ASQoL Study
Research type
Research Study
Full title
Protocol for a prospective cohort study to develop and validate AScites Quality of Life questionnaire (ASQoL)
IRAS ID
243465
Contact name
Stewart Mcdonald
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/05/11, Data Protection Registration
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study will be undertaken in 15 UK centres to evaluate a short, disease-targeted, Health Related Quality of Life (HRQoL)questionnaire in patients with ascites due to chronic liver diseases referred to as “ the AScites Quality of Life questionnaire (ASQoL)”. At present there is no such tool available.
Questionnaire items have been selected through patient interviews, extensive literature review and a focus group involving patients, methodologists, statisticians and hepatologists.
The ASQoL questionnaire will initially be completed (baseline visit 1) by patients attending hospitals for their routine appointments or as in-patients and then further completed (2 weeks later) at home depending upon the patients whereabouts. The 2 week visit will be used to undertake reliability and responsiveness checks. A further visit will then be undertaken between months 2-5 (visit 2) coinciding with the patients next routine appointment where they will complete the questionnaire again. At each visit the patients will also be asked to complete 2 other questionnaires (the SF12 and EQ5D). The data collected across these two questionnaires will be used and combined with the data collected in the ASQoL questionnaire to provide comprehensive data on a patients QoL. At each visit a researcher will also assess the patients frailty score using a validated frailty assessment tool. Routine Model for End Stage Liver Disease (MELD) and United Kingdom Model for End Stage Liver Disease (UKELD) will also be calculated. This additional data will be used to look at predictive scores of mortality that maybe detected in the ASQoL scores.
REC name
Social Care REC
REC reference
18/IEC08/0022
Date of REC Opinion
12 Jun 2018
REC opinion
Favourable Opinion