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

This study has been completed.
Sponsor:
Collaborators:
Brighton and Sussex University Hospitals NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Information provided by:
Brighton & Sussex Medical School
ClinicalTrials.gov Identifier:
NCT01006382
First received: October 30, 2009
Last updated: June 21, 2011
Last verified: October 2009
  Purpose

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.


Condition
Food Allergy

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: To What Extent do Social Cognition Models Explain Adherence to Self-care Regimens in Adolescents and Young Adults With Food Allergy

Resource links provided by NLM:


Further study details as provided by Brighton & Sussex Medical School:

Primary Outcome Measures:
  • Self-reported adherence to self-care regimens of adolescents and young adults with food allergy [ Time Frame: Upon receipt of questionnaire ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adolescents and young adults with food allergy
Adolescents aged 13-21 years with a diagnosis of food allergy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital and community sample

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • If participants are unable to write or understand English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006382

Locations
United Kingdom
Royal Alexandra Children's Hospital
Brighton, East Sussex, United Kingdom, BN2 5BE
Brighton General Hospital
Brighton, East Sussex, United Kingdom, BN2 3EW
Brighton & Sussex Medical School
Brighton, East Sussex, United Kingdom, BN1 9PH
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Brighton & Sussex Medical School
Brighton and Sussex University Hospitals NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Christina J Jones, BA MSc Brighton & Sussex Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: Miss Christina Jones, Brighton & Sussex Medical School
ClinicalTrials.gov Identifier: NCT01006382     History of Changes
Other Study ID Numbers: 09/H1102/100, 09/164/JON
Study First Received: October 30, 2009
Last Updated: June 21, 2011
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 28, 2014