Clinical trial NCT06603935: Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care (DMAR)
Official title: Harnessing Digital Medicine Tools for Improving Allergic Rhinitis Control in the Primary Care Setting: Optimizing Management and Outcomes Via Technology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Sinusitis
Keywords: Allergic Rhinitis
Sinusitis
Digital Medicine
QHSLab
Allergy Management Evaluation
Allergic Rhinitis Intervention Steps
Digital Health Tools
Primary Care
Lead sponsor: QHSLab, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Allergic Rhinitis Symptom Severity (SNOT-22)
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change in Depression Symptoms (PHQ-9)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Anxiety Symptoms (GAD-7)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Quality of Life (Q-scale)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Patient Satisfaction with Digital Tools (PDTS-10)
timeFrame: 3 months, 6 months, 12 months
measure: Provider Digital Tool Satisfaction Scale (PDTS-Provider)
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: QHSLab
state: Florida
Study officials:
References:
citation: Rizvi, S., et al. (2022). Allergies in Primary Care: A Study of the Allergy Management Evaluation Tool. Consultant, 62, e1-e8.