Participant Information Sheet - Parent Version
Invitation
If your child is 6 - 15 years old, has a diagnosis of cystic fibrosis (CF) and is under the care of a clinical CF team we would like to invite you to complete this online survey with your child. This survey is an educational project contributing to Lauren Clayton’s PhD thesis which is a programme of scientific research that has been directly informed by people with CF and their families. Before you decide whether you want your child to be involved it is important you understand why the research is being done and what it would involve for you and your child.
Why are we doing this survey?
Traditionally it has been believed that people with CF lose an increased amount of salt through sweat, especially during exercise or when in a hot environment. Despite exercise being an important part of clinical care for people with CF, there is a lack of clear guidelines on salt supplementation or hydration when exercising with no exercise-specific guidelines. Similarly, there are no guidelines on salt supplementation or hydration available for during hot weather or exercising in hot environments.
New treatments for CF known as CFTR modulator therapies (e.g Kaftrio/Trikafta®, Symkevi/Symdeko®, Orkambi® and Kalydeco®) are now raising even more questions around salt supplementation as current guidelines only consider salt losses prior to the availability of modulator therapies. However not everyone has access to these modulator therapies, and it is important we understand more about people with and without access to these treatments.
As a group of clinicians and researchers we want to help build the research to develop clearer guidelines.
We need your help to understand your child's experiences of:
1. Physical activity and exercise behaviours
2. Experiences of symptoms of dehydration and heat-related illness
3. Current salt intake and use of salt supplements (e.g. tablets etc.) at rest, during exercise, during exposure to hot environments and whilst exercising in hot environments. As well as your current knowledge of salt supplementation and hydration guidelines or recommendations from specialists in your child's clinical CF care team.
Is my child eligible to take part?
To participate in this survey your child must meet the following criteria:
- 6 - 15 years old
- Currently under the care of a clinical CF team
- Have a clinical diagnosis of CF
What will happen to my child if they take part?
If you agree for your child to take part, you will be asked to complete the online survey alongside your child. The survey will ask questions about your child's physical activity and exercise behaviours, your child's experiences of symptoms that may be linked to dehydration or heat-related illness. You will also be asked questions on your child's current salt supplementation regime including any salt tablets they take, salt you add to their diet, or any fluid they consume to help increase their salt intake or hydration. We will ask you if your child follows any guidelines and what guidelines your child follows or whether they get any guidance from specialist in their clinical CF care team. The survey will take you approximately 20 minutes to complete.
Does my child have to be involved?
No, not at all. Being involved is completely up to you and your child. You are free to withdraw your child at any point during the survey by exiting your internet browser. Once you have submitted your child's response you can no longer withdraw your child from the study. This is because results submitted will be anonymous and we will not be able to determine which response is your child's.
Will my child's results be confidential?
Yes, all results will be kept confidential and stored anonymously. Results of the survey will be stored on the JISC software until the study closes. Once the survey has closed, data will be saved securely on the University of Portsmouth's Google Drive. Only members of the research team will have access to the data.
At the end of the study we will publicise this work in the press and in research journals. It will not be possible to identify individual responses. You will be able to access study results through a summative report which will be found on the CF Warrior's Charity website, https://www.cfwarriors.org.uk/. This will also be advertised through the CF Warrior's Charity social media accounts (Twitter; @CFwarriorsUK or Instagram; cfwarriorsorg). The data may be used to apply for further funding to continue this work.
What if there is a problem?
If you have a query, concern or complaint about any aspect of this study, in the first instance you should contact the researcher(s), if appropriate. As the researcher is a PhD student, there will also be an academic member of staff listed as the supervisor (Dr. Zoe Saynor), whom you can contact with details of the complaint. The contact details for both the researcher and Dr. Saynor are detailed at the bottom of the information sheet.
If your concern or complaint is not resolved by the researcher or their supervisor, you should contact the Head of School:
Professor Richard Thelwell
School of Sport, Health and Exercise Science
University of Portsmouth
richard.thelwell@port.ac.uk
Spinnaker Building
Cambridge Road
Portsmouth, PO1 2ER
However, if the complaint remains unresolved, please contact :
The University Complaints Officer on 023 9284 3642 or complaintsadvice@port.ac.uk
Support
If you feel you or your child needs any emotional or mental support due to any issues raised within the survey, please contact:
Samaritans: You can call free on 116 123 (24/7 helpline), email jo@samaritans.org, visit https://www.samaritans.org/
British Red Cross National Support Line: 0808 196 3651 (Monday to Friday - 10am to 5pm, Wednesday - 10am to 8pm), https://www.redcross.org.uk/get-help/support-line
For support outside of the UK, contact your nearest National Red Cross and Red Crescent Society at https://www.ifrc.org/national-societies-directory
Funding
This research is funded by the CF Warrior's Charity: https://www.cfwarriors.org.uk/.
The University of Portsmouth
School of Sport, Health and Exercise Science
Principal investigator: Lauren Clayton (lauren.clayton@port.ac.uk or 02392843085)
Chief investigator: Dr Zoe Saynor (zoe.saynor@port.ac.uk or 02392843080)