NCT06623799

Brief Summary

This study explores how help-seeking behaviors for both emotional well-being and allergies impact the management of allergic rhinitis, asthma, and mental health symptoms, including anxiety and depression. The research involves a retrospective and longitudinal analysis of patients who sought treatment for allergic rhinitis and mental health concerns. The goal is to highlight the importance of integrating mental health care into allergy treatment plans to improve overall patient outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jan 2020Jan 2027

Study Start

First participant enrolled

January 1, 2020

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2027

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

7.1 years

First QC Date

September 13, 2024

Last Update Submit

February 9, 2026

Conditions

Mental Health ConditionsAllergic

Keywords

Allergic RhinitisAsthma ControlMental HealthHelp-Seeking BehaviorsIntegrated Care

Outcome Measures

Primary Outcomes (1)

  • Change in Allergic Rhinitis Symptom Severity (SNOT-22 Score)

    This outcome measures the long-term change in allergic rhinitis symptom severity over several years using the Sinonasal Outcome Test (SNOT-22). The SNOT-22 is a validated tool that assesses the impact of sinonasal conditions on quality of life. The study will track the effects of help-seeking behaviors for both allergies and mental health (anxiety and depression) on allergic rhinitis symptom control, examining changes in SNOT-22 scores over multiple follow-up periods. Scores range from 0 to 110, with higher scores indicating worse symptoms and lower quality of life.

    baseline and yearly follow-up for up to 5 years

Secondary Outcomes (2)

  • Change in Depression Symptoms (PHQ-9 Score)

    Baseline and yearly follow-up for up to 5 years

  • Change in Anxiety Symptoms (GAD-7 Score)

    Baseline and yearly follow-up for up to 5 years

Other Outcomes (1)

  • Effect of Help-Seeking Behaviors on Symptom Control and Quality of Life

    Baseline and yearly follow-up for up to 5 years

Eligibility Criteria

Age4 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This repository collects data from primary care patients diagnosed with allergic rhinitis, asthma, anxiety, or depression. The repository aims to track health outcomes, medication usage, and help-seeking behaviors to support future research on the interaction between chronic physical and mental health conditions. The population includes adult patients who consent to the inclusion of their data and who seek care in a primary care setting for the specified conditions.

You may qualify if:

  • Adults (aged 18 years or older) Patients actively receiving care in a primary care setting. Patients who have provided informed consent for their health data to be included in the research repository.

You may not qualify if:

  • Patients who have not provided informed consent for their health data to be included in the research repository.
  • Patients diagnosed with chronic conditions outside the scope of allergic rhinitis, asthma, or mental health conditions (anxiety, depression).
  • Patients with severe mental health disorders or comorbidities that are unrelated to the conditions of interest (e.g., schizophrenia, bipolar disorder, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QHSLab

West Palm Beach, Florida, 33407, United States

RECRUITING

MeSH Terms

Conditions

Rhinitis, AllergicPsychological Well-BeingHelp-Seeking Behavior

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPersonal SatisfactionBehaviorSocial Behavior

Central Study Contacts

Marcos A Sanchez-Gonzalez, MD, PhD

CONTACT

850-559-7676masanchez@qhslab.com

Troy Grogan

CONTACT

troy.grogan@usaqcorp.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2024

First Posted

October 2, 2024

Study Start

January 1, 2020

Primary Completion (Estimated)

January 25, 2027

Study Completion (Estimated)

January 25, 2027

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy concerns and the need to protect patient confidentiality. Data collected in this study is used for internal analysis, and only aggregated, anonymized data will be made available for research purposes. This ensures compliance with privacy regulations such as HIPAA and protects patient identities.

Locations

US(1)