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Allergic RhinitisDMARNCT06603935

Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care (DMAR)

A study testing QHSLab Digital Tools (AME and ARIS) in people with Allergic Rhinitis and Sinusitis, run by QHSLab, Inc. at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Allergic Rhinitis, Sinusitis
What is being tested?
QHSLab Digital Tools (AME and ARIS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
18 Nov 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-65 years.
  • Clinically diagnosed with allergic rhinitis and/or sinusitis for at least 6 months.
  • SNOT-22 score of ≥20, indicating uncontrolled allergic rhinitis.
  • If 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.

Who cannot join

  • Individuals under 18 or over 65 years of age.
  • Pregnant or breastfeeding women.
  • Recent surgical treatment for nasal polyps (within the last 3 months).
  • Patients with cystic fibrosis, purulent nasal infections, or any other disease likely to interfere with the study parameters.
  • Individuals with severe or unstable concurrent diseases or psychological disorders that may compromise participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • QHSLab

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: Harnessing Digital Medicine Tools for Improving Allergic Rhinitis Control in the Primary Care Setting: Optimizing Management and Outcomes Via Technology

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.

Read more

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.

Read the detailed description

This clinical trial is designed to assess the impact of integrating digital medicine tools on the management of allergic rhinitis (AR) in primary care settings. The study will compare outcomes between two groups: one receiving standard care (STC) and another receiving standard care plus digital tools from the QHSLab platform. The digital tools include the Allergy Management Evaluation (AME) and Allergic Rhinitis Intervention Steps (ARIS), both of which offer continuous monitoring, personalized feedback, and treatment optimization based on patient-reported outcomes.

The study is a prospective, randomized, controlled trial that will enroll 226 adult participants with uncontrolled allergic rhinitis, measured by the SNOT-22 score. Participants will be followed for 12 months, with data collection points at baseline, 3, 6, and 12 months. The study aims to evaluate:

Changes in symptom severity (SNOT-22 score). Medication adherence rates. Patient and provider satisfaction with the digital tools. Economic impact, including healthcare utilization and cost-effectiveness. Effects on mental health and quality of life. The study uses a mixed-methods approach, incorporating both quantitative measures and qualitative feedback through interviews with patients and healthcare providers to identify barriers and facilitators to adopting digital tools.

The QHSLab platform integrates seamlessly with current primary care workflows and includes tools for allergy management, offering insights based on patient interactions. The primary outcome is the reduction in symptom severity (SNOT-22 score), while secondary outcomes focus on patient adherence, healthcare use, satisfaction, and overall quality of life.

Being tested
QHSLab Digital Tools (AME and ARIS)
Keywords
Allergic Rhinitis, Sinusitis, Digital Medicine, QHSLab, Allergy Management Evaluation, Allergic Rhinitis Intervention Steps, Digital Health Tools, Primary Care
Medical subject headings
Rhinitis, Allergic, Sinusitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QHSLab Digital Tools (AME and ARIS)Other

    Participants will use the QHSLab digital platform, which includes two tools: the Allergy Management Evaluation (AME) and the Allergic Rhinitis Intervention Steps (ARIS). The AME provides a comprehensive digital assessment for identifying and monitoring allergic rhinitis symptoms. The ARIS offers personalized feedback based on patient-reported outcomes and continuously adjusts treatment recommendations through an algorithm. These tools support better symptom management, adherence to medication, and overall improvement in quality of life.

Study groups in NCT06603935
Study groupRoleWhat they receive
Standard Care (STC) groupNo interventionParticipants 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.
Standard Care plus Digital Tools (QHSLab with AME and ARIS) groupExperimentalParticipants 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.
Receives: Other: QHSLab Digital Tools (AME and ARIS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Allergic Rhinitis Symptom Severity (SNOT-22)

    This outcome measures the change in allergic rhinitis symptom severity using the SNOT-22 scale. Scores range from 0 to 110, with higher scores indicating worse symptoms and lower quality of life.

    unit: SNOT-22 score

    Measured: Baseline, 3 months, 6 months, 12 months

Secondary outcomes (5)

  1. Change in Depression Symptoms (PHQ-9)

    This outcome measures the change in depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) scale. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms and lower scores indicating fewer depressive symptoms and improved mental health.

    Unit: PHQ-9 score

    Measured: Baseline, 3 months, 6 months, 12 months

  2. Change in Anxiety Symptoms (GAD-7)

    This outcome measures the change in anxiety symptoms using the Generalized Anxiety Disorder-7 (GAD-7) scale. Scores range from 0 to 21, with higher scores indicating more severe anxiety and lower scores indicating fewer anxiety symptoms and improved mental health.

    Unit: GAD-7 score

    Measured: Baseline, 3 months, 6 months, 12 months

  3. Change in Quality of Life (Q-scale)

    This outcome measures the change in quality of life using the Q-scale, which assesses various aspects of a person's well-being, including relaxation, happiness, confidence, strain, pain, and satisfaction with family, work, and life. Scores range from 0 to 40, with higher scores indicating better quality of life and lower scores indicating higher risk and poorer quality of life.

    The scale is based on responses over the past 4 weeks, with items rated from \"None of the time\" to \"All of the time.\" Unit: Q-scale score

    Measured: Baseline, 3 months, 6 months, 12 months

  4. Patient Satisfaction with Digital Tools (PDTS-10)

    This 10-item scale measures patient satisfaction with the digital tools\' ease of use and perceived effectiveness. Patients rate their agreement with statements on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher scores indicate higher satisfaction with the digital tools.

    Measured: 3 months, 6 months, 12 months

  5. Provider Digital Tool Satisfaction Scale (PDTS-Provider)

    This scale measures healthcare providers\' satisfaction with the ease of use and perceived effectiveness of the digital tools in improving patient care. Providers rate their agreement with statements on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher scores indicate higher satisfaction.

    PDTS-Provider score (Range: 10 to 50, higher scores indicate greater satisfaction)

    Measured: Baseline, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start18 Nov 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study utilizes a parallel assignment model. Participants are randomized into two groups: one group receives standard care (STC) for allergic rhinitis, and the other group receives both standard care and the use of the digital medicine tools, Allergy Management Evaluation (AME) and Allergic Rhinitis Intervention Steps (ARIS), provided through the QHSLab platform. The intervention group will receive continuous digital monitoring, personalized feedback, and treatment adjustments based on patient-reported outcomes. Both groups will be followed for 12 months with assessments at baseline, 3, 6, and 12 months to evaluate symptom severity, adherence, and healthcare utilization.
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06603935
Sponsor's protocol ID
QHSLab 002-24
Acronym
DMAR
Status last verified
Feb 2026
First submitted
13 Sep 2024
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual patient data (IPD) will not be shared. The study will work with a compiled dataset that anonymizes and unifies all patient data, ensuring privacy and confidentiality

Publications

  • Rizvi, S., et al. (2022). Allergies in Primary Care: A Study of the Allergy Management Evaluation Tool. Consultant, 62, e1-e8.

Questions about this trial

What is this clinical trial studying?

A study testing QHSLab Digital Tools (AME and ARIS) in people with Allergic Rhinitis and Sinusitis, run by QHSLab, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Allergic Rhinitis Symptom Severity (SNOT-22) (time frame: Baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06603935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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