Families' Experiences of Paediatric ICC Diagnosis

NCT02737111 | Unknown

• 1 other identifier: 2015PC002B
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Inherited Cardiac Conditions

Outcome Measures

Primary Outcomes (1)

• Experience of recieving a diagnosis of an ICC.

  Semi-structured interviews (Child, Sibling and Parent version) will be transcriped and analysed using thematic analysis, whereby common themes will be identified within and between participant interviews. Thematic analysis is a method for identifying, analysing and reporting patterns (themes) within data. Thematic analysis is a way to organise and describe a data set from qualitative interviews in rich detail.

  Interviews will occur within 2-3 months of recieiving the diagnosis

Interventions

Initial Screening Process BEHAVIORAL

The doctor who meets with the family to share the diagnosis will give the participants a flyer about the research study at the end of their consultation and will briefly explain the study aim and purpose. Following this, the ICC Service Clinical Nurse Specialists (CNS) and the primary researcher will identify patients who meet the inclusion and exclusion criteria and all patients who are eligible to take part will be contact by a CNS shortly after a child receives a diagnosis to follow up with the family, and ask permission for the primary researcher to contact the child's parents to discuss the study.

Information and Informed Consent BEHAVIORAL

The researcher will contact parents of patients who agreed some weeks after receiving the diagnosis, check inclusion criteria, and information sheets will be provided. Individuals who consent to participate will arrange to meet with the researcher in their family home or at the hospital. When they meet, the researcher will go through the participant information sheet with the individuals, and gain written consent for participation

Interview BEHAVIORAL

Families who wish to take part will be invited to participate in an interview 2-3 months after they received the diagnosis from the hospital. At least ten families (and therefore at least 30 individuals including children with the diagnosis, parents and siblings) will be interviewed separately, about their experiences of the communication about the diagnosis to them, their child or their siblings. Younger children may do some drawings with the researcher about their experiences, and the researcher will ask questions about these drawings.Participants can be included even if not all family members wish to take part.

Validated Questionnaires BEHAVIORAL

Each member of the family will complete the mood and quality of life questionnaires.

Debrief BEHAVIORAL

At the end of each interview the research will explore with the individual to discuss how they found the experience and answer any questions they might have and review the questionnaires that they completed. The researcher will then meet with children and parents together to discuss the experience as a family.Information will be shared with families about options for accessing support including the paediatric psychology service at the hospital or local support services, if they wish. After the interviews, the researcher will send a letter to participants GP and medical team to inform them that they are taking part.

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Siblings of children who have received a diagnosis of an inherited cardiac condition who are between the ages of 8 and 16 years.
• Children will only participate if they are already aware of their diagnosis or their sibling's diagnosis.
• Children will only participate if they and a parent/person with parental responsibility have both consented to take part.
• Parents will only take part if they have given informed consent

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Ben Williams Trust: collaborator

MeSH Terms

Interventions

Informed Consent; Interviews as Topic

Intervention Hierarchy (Ancestors)

Patient Rights; Human Rights; Social Control, Formal; Health Care Economics and Organizations; Jurisprudence; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jan Till, Doctor

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantell Douglas, Doctor

CONTACT

C.Douglas@rbht.nhs.uk

Michele Puckey

CONTACT

M.Puckey@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 13, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share