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

240 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment QHSLab Digital Tools for allergic rhinitis?

Digital tools like MASK-rhinitis have shown promise in managing allergic rhinitis by helping patients track symptoms and medication use, which can improve disease control and quality of life. These tools empower patients and support healthcare providers in making informed treatment decisions. ^{1 2 3 4 5}

Is there any safety data available for QHSLab Digital Tools or similar digital tools used in allergic rhinitis?

The research does not provide specific safety data for QHSLab Digital Tools or similar digital tools used in allergic rhinitis. However, these tools are designed to monitor symptoms and medication use, which suggests they are generally safe as they focus on data collection rather than direct medical intervention. ^{1 5 6 7 8}

How is the QHSLab Digital Tools treatment for allergic rhinitis different from other treatments?

QHSLab Digital Tools for allergic rhinitis is unique because it uses digital technology, like apps, to help manage symptoms and improve patient care. This approach focuses on patient-reported outcomes and integrates with healthcare systems to provide personalized treatment pathways, unlike traditional medication-based treatments. ^{1 2 4 9 10}

What is the purpose of this trial?

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 affects many people's quality of life. The study will test whether digital tools, such as the QHSLab platform, can help patients better control their symptoms, improve adherence to treatment, and enhance overall well-being. The trial will compare two groups: one using standard care and the other using both standard care and digital tools. Participants will be monitored over 12 months, and the study will measure changes in symptom severity, treatment adherence, quality of life, and healthcare usage. The study will also gather feedback from patients and healthcare providers about their experience with the digital tools. The digital tools used in this study are designed to help patients manage their AR more effectively by providing regular symptom assessments, medication reminders, and personalized feedback based on their health data. This summary ensures the information is clear and straightforward for patients, families, and healthcare providers while maintaining compliance with IRB guidelines.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Patient-centered digital biomarkers for allergic respiratory diseases and asthma: The ARIA-EAACI approach - ARIA-EAACI Task Force Report. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Mobile Technology in Allergic Rhinitis: Evolution in Management or Revolution in Health and Care? [2020]

3. England pubmed.ncbi.nlm.nih.gov

Rhinitis management: the patient's perspective. [2019]

4. England pubmed.ncbi.nlm.nih.gov

MASK-rhinitis, a single tool for integrated care pathways in allergic rhinitis. [2015]

5. Denmark pubmed.ncbi.nlm.nih.gov

MACVIA-ARIA Sentinel NetworK for allergic rhinitis (MASK-rhinitis): the new generation guideline implementation. [2022]

6. Canada 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. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

Development and validation of combined symptom-medication scores for allergic rhinitis. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Real-life evidence in allergen immunotherapy: Moving forward with mHealth apps. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Validity, reliability, and responsiveness of daily monitoring visual analog scales in MASK-air®. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Mobile Applications for Allergic Rhinitis. [2018]