ISRCTN ISRCTN12504076
DOI https://doi.org/10.1186/ISRCTN12504076
Secondary identifying numbers 9932
Submission date
07/03/2011
Registration date
07/03/2011
Last edited
24/02/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Thisanayagam Umasunthar
Scientific

Department of Paediatrics
Wright-Fleming Institute
Norfolk Place
London
W2 1PG
United Kingdom

Email t.umasunthar@imperial.ac.uk

Study information

Study designRandomised interventional process of care
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the conatct details below to request a patient information sheet
Scientific titleMeasures to Address Maternal Anxiety: a randomised control study
Study acronymMAMA
Study objectivesThis is a factorial randomised controlled trial of two different interventions in the same population, to answer two different questions. The first intervention compares two adrenaline auto-injector devices, namely Anapen® and EpiPen®, to evaluate whether one is easier than the other for parents of a food allergic child to learn to use effectively. The second intervention compares two different methods for discussing risks associated with food allergy with mothers of food allergic children, to evaluate their effect on maternal anxiety. 200 mothers with children who have food allergy will be randomised to one of four groups in a 2x2 factorial study design. The primary outcome measure for the comparison of adrenaline auto-injectors is effective delivery of adrenaline in a simulated scenario 6 weeks after training, using a trainer auto-injector device. The primary outcome measure for the informational intervention is maternal state anxiety score 6 weeks after the intervention.
Ethics approval(s)West London Research Ethics Committee 2, ref: REC10/H0711/76
Health condition(s) or problem(s) studiedTopic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
InterventionAdrenaline auto-injector: participants will be randomised to receive training with either Anapen® or EpiPen®.
Informational intervention: participants will be randomised to receive either a new approach to discussing food allergy or current standard of care.

Study Entry: Single Randomisation only
Intervention typeOther
Primary outcome measureState anxiety (STAI) score; Timepoint(s): 6 weeks (primary outcome) and 12 months (secondary outcome)
Secondary outcome measuresSuccessful administration of adrenaline using a trainer device, judged by an independent observer; Timepoint(s): 6 weeks (primary) and 12 months (secondary)
Overall study start date28/02/2011
Completion date02/03/2012

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 200; UK Sample Size: 200
Key inclusion criteriaPilot phase:
Parents of children attending the paediatric outpatient department at St Mary's Hospital – food allergic/atopic/healthy groups categorised according to diagnoses made by the treating clinician. Food allergic group will be limited to those with IgE-mediated food allergy.

Main study:
1. Children aged 0-18 with food allergy (and their mother) diagnosed at a tertiary paediatric allergy clinic and need for adrenaline auto-injector prescription due to risk of anaphylaxis
2. Patient weight = 7.5 kg
3. Ability to converse fluently and read instructions in English or with an appropriate translator
Key exclusion criteriaPilot phase:
Parents of children with known non-atopic chronic diseases likely to impact on maternal anxiety and stress will be excluded from this pilot phase

Main study:
1. Previous training to use an injectable adrenaline device
2. Known psychiatric morbidity such as psychotic disorders which might be expected to impact on the validity and appropriateness of the psychological intervention
3. Poor English language fluency and/or poor reading ability
Date of first enrolment28/02/2011
Date of final enrolment02/03/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Wright-Fleming Institute
London
W2 1PG
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom

ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Industry

Lincoln Medical (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2015 Yes No

Editorial Notes

24/02/2016: Publication reference added.