Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603935
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care DMAR
Sponsor:
None
Organization:
None
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:
No
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 peoples 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None