Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/06/2010
Date assigned
28/06/2011
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.alderhey.org.uk/

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

Publication citations

Additional files

Editorial Notes