Contact information
Type
Scientific
Primary contact
Dr Claire Glasscoe
ORCID ID
Contact details
Academic Child Mental Health Unit
1st Floor
Mulberry House
Alder Hey Hospital
Eaton Road
West Derby
Liverpool
L12 2AP
United Kingdom
-
glassc@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4495
Study information
Scientific title
Assessing the impact and safety of home intravenous antibiotic treatment (IVAT) for children with cystic fibrosis: a non-randomised observational study of risk within a therapeutic process
Acronym
HIVAT
Study hypothesis
1. Examine the consequences of delivering intravenous antibiotic treatment (IVAT) to children with cystic fibrosis (CF) at home
2. The clinical consequences for the child and the psychological consequences for both the carer and the child
3. The long-term aim of the project is to provide a framework to support families with this complex healthcare procedure at home
Hypotheses:
The routine burden of treatment high carer burden during the 14-day period that IVAT is delivered at home will be associated with:
1. Deficits in emotional, psychological and relational well-being for the carer and the child
2. Errors in the delivery of the IVAT
3. Reduced adherence to treatment
4. An augmentation of these effects over time rather than their habituation
Ethics approval
West Midland MREC approved on the 7th August 2008 (ref: 08/H1208/11)
Study design
Non-randomised observational validation of investigative/therapeutic process
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cystic fibrosis, respiratory disease
Intervention
1. Quantitative inquiry: A within-group prospective study of risk will compare high burden periods, indexed by the delivery of intravenous antibiotic therapy (IVAT) at home with moderate burden when routine treatments are administered
2. Longitudinal statistical modelling techniques will determine:
2.1. If high burden is related to disordered mood, reduced adherence and adverse events, 2.2. Whether negative outcomes habituate or augment over time
3. Analyses of repeated measures from individual carer/child dyad will be cast in a growth curve framework
4. Inductive inquiry: Within this quantitative framework a sub-sample of carer/child dyads will be selected for micro-level idiographic exploration of their lived experience of delivering and receiving home-based IVAT
5. The research questions will be open-ended:
5.1. What is it like for a mother to administer a course of IVAT to her child at home?
5.2. What is it like for a child to receive IVAT at home from his or her mother?
6. The quantitative and qualitative findings will be integrated for a description of the carer/child experience
7. Home IVAT: Complex healthcare treatment (intravenous antibiotic treatment) delivered by lay caregivers in the community
8. Follow up length: 12 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Adverse event score: untoward occurences during routine T1 and IVAT time T2
Secondary outcome measures
1. Adherence: during routine treatment T1 and IVAT treatment T2
2. Disordered mood (depression and anxiety) in caregivers: Routine treatment T1 and IVAT treatment T2
Overall trial start date
11/03/2009
Overall trial end date
28/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged 13 years or under
2. Confirmed diagnosis of CF for at least one year
3. Caregiver has opted to conduct the IVAT procedure him or herself at home
4. Target gender: male and female
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
UK sample size: 150
Participant exclusion criteria
1. Caregivers administering end-of-life care
2. Profound mental, physical or social problems involving statutory services
Recruitment start date
11/03/2009
Recruitment end date
28/05/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Child Mental Health Unit
Liverpool
L12 2AP
United Kingdom
Sponsor information
Organisation
Royal Liverpool Children's NHS Trust (UK)
Sponsor details
Alder Hey Children's NHS Foundation Trust
Alder Hey Hospital
Eaton Road
West Derby
Liverpool
L12 2AP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Alder Hey Children's Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0706-10381)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary