Digital Tools for Allergic Rhinitis

(DMAR Trial)

Overseen By Marcos A Sanchez-Gonzalez, MD, PhD, MSMEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: QHSLab, Inc.

Disqualifiers: Pregnancy, Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests QHSLab Digital Tools to help manage allergic rhinitis (a condition causing sneezing, nasal congestion, and runny nose) alongside standard treatments. Participants will either receive the usual care or use the digital tools in addition to standard care to determine if these tools help control symptoms, remind them about medication, and improve their quality of life. The trial is ideal for those who have had allergic rhinitis for at least six months and find their symptoms difficult to control. Participants and healthcare providers will provide feedback on their experience with these digital tools over a year. As an unphased trial, this study offers a unique opportunity to explore innovative digital tools that could enhance quality of life.

Do I have to stop taking my current medications for the trial?

No, you do not have to stop taking your current medications. The trial requires that you continue your treatment for allergic rhinitis during the study.

What prior data suggests that these digital tools are safe for managing allergic rhinitis?

Research has shown that digital tools, such as those from QHSLab, are generally safe for people. These tools assist in managing health conditions by checking symptoms and reminding users to take their medication. In past studies, users of QHSLab's digital tools reported no major safety issues.

These tools are designed to help manage allergic rhinitis (AR), a common condition that causes sneezing and a runny nose. Studies have shown that these tools can help without causing harm. Unlike medications, digital tools do not have side effects. They function more like a coach, aiding people in adhering to their treatment plans.

Overall, evidence suggests that these digital tools are safe and easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using QHSLab digital tools for allergic rhinitis because they offer a new way to enhance symptom management and medication adherence. Unlike standard treatments like intranasal corticosteroids, antihistamines, or decongestants, these digital tools provide continuous symptom monitoring and personalized feedback based on patient-reported data. The digital platform includes features like medication reminders and tailored intervention steps, aiming to improve patients' quality of life in a more interactive and personalized manner.

What evidence suggests that these digital tools are effective for managing allergic rhinitis?

Research has shown that digital tools like QHSLab, used by participants in the experimental arm of this trial, can help manage allergic rhinitis (AR) more effectively. These tools track symptoms, remind users to take medication, and provide personalized health advice. This can lead to better symptom control and improved quality of life for those with AR. Studies also highlight the benefits of digital tools in primary care, demonstrating their effectiveness and cost-efficiency. Therefore, these tools offer a promising way to enhance treatment for individuals dealing with allergic rhinitis. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Currently receiving treatment for allergic rhinitis and willing to continue treatment during the study

Able and willing to provide informed consent electronically and comply with the study procedures

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

Exclusion Criteria

Pregnant or breastfeeding women

Individuals with severe or unstable concurrent diseases or psychological disorders that may compromise participation in the study

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard care or standard care plus digital tools for managing allergic rhinitis

12 months

Visits at baseline, 3 months, 6 months, and 12 months

Follow-up

Participants are monitored for changes in symptom severity, quality of life, and satisfaction with digital tools

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• QHSLab Digital Tools

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard Care plus Digital Tools (QHSLab with AME and ARIS) group Experimental Treatment 1 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) group Active Control 1 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.

Who Is Running the Clinical Trial?

QHSLab, Inc.

Lead Sponsor

Trials

2

Recruited

200,000+

Published Research Related to This Trial

The MASK-air® app's daily visual analog scales (VASs) for monitoring allergic rhinitis symptoms show high intra-rater reliability (ICCs between 0.870 and 0.937), indicating that users can consistently report their symptoms over time.

The VASs also demonstrate moderate to high concurrent validity when compared to established measures like the EQ-5D and CARAT scores, suggesting they are effective tools for assessing the impact of allergic rhinitis on daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity, reliability, and responsiveness of daily monitoring visual analog scales in MASK-air®. Sousa-Pinto, B., Eklund, P., Pfaar, O., et al.[2022]

A total of 72 mobile applications related to allergic rhinitis were identified, with 54 being unique, indicating a significant interest in digital tools for managing this condition.

Over half of the apps (51.4%) involved physician input in their development, suggesting a focus on credible and reliable information for users, while most apps were free and received an average rating of 3.9 out of 5.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications for Allergic Rhinitis. Zhou, AH., Patel, VR., Baredes, S., et al.[2018]

In a study involving 101 children with seasonal allergic rhinitis, adherence to daily symptom recording via a mobile app varied significantly, with 64.4% of participants being highly adherent (recording data on over 80% of days).

The study found that a higher percentage of changes in trend in symptom scores (RTSS, CSMS, and VAS) was associated with highly adherent patients, suggesting that this trend change could serve as a reliable proxy for the quality and accuracy of patient-reported data in managing allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation Parameters of Patient-Generated Data for Digitally Recorded Allergic Rhinitis Symptom and Medication Scores in the @IT.2020 Project: Exploratory Study. Dramburg, S., Perna, S., Di Fraia, M., et al.[2022]

A study using data from the MASK-air® app involving 17,780 users showed that data-driven combined symptom-medication scores (CSMSs) had moderate-to-strong correlations with established measures of rhinitis impact, indicating their effectiveness in assessing treatment outcomes.

Among the CSMSs evaluated, cluster analysis-based scores demonstrated high accuracy in distinguishing levels of rhinitis control, making them strong candidates for use as primary endpoints in future clinical trials for allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of combined symptom-medication scores for allergic rhinitis. Sousa-Pinto, B., Azevedo, LF., Jutel, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06603935

Harnessing Digital Medicine to Improve Allergic Rhinitis ... This study aims to evaluate the effectiveness of digital tools in managing allergic rhinitis (AR) in primary care settings. AR is a common condition that ...

2. qhslab.com qhslab.com/learning-lab/blog/qhslab-secures-grant-sponsorship-from-a-global-leader-in-consumer-health-to-advance-digital-medicine-tools-for-allergy-management-in-the-primary-care-setting

QHSLab Secures Grant Sponsorship from a Global Leader ... QHSLab's grant-supported study represents a major step forward in demonstrating how digital health tools can transform allergic rhinitis management in primary ...

3. ctv.veeva.com ctv.veeva.com/study/harnessing-digital-medicine-to-improve-allergic-rhinitis-management-in-primary-care-dmar

Harnessing Digital Medicine to Improve Allergic Rhinitis ... This study aims to evaluate the effectiveness of digital tools in managing allergic rhinitis (AR) in primary care settings.

4. qhslab.com qhslab.com/press-releases/qhslab-inc-publishes-peer-reviewed-studies-validating-digital-tools-for-enhancing-patient-outcomes-and-healthcare-efficiency

QHSLab, Inc. Publishes Peer-Reviewed Studies Validating ... These studies validate the clinical effectiveness and economic benefits of QHSLab's digital assessment tools in primary care settings. Key ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/?otool=iaufhhslib&term=40533611

Digital health tools in the management of allergic rhinitis Results: In all, 120 studies were included in the review, including 80 randomized controlled trials, 30 observational studies and 10 qualitative ...