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Allergy Experience Study

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Symptoms as Positive Signals Mindset
Symptoms as Side Effects Mindset
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peanut Allergy focused on measuring food allergy, oral immunotherapy, mindsets, patient experience

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Symptoms as Side Effects Mindset

    Symptoms as Positive Signals Mindset

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Anxiety about symptoms
    Measured through daily REDCap surveys and monthly in clinic surveys; measured through parent contacting staff with concerns about symptoms
    Occurrence of non-life-threatening symptoms
    Measured through daily REDCap surveys
    Treatment completion
    Number of patients who complete within 2 weeks of the target end date
    Treatment adherence
    Number of doses skipped or reduced because of anxiety
    Change in peanut blood IgG4 levels
    Two blood samples assayed for IgG4 levels; one pre-treatment and one post-treatment
    Change in peanut blood IgE levels
    Two blood samples assayed for IgE levels; one pre-treatment and one post-treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    April 12, 2018
    Last Updated
    August 6, 2018
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03513965
    Brief Title
    Allergy Experience Study
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 5, 2017 (Actual)
    Primary Completion Date
    August 3, 2017 (Actual)
    Study Completion Date
    July 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed 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: Decrease anxiety about symptoms, Increase treatment completion, Decrease the likelihood of participants reducing dose size or skipping a dose because of anxiety about symptoms, Reduce the experience of non-life-threatening symptoms during the study, and Improve physiological treatment outcomes at the conclusion of the study, as measured through peanut blood IgG4 and IgE levels.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peanut Allergy
    Keywords
    food allergy, oral immunotherapy, mindsets, patient experience

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Symptoms as Side Effects Mindset
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Symptoms as Positive Signals Mindset
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Symptoms as Positive Signals Mindset
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Symptoms as Side Effects Mindset
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Anxiety about symptoms
    Description
    Measured through daily REDCap surveys and monthly in clinic surveys; measured through parent contacting staff with concerns about symptoms
    Time Frame
    Throughout 7 months of treatment
    Title
    Occurrence of non-life-threatening symptoms
    Description
    Measured through daily REDCap surveys
    Time Frame
    Throughout 7 months of treatment
    Title
    Treatment completion
    Description
    Number of patients who complete within 2 weeks of the target end date
    Time Frame
    Up to 6 months and 2 weeks after the first clinic visit
    Title
    Treatment adherence
    Description
    Number of doses skipped or reduced because of anxiety
    Time Frame
    Throughout 7 months of treatment
    Title
    Change in peanut blood IgG4 levels
    Description
    Two blood samples assayed for IgG4 levels; one pre-treatment and one post-treatment
    Time Frame
    Change from baseline IgG4 levels after 6 months of treatment
    Title
    Change in peanut blood IgE levels
    Description
    Two blood samples assayed for IgE levels; one pre-treatment and one post-treatment
    Time Frame
    Change from baseline IgE levels after 6 months of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alia J Crum, PhD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    If made publicly available, all data will be de-identified and the anonymous data will be shared with researchers on the Open Science Framework

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    Allergy Experience Study

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