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临床试验/NCT01006382
NCT01006382已完成不适用

To What Extent do Social Cognition Models Explain Adherence to Self-care Regimens in Adolescents and Young Adults With Food Allergy

Brighton & Sussex Medical School4 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
275
试验地点
4
主要终点
Self-reported adherence to self-care regimens of adolescents and young adults with food allergy

研究概览

简要总结

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.

详细描述

Study Design: Cross-sectional comparison of the Self Regulatory Model (Leventhal, 1984) and The Health Belief Model (Rosenstock, 1966) by which the models will be used to predict and understand adherence to selfcare regimens of adolescents and young adults with food allergy.

Proposed Sample Size / Power Calculations:

The power calculation was based on multiple regression analysis for all predictor variables, 25 in total. To predict a minimum of 10% of the variance in adherence with an alpha=0.05 and power=0.90, a minimum proposed sample size of 275 participants will be needed. A 40% attrition rate has been anticipated due to the use of postal questionnaires and so a minimum of 459 participants will need to be recruited.

Analyses Nonparametric item response theory analysis, univariate correlations and multiregressional analysis for predictor models will be conducted. Structural equation modelling will also be applied to assess the goodness of fit of the two social cognition models.

Setting This study will be based in an outpatients setting and in the community. Participants will be identified and recruited from their hospital allergy clinic either whilst attending an appointment or from a hospital mail out. The third method of recruitment will involve participants from a convenience sample of the universities of Sussex and Brighton.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
13 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • If participants are unable to write or understand English

结局指标

主要结局

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

时间窗: Upon receipt of questionnaire

次要结局

未报告次要终点

研究者

发起方
Brighton & Sussex Medical School
申办方类型
Other

研究点 (4)

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