NCT01054950

Brief Summary

Food allergies are becoming more prevalent with more children being diagnosed with food allergies each year. Food allergies place a tremendous burden not just on the patient but on his/her family as well. In an attempt to provide better care to the investigators patients, the investigators would like to determine if regular contact with our food allergy nurse has a positive effect on a family's perceived quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

January 21, 2010

Last Update Submit

June 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in validated quality of life survey

    twelve months

Study Arms (2)

Education and counseling

EXPERIMENTAL

Phone calls using behavioral techniques

Behavioral: Counseling

Control

PLACEBO COMPARATOR

Single phone call

Behavioral: Placebo phone call

Interventions

CounselingBEHAVIORAL

Our food allergy nurse will contact our intervention group and discuss any questions or concerns they may have regarding their child's food allergy.

Education and counseling

Phone call w/ no behavioral counseling

Control

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • IgE mediated food allergy
  • Ages 0-17
  • Willing to participate

You may not qualify if:

  • Food sensitivities
  • Unable to understand or read survey
  • Unable to be available for follow up survey and nurse phone calls.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Allergy and Immunology Clinic

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

  • Baptist AP, Dever SI, Greenhawt MJ, Polmear-Swendris N, McMorris MS, Clark NM. A self-regulation intervention can improve quality of life for families with food allergy. J Allergy Clin Immunol. 2012 Jul;130(1):263-5.e6. doi: 10.1016/j.jaci.2012.03.029. Epub 2012 Apr 26. No abstract available.

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Alan Baptist, M.D

    University of Michigan Allergy and Immunology Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

June 30, 2016

Record last verified: 2016-06

Locations