disease specific Quality of Life assessment can offer an effective way in which to measure the effectiveness of treatment, as well as aiding decision making within the multi-disciplinary team when considering the use of TAVI.
Aims:
1. To explore the participants quality of life pre and post TAVI.
2. To develop a TAVI specific Quality of Life assessment
3. To validate the research findings amongst a proportion of the research participants in the form of member checking.
The aim is to recruit a sample of 30 participants over a period of 18 months within in a North-East London NHS Trust. Data will be collected through a series of individual recorded interviews; pre-procedure, one month post-procedure and 90 days post-procedure. Each interview will last between one to one and a half hours. Data will be analysed through transcription of interviews and grouping and categorising concepts using grounded theory methodology.REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1023
Date of REC Opinion
18 Sep 2013
REC opinion
Further Information Favourable Opinion