Approach-IS II
Research type
Research Study
Full title
Assessment of Patterns of Patient-reported Outcomes in Adults with Congenital Heart disease – International Study II
IRAS ID
269823
Contact name
Philip Moons
Contact email
Sponsor organisation
KU Leuven
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Congenital heart disease (CHD) is the most common birth defect, occurring in approximately 9 per 1,000 births. Due to successful infant heart surgery, most children now survive into adulthood. As the adult group grows understanding outcomes and expectations, from the patients’ perspective, is required to advance care provision. Second, as adults with CHD are ageing, understanding how disability and frailty affect prognosis will enable us to map their specific healthcare needs.
The APPROACH IS II study is an international, multi-centred study that aims to:
Part 1: explore differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) amongst adults with CHD from low, middle, and high-income countries
Part 2: To describe the profile and healthcare needs of a subgroup of older adults with CHD, with a focus on frailty.
Patients will be recruited at the adult CHD outpatient clinic of the Freeman Hospital, Newcastle upon Tyne, having been sent a prior letter of invitation, using a consecutive sampling technique. Patients recruited to Part 1 will consent to demographic and clinical data collection and will complete a set of validated questionnaires and some specifically developed questionnaires, in their native language. They may complete the questionnaires online or on paper. Patients recruited to Part 2 will consent to demographic and clinical data collection and will complete a set of validated questionnaires, undertake a short walk test and record their muscle grip strength with a hand held dynamometer. Data collection will take place on the same afternoon as their routine clinic appointment under the supervision of the Adult CHD research nurse.
Data will be submitted to the lead centre (KU Leuven). Statistical analysis will be undertaken to investigate geographical variability and frailty as predictors of PROMs and PREMs. A period of 12 months is foreseen for data-entry and analysis.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0259
Date of REC Opinion
10 Sep 2019
REC opinion
Favourable Opinion