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

NCT06603935 | Enrolling By Invitation

• 1 other identifier: QHSLab 002-24
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergic Rhinitis; Sinusitis

Keywords

Allergic Rhinitis; Sinusitis; Digital Medicine; QHSLab; Allergy Management Evaluation; Allergic Rhinitis Intervention Steps; Digital Health Tools; Primary Care

Outcome Measures

Primary Outcomes (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

  Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (5)

• Change in Depression Symptoms (PHQ-9)

  Baseline, 3 months, 6 months, 12 months

• Change in Anxiety Symptoms (GAD-7)

  Baseline, 3 months, 6 months, 12 months

• Change in Quality of Life (Q-scale)

  Baseline, 3 months, 6 months, 12 months

• Patient Satisfaction with Digital Tools (PDTS-10)

  3 months, 6 months, 12 months

• Provider Digital Tool Satisfaction Scale (PDTS-Provider)

  Baseline, 3 months, 6 months, 12 months

Study Arms (2)

Standard Care (STC) group

NO 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.

Standard Care plus Digital Tools (QHSLab with AME and ARIS) group

EXPERIMENTAL

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.

Other: QHSLab Digital Tools (AME and ARIS)

Interventions

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.

Standard Care plus Digital Tools (QHSLab with AME and ARIS) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QHSLab, Inc.: lead

Study Sites (1)

QHSLab

West Palm Beach, Florida, 33407, United States

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic; Sinusitis

Interventions

methylamphotericin B

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: November 18, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)