Inherited Cardiac Conditions Clinical Trial
Official title:
How do Families Experience Receiving a Positive Diagnosis for an Inherited Cardiac Condition for a Child? The Experiences of Children With a Diagnosis, Their Parents and Siblings.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05158738 -
Inherited Cardiac cONditions In Kids
|
||
| Recruiting |
NCT04312230 -
The Role of Biomarkers in Inherited Cardiac Conditions
|