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Enrolling by Invitation

NCT Number: NCT06603935

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

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Sinusitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QHSLab

West Palm Beach, Florida, 33407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline, 3 months, 6 months, 12 months

    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

Secondary outcomes

  1. Change in Depression Symptoms (PHQ-9)

    Time frame: Baseline, 3 months, 6 months, 12 months

    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

  2. Change in Anxiety Symptoms (GAD-7)

    Time frame: Baseline, 3 months, 6 months, 12 months

    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

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

    Time frame: Baseline, 3 months, 6 months, 12 months

    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

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

    Time frame: 3 months, 6 months, 12 months

    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.

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

    Time frame: Baseline, 3 months, 6 months, 12 months

    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)

Sponsors and collaborators

Lead sponsor

QHSLab, Inc.

Industry

Registry information

Official study title

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

Acronym: DMAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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