Adherence to Self-care Regimens for Young People With Food Allergy

NCT01006382 | Completed DMC

• 2 other identifiers: 09/H1102/10009/164/JON
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 4

Brief Summary

Anaphylaxis is a severe and potentially life threatening allergic reaction which can affect the airway, breathing and/or circulation. This reaction can be triggered by a number of different allergens but the most common are food, medications, insect venom and latex. Because these reactions occur suddenly and are potentially very serious, the best management lies in the correct use of the prescribed emergency medication. Epinephrine, or adrenaline as it is more commonly known, is the recommended drug for the treatment of anaphylaxis. Injecting the epinephrine into the outer thigh muscle is the preferred route of administration. For health professionals, patients and carers, this rapid administration is facilitated by the manufacture of preloaded syringes and autoinjectors. Despite the availability of these devices, a review of studies shows poor knowledge and skills amongst both health professionals and patients with regards to using autoinjectable epinephrine devices correctly. These studies found that as well as poor knowledge in using the autoinjectors, there was a lack of confidence amongst patients and an unwillingness to carry the device with them at all times. In other disease groups like asthma and diabetes, psychological models which involve asking people how they think about their illness and their related behaviours, have been found to help in the understanding of why some people follow or adhere to health professionals advice and why others do not. Based on these findings, this study will look at two appropriate psychological models and their ability to predict variation in adherence to self-care regimens in adolescents and young adults with food allergy related anaphylaxis.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• Self-reported adherence to self-care regimens of adolescents and young adults with food allergy

  Upon receipt of questionnaire

Study Arms (1)

Adolescents and young adults with food allergy

Adolescents aged 13-21 years with a diagnosis of food allergy

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hospital and community sample

You may qualify if:

• Aged between 13-21 years
• Diagnosis of food allergy
• Prescription of an epinephrine auto-injector

You may not qualify if:

• If participants are unable to write or understand English

Sponsors & Collaborators

• Brighton & Sussex Medical School: lead
• Brighton and Sussex University Hospitals NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (4)

Brighton & Sussex Medical School

Brighton, East Sussex, BN1 9PH, United Kingdom

Location

Brighton General Hospital

Brighton, East Sussex, BN2 3EW, United Kingdom

Location

Royal Alexandra Children's Hospital

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Christina J Jones, BA MSc

  Brighton & Sussex Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2009-10

Locations

GB (4)