Allergy Experience Study

Peanut Allergy Clinical Trial

Official title:

Changing Mindsets About Oral Immunotherapy for Peanut Allergies Via Informing Patients That Symptoms Are a Sign of Treatment Efficacy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513965
• Other study ID #: 36282
• Status: Completed
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People who are undergoing oral immunotherapy for food allergy treatment can feel anxious about the treatment process, particularly when they have allergic responses (e.g., hives, vomiting, nausea) during the dosing process. People may commonly believe that these symptoms are simply side effects that must be endured or avoided. However, the investigators propose that changing participants' mindsets about the meaning of symptoms—toward viewing them as a sign that the treatment is working and desensitization is increasing—during the treatment process will reduce anxiety and improve treatment outcomes.

Description:

Participants: The investigators will recruit participants who will receive treatment for peanut allergies through oral immunotherapy at the Sean N. Parker Center for Allergy & Asthma Research.

Procedures: The investigators will divide recruited participants into two groups (random assignment). Each group will receive different messages about oral immunotherapy, one defined as "Symptoms as Side Effects Mindset" (in which symptoms are described as an unfortunate side effect of treatment). The other group will receive messages that help foster a "Symptoms as Positive Signals Mindset" (in which symptoms are described as a sign of increasing desensitization). These messages will be conveyed verbally and through activities by the study staff and participants will also receive pamphlets emphasizing these messages.

The investigators expect that adopting a "Symptoms as Positive Signals" mindset will improve OIT outcomes in five ways:

1. Decrease anxiety about symptoms,

2. Increase treatment completion,

3. Decrease the likelihood of participants reducing dose size or skipping a dose because of anxiety about symptoms,

4. Reduce the experience of non-life-threatening symptoms during the study, and

5. Improve physiological treatment outcomes at the conclusion of the study, as measured through peanut blood IgG4 and IgE levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2018
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• peanut-specific blood IgE level >=60 Ku/L

• or, if IgE levels <60, need to have a skin prick test greater than 3mm and IgE >5 Ku/L

Exclusion Criteria:

• having previously participated in an OIT treatment or having a family member who had done so (since the study focused on educating participants about OIT)

• being in the updose phase of allergy shots or sublingual therapy

• having been intubated or admitted to an ICU because of allergic reaction

• having a heart disorder

• diagnosed eosinophilic esophagitis

• being on oral steroids or Xolair

• diagnosed anxiety disorders, as we expected this group to have higher baseline anxiety about treatment.

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Behavioral:
• Symptoms as Positive Signals Mindset
In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. However, Symptoms as Positive Signals Mindset families are additionally encouraged to think of symptoms as a positive signal that their immune system is becoming increasingly desensitized to their allergen. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.
• Symptoms as Side Effects Mindset
In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety about symptoms	Measured through daily REDCap surveys and monthly in clinic surveys; measured through parent contacting staff with concerns about symptoms	Throughout 7 months of treatment
Primary	Occurrence of non-life-threatening symptoms	Measured through daily REDCap surveys	Throughout 7 months of treatment
Primary	Treatment completion	Number of patients who complete within 2 weeks of the target end date	Up to 6 months and 2 weeks after the first clinic visit
Primary	Treatment adherence	Number of doses skipped or reduced because of anxiety	Throughout 7 months of treatment
Primary	Change in peanut blood IgG4 levels	Two blood samples assayed for IgG4 levels; one pre-treatment and one post-treatment	Change from baseline IgG4 levels after 6 months of treatment
Primary	Change in peanut blood IgE levels	Two blood samples assayed for IgE levels; one pre-treatment and one post-treatment	Change from baseline IgE levels after 6 months of treatment