- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06623799
Impact of Help-Seeking Behaviors on Allergic Rhinitis and Mental Health: A Longitudinal Study
Impact of Help-Seeking Behaviors on Allergic Rhinitis, Asthma Control, and Mental Health: A Retrospective and Longitudinal Analysis of Allergy Medication Use
Study Overview
Status
Conditions
Detailed Description
This study aims to investigate the impact of help-seeking behaviors (HSB) on allergic rhinitis (AR), asthma control, and mental health outcomes, such as anxiety and depression, using both retrospective and longitudinal data. The study examines patients who have been diagnosed with AR and mental health conditions to assess how seeking professional help for allergies, emotional well-being, or both influences symptom control and quality of life.
The research analyzes data from a diverse patient population to evaluate the effects of AR medications (intranasal steroids, antihistamines, decongestants, and leukotriene blockers) on both AR and mental health symptoms. Additionally, it explores the role of help-seeking behaviors in improving symptom management, specifically through the use of validated tools like the SNOT-22 for AR and the PHQ-GAD16 for mental health.
The study emphasizes the importance of integrating mental health screening and support into the treatment of allergic rhinitis and asthma. By analyzing real-world data, the research seeks to provide insights into how coordinated care approaches can enhance patient outcomes and inform future clinical practices.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marcos A Sanchez-Gonzalez, MD, PhD
- Phone Number: 850-559-7676
- Email: masanchez@qhslab.com
Study Contact Backup
- Name: Troy Grogan
- Email: troy.grogan@usaqcorp.com
Study Locations
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Florida
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West Palm Beach, Florida, United States, 33407
- Recruiting
- QHSLab
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Contact:
- Marcos A Sanchez-Gonzalez, MD, PhD
- Phone Number: 8505597676
- Email: masanchez@qhslab.com
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Contact:
- Troy Grogan
- Phone Number: (929) 379-6503
- Email: troy.grogan@usaqcorp.com
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Principal Investigator:
- Marcos A Sanchez-Gonzalez, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Allergic Rhinitis Symptom Severity (SNOT-22 Score)
Time Frame: baseline and yearly follow-up for up to 5 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depression Symptoms (PHQ-9 Score)
Time Frame: Baseline and yearly follow-up for up to 5 years
|
This outcome measures the change in depressive symptoms using the Patient Health Questionnaire (PHQ-9).
The PHQ-9 is a validated tool to assess the severity of depression.
Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
The study will assess how help-seeking behaviors for both allergies and mental health impact the severity of depressive symptoms over time.
|
Baseline and yearly follow-up for up to 5 years
|
|
Change in Anxiety Symptoms (GAD-7 Score)
Time Frame: Baseline and yearly follow-up for up to 5 years
|
This outcome measures the change in anxiety symptoms using the Generalized Anxiety Disorder Scale (GAD-7).
The GAD-7 is a validated tool to assess the severity of anxiety.
Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
The study will assess how help-seeking behaviors for both allergies and mental health impact the severity of anxiety symptoms over time.
|
Baseline and yearly follow-up for up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of Help-Seeking Behaviors on Symptom Control and Quality of Life
Time Frame: Baseline and yearly follow-up for up to 5 years
|
This outcome evaluates the effect of help-seeking behaviors (seeking help for emotional well-being, allergies, or both) on overall symptom control and quality of life.
The study will explore the relationship between help-seeking behaviors and improvements in allergic rhinitis symptoms (SNOT-22) and mental health outcomes (PHQ-9, GAD-7).
Scores from each scale will be analyzed separately to assess the impact of help-seeking behaviors on these specific health outcomes.
|
Baseline and yearly follow-up for up to 5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QHSLab 001-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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