Allergy Experience Study

NCT03513965 | Completed

• 1 other identifier: 36282
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peanut Allergy

Keywords

food allergy; oral immunotherapy; mindsets; patient experience

Outcome Measures

Primary Outcomes (6)

• 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

• Occurrence of non-life-threatening symptoms

  Measured through daily REDCap surveys

  Throughout 7 months of treatment

• 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

• Treatment adherence

  Number of doses skipped or reduced because of anxiety

  Throughout 7 months of treatment

• 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

• 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

Study Arms (2)

Symptoms as Side Effects Mindset

EXPERIMENTAL

Both arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that these non-life-threatening symptoms are an unfortunate part of treatment that must be endured, similar to side effects from common medications.

Behavioral: Symptoms as Side Effects Mindset

Symptoms as Positive Signals Mindset

EXPERIMENTAL

Both arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that symptoms are a sign that that their bodies are gradually increasing desensitization, similar to having sore muscles after a difficult workout.

Behavioral: Symptoms as Positive Signals Mindset

Interventions

Symptoms as Positive Signals Mindset BEHAVIORAL

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 Positive Signals Mindset

Symptoms as Side Effects Mindset BEHAVIORAL

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.

Symptoms as Side Effects Mindset

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alia J Crum, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 2, 2018
• Study Start: January 5, 2017
• Primary Completion: August 3, 2017
• Study Completion: July 1, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08