Assessing the impact and safety of Home IntraVenous Antibiotic Treatment (IVAT) for children with cystic fibrosis

ISRCTN	ISRCTN65724841
DOI	https://doi.org/10.1186/ISRCTN65724841
Secondary identifying numbers	4495

Submission date: 11/06/2010
Registration date: 28/06/2011
Last edited: 16/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Claire Glasscoe
Scientific

Academic Child Mental Health Unit
1st Floor, Mulberry House
Alder Hey Hospital
Eaton Road
West Derby
Liverpool
L12 2AP
United Kingdom

Prof Kevin Southern
Scientific

Institute in the Park
Alder Hey Children’s Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom

ORCID ID	0000-0001-6516-9083
Phone	01512933536
Email	kwsouth@liv.ac.uk

Study information

Study design	Non-randomised observational validation of investigative/therapeutic process
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	HIVAT
Study objectives	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(s)	West Midland MREC approved on the 7th August 2008 (ref: 08/H1208/11)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	11/03/2009
Completion date	28/05/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	13 Years
Sex	Both
Target number of participants	UK sample size: 150
Total final enrolment	45
Key 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
Key exclusion criteria	1. Caregivers administering end-of-life care 2. Profound mental, physical or social problems involving statutory services
Date of first enrolment	11/03/2009
Date of final enrolment	28/05/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Academic Child Mental Health Unit

Liverpool
L12 2AP
United Kingdom

Sponsor information

Royal Liverpool Children's NHS Trust (UK)
Hospital/treatment centre

Alder Hey Children's NHS Foundation Trust
Alder Hey Hospital
Eaton Road
West Derby
Liverpool
L12 2AP
England
United Kingdom

Website	http://www.alderhey.org.uk/
"ROR"	https://ror.org/00p18zw56

Funders

Funder type

Hospital/treatment centre

Alder Hey Children's Hospital (UK)

No information available

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0706-10381)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	2010 results in: https://doi.org/10.1016/S1569-1993(10)60408-0 (added 13/12/2019)
IPD sharing plan

Editorial Notes

16/12/2019: A scientific contact was added.
13/12/2019: The following changes have been made:
1. A final report link has been added to the publication and dissemination plan.
2. The final enrolment number has been added from the reference.
14/03/2017: No publications found, study status unverified.