Families' Experiences of Paediatric ICC Diagnosis

This study aims to further understand the experiences of children, their parents and siblings around the time when the child and their family are informed of a diagnosis of an inherited cardiac condition (ICC). The researchers are interested to understand how families experience the process of receiving a diagnosis of an ICC, and explore experiences from multiple perspectives within the family (i.e. parents, children and siblings).

The Primary Project Objective:

How do children, their parents and siblings experience the communication of a diagnosis of an inherited cardiac condition (ICC)? What is found to be helpful and less helpful?

The Secondary Project Objective:

To explore qualitatively how families experience the communication of a positive diagnosis for an inherited cardiac condition for a child and will seek the perspectives of the child with the diagnosis, their siblings and parents.

Background Information and Study Rationale:

An ICC comprise of a number of conditions that affect either the heart muscle (cardiomyopathies), or the electrical circuits of the heart (ion channelopathies). ICCs can result in the heart working ineffectively, dangerous arrhythmias and sudden death. The last decade has seen dramatic advances in understanding of the pathology of ICCs. More than 50 ICCs have been recognised and genetics tests are increasingly available. Epidemiological evidence suggests a combined total prevalence for ICCs of about 340,000 in the UK.

In response to advances in medical and genetic understanding of ICCs, ICC services have also grown dramatically, accompanied by commissiioning guidelines, and when an ICC is diagnosed there are implications not only for the patient themselves but for relatives. For families affected by inherited cardiac conditions, the layers of impact can be complex. When a child receives a positive diagnosis there can be implications for parents and siblings not only of living with the child's diagnosis, but also for one's own health and wellbeing. This can lead to uncertainty about the health of others in the family and subsequent medical investigates.

To the researchers' knowledge, there is little published evidence which aims to understand the experiences of children and their siblings of the communication around their ICC condition. Therefore ICC services risk of relying on our own clinical intuition or the views of parents rather than hearing directly from children and young people themselves. This present study therefore proposed to explore qualitatively how families experience the communication of a positive diagnosis for an inherited cardiac condition for a child and will seek the perspectives of the child with the diagnosis, their siblings and parents.

Participants will be recruited from a ICC service at an NHS Hospital in London. Paedaitric patients (who have been given an ICC diagnosis) and their siblings will be aged 8-16, and their Parents. Patient recruitment at a site will only commence once the trial team has ensured that the following approval/essential documents are in place:

1. The main REC approval,
2. Final sponsorship and/or R\&D approval (NHS Permission),
3. Local Site Delegation of Duties and Signature Log is completed.

All subjects who wish to enter the study will be fully screened and consented by the Chief Investigator (CI), or one of the qualified clinicians involved in the study as the Researchers.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 8 - 16 who have received a positive diagnosis of an inherited cardiac condition from the ICC service at the hospital within the last 3 months, their parents and siblings.
2. Siblings of children who have received a diagnosis of an inherited cardiac condition who are between the ages of 8 and 16 years.
3. Children will only participate if they are already aware of their diagnosis or their sibling's diagnosis.
4. Children will only participate if they and a parent/person with parental responsibility have both consented to take part.
5. Parents will only take part if they have given informed consent

Exclusion Criteria:

1. Children who are unable to communicate verbally will not be included in the research as they would be unable to consent to their involvement in the research and alternative means of data collection would be required.

Discontinuation/ withdrawal of Pariticpants and Stopping Rules:

Participants can withdraw their participation from the study at any time without giving a reason and if this happens, the data collected from their interviews/questionnaires will not be used in the study results. Adult participants will be told that they can tell the researcher if they would like to withdraw. The researcher will agree a word or sign with child participants to indicate that they would like to stop taking part and the researcher will then ask them whether they would like the data used to be included in the results of the study.

The researcher will continue to recruit participants until there is sufficient data for qualitative analysis of interviews.

It is unlikely that the study will be stopped prematurely but this might occur if insufficient numbers of participants are able to be recruited from one or more of the patient samples (i.e. children with a diagnosis, parents or siblings) in the designated time frame.