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Behavioural Intervention

Digital Tools for Allergic Rhinitis (DMAR Trial)

N/A

Waitlist Available

Research Sponsored by QHSLab, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 18-65 years

Clinically diagnosed with allergic rhinitis and/or sinusitis for at least 6 months

Must not have

Individuals under 18 or over 65 years of age

Recent surgical treatment for nasal polyps (within the last 3 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using digital tools, like the QHSLab platform, can help people with allergic rhinitis better manage their symptoms and treatment. Participants will be split into two groups

Who is the study for?

This trial is for individuals with allergic rhinitis, commonly known as hay fever or allergies, who may also have sinus infections. To join, participants should be seeking to manage their symptoms in a primary care setting and willing to use digital tools alongside standard care.

What is being tested?

The study tests the effectiveness of QHSLab's digital tools (AME and ARIS) in managing allergic rhinitis over 12 months. It compares standard care alone versus standard care plus these digital aids by measuring symptom control, adherence to treatment, quality of life, and healthcare usage.

What are the potential side effects?

Since this trial involves non-invasive digital tools for managing allergic rhinitis rather than medication or medical procedures, there are no direct side effects associated with traditional clinical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with allergies or sinus issues for over 6 months.

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My allergy symptoms are severe, based on a SNOT-22 score of 20 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am between 18 and 65 years old.

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I had surgery for nasal polyps in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Allergic Rhinitis Symptom Severity (SNOT-22)

Secondary study objectives

Change in Anxiety Symptoms (GAD-7)

Change in Depression Symptoms (PHQ-9)

Change in Quality of Life (Q-scale)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard Care plus Digital Tools (QHSLab with AME and ARIS) groupExperimental Treatment1 Intervention

Participants in this arm will receive the standard care for managing allergic rhinitis, which includes regular clinical evaluations and treatments as determined by their healthcare provider. In addition, they will be provided access to the QHSLab digital platform, which includes the Allergy Management Evaluation (AME) and Allergic Rhinitis Intervention Steps (ARIS) tools. These tools will offer continuous symptom monitoring, medication reminders, and personalized feedback based on patient-reported data. The intervention aims to improve symptom management, medication adherence, and quality of life over the 12-month follow-up period.

Group II: Standard Care (STC) groupActive Control1 Intervention

Participants in this arm will receive the current standard of care for managing allergic rhinitis, which includes clinical evaluations, diagnosis, and treatments based on the healthcare provider's assessment. Treatment options may include medications such as intranasal corticosteroids, antihistamines, or decongestants, as typically prescribed for allergic rhinitis management. The standard care group will not have access to the digital tools provided in the experimental arm, but their care will follow established guidelines and practices for allergic rhinitis management.

0 / 5Eligibility criteria met