PAH/CTEPH Qualifying Physical Functioning
Research type
Research Study
Full title
PAH and CTEPH physical functioning qualitative research
IRAS ID
315784
Contact name
David Kiely
Contact email
Sponsor organisation
Janssen - Johnson & Johnson Pharmaceuticals
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Actelion are a subsidiary of Janssen, a Johnson & Johnson Pharmaceutical Company and will be sponsoring the study, they will be referred to as 'Actelion' throughout application.
Actelion would like to conduct a cross-sectional, non-interventional study that will involve telephone interviews with 30 adult patients who have a confirmed diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH).
The aim of the study is to identify physical functioning concepts that are meaningful and relevant to patients with regard to their PAH/CTEPH experience and how these could be measured in future clinical trials.
The study team at the hospital site will screen patients to identify those that are eligible to participate. The study team will then contact the identified patients to enquire about whether they are interested in participating in the study. Eligible patients that are interested in participating will then be provided with either a paper copy of the informed consent form and patient information sheet or an electronic copy depending on their preference.
Consenting patients will be provided with a patient questionnaire and have clinical data collected from medical records by hospital research teams. Following this the patient will be invited to participate in an interview to identify concepts of physical functioning that would be meaningful to them given their disease.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0166
Date of REC Opinion
29 Sep 2022
REC opinion
Further Information Favourable Opinion