Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
Study NCT ID:
NCT06603935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care (DMAR)
Sponsor:
QHSLab, Inc.
Organization:
Study Overview
Official Title:
Harnessing Digital Medicine Tools for Improving Allergic Rhinitis Control in the Primary Care Setting: Optimizing Management and Outcomes Via Technology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMAR
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: