TY - JOUR
T1 - The RISE study protocol
T2 - resilience impacted by positive stressful events for people with cystic fibrosis
AU - van der Heijden, Els
AU - van den Bor, Rutger M
AU - van der Ent, Cornelis K
AU - Nijhof, Sanne L
AU - van der Laan, Sabine E I
N1 - Funding Information:
We have been awarded a grant for this research: Corno Fonds Onderzoek Subsidie 2022 by the Dutch Cystic Fibrosis Society. Both people with CF and scientists individually reviewed and assessed the research plan and provided feedback on the work. It was scored on scientific properties (from goal to feasibility) and relevance to people with CF. We believe this feedback strengthened our research plan.
Funding Information:
Support statement: This study is funded by Corno Fonds Onderzoek Subsidie 2022 (CFOS) of the Dutch Cystic Fibrosis Foundation (R6266) to S.E.I. van der Laan, E. van der Heijden, S.L. Nijhof and C.K. van der Ent. Funding information for this article has been deposited with the Crossref Funder Registry.
Publisher Copyright:
© The authors 2023.
PY - 2023/5/1
Y1 - 2023/5/1
N2 - INTRODUCTION: For people with cystic fibrosis (CF), gaining access to elexacaftor/tezacaftor/ivacaftor (ETI) therapy, a new modulator drug combination, is perceived as a positive life event. ETI leads to a strong improvement of disease symptoms. However, some people with CF experience a deterioration in mental wellbeing after starting ETI therapy. The primary objective of this study is to investigate if and in which direction mental wellbeing of people with CF changes after starting ETI therapy. Our secondary objectives include, among others, investigation of underlying biological and psychosocial factors associated with a change in mental wellbeing of people with CF after starting ETI therapy.METHODS AND ANALYSIS: The Resilience lmpacted by Positive Stressful Events (RISE) study is a single-arm, observational, prospective longitudinal cohort. It has a timeframe of 60 weeks: 12 weeks before, 12 weeks after, 24 weeks after and 48 weeks after the start of ETI therapy. The primary outcome is mental well-being, measured at each of these four time points. Patients aged ≥12 years at the University Medical Center Utrecht qualifying for ETI therapy based on their CF mutation are eligible. Data will be analysed using a covariance pattern model with a general variance covariance matrix.ETHICS: The RISE study was classified by the institutional review board as exempt from the Medical Research Involving Human Subjects Act. Informed consent was obtained by both the children (12-16 years) and their caregivers, or only provided by the participants themselves when aged ≥16 years.
AB - INTRODUCTION: For people with cystic fibrosis (CF), gaining access to elexacaftor/tezacaftor/ivacaftor (ETI) therapy, a new modulator drug combination, is perceived as a positive life event. ETI leads to a strong improvement of disease symptoms. However, some people with CF experience a deterioration in mental wellbeing after starting ETI therapy. The primary objective of this study is to investigate if and in which direction mental wellbeing of people with CF changes after starting ETI therapy. Our secondary objectives include, among others, investigation of underlying biological and psychosocial factors associated with a change in mental wellbeing of people with CF after starting ETI therapy.METHODS AND ANALYSIS: The Resilience lmpacted by Positive Stressful Events (RISE) study is a single-arm, observational, prospective longitudinal cohort. It has a timeframe of 60 weeks: 12 weeks before, 12 weeks after, 24 weeks after and 48 weeks after the start of ETI therapy. The primary outcome is mental well-being, measured at each of these four time points. Patients aged ≥12 years at the University Medical Center Utrecht qualifying for ETI therapy based on their CF mutation are eligible. Data will be analysed using a covariance pattern model with a general variance covariance matrix.ETHICS: The RISE study was classified by the institutional review board as exempt from the Medical Research Involving Human Subjects Act. Informed consent was obtained by both the children (12-16 years) and their caregivers, or only provided by the participants themselves when aged ≥16 years.
UR - http://www.scopus.com/inward/record.url?scp=85162775828&partnerID=8YFLogxK
U2 - 10.1183/23120541.00535-2022
DO - 10.1183/23120541.00535-2022
M3 - Article
C2 - 37313395
SN - 2312-0541
VL - 9
JO - ERJ Open Research
JF - ERJ Open Research
IS - 3
M1 - 00535-2022
ER -