Real-Time Care Outreach for Asthma

(RIDUNA Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must be taking: Inhaled corticosteroids

Must not be taking: Omalizumab

Disqualifiers: COPD, Emphysema, Cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether real-time notifications to patients and doctors about uncontrolled asthma can improve asthma management. It focuses on individuals who regularly use inhaled corticosteroids (medications that reduce airway inflammation) but still struggle with asthma control. The goal is to determine if real-time alerts lead to better asthma management compared to usual care. Participants must have had asthma for at least a year and frequently require extra medication or doctor visits due to flare-ups. As an unphased trial, this study offers a unique opportunity to contribute to innovative asthma management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it seems to focus on patients already using inhaled corticosteroids for asthma, so you might continue with those.

What prior data suggests that this real-time asthma care outreach is safe?

A previous study demonstrated positive results for a real-time asthma outreach program in managing asthma. Patients in the program required fewer extra doses of emergency medication than those not in the program. This suggests the program enhances asthma management through real-time monitoring and timely advice.

Additionally, digital tools that track medication use aid patients in adhering to their treatment plans. More than half of the users continued using these tools after six months, indicating practicality and acceptance.

Overall, these findings indicate that real-time asthma care outreach is well-received and can improve asthma control without significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the real-time asthma care outreach because it offers a new way to manage asthma, focusing on timely communication and intervention. Unlike standard treatments that primarily rely on patient-initiated use of inhaled corticosteroids, this approach provides proactive support, potentially improving adherence and outcomes. By leveraging real-time data and outreach, it aims to personalize care and prevent asthma attacks before they occur, offering a more responsive and preventive strategy compared to traditional methods.

What evidence suggests that real-time asthma care outreach is effective for improving asthma control?

Research shows that tracking asthma in real time can improve management. In this trial, participants in the "Real-time asthma care outreach" arm will use this method, which studies have shown reduces the need for quick-relief medicine (50.7% compared to 57.1% for those not using this method). One study found that digital tools for monitoring asthma help doctors adjust treatment plans quickly and accurately, leading to better management. Programs using real-time monitoring have also resulted in better health outcomes and fewer emergency visits for asthma-related issues. This suggests that real-time tracking can lead to better overall control for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert S Zeiger, MD, PhD

Principal Investigator

Kaiser Permanente Southern California Region

Are You a Good Fit for This Trial?

The RIDUNA trial is for people aged 12-56 with asthma who've been on inhaled corticosteroids and have uncontrolled symptoms. They should have used a quick-relief inhaler frequently or had repeated need for oral steroids due to severe flare-ups, indicating poor asthma control.

Inclusion Criteria

My asthma has been uncontrolled in the past year.

I have used an inhaled corticosteroid in the last 6 months.

I have either used 7 asthma relief inhalers recently or had 2 steroid treatments for asthma attacks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Real-time asthma care outreach

Real-time identification and notification of uncontrolled asthma status to patients and specialists, with guideline-directed intervention

12 months

Follow-up

Participants are monitored for asthma control improvements, including impairment and risk reduction

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Inhaled Corticosteroids
• Real-time asthma care outreach

Trial Overview This study tests if notifying both patients and specialists in real-time about uncontrolled asthma events leads to better management compared to usual care. It's based on following national guidelines right after identifying these events through electronic records.

How Is the Trial Designed?

Group I: Real-time asthma care outreach Experimental Treatment 1 Intervention

Group II: Usual care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25017534/

Real-time asthma outreach reduces excessive short-acting ... Conclusions: A novel administrative-based asthma outreach program improves markers of asthma impairment in patients without prior asthma specialist care and is ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219814000683

Real-Time Asthma Outreach Reduces Excessive Short ... Results. Compared with controls, intervention patients reached 7 SABA canister dispensings less frequently (50.7% vs 57.1%; risk ratio 0.89 [95% CI, 0.82 ...

3. frontiersin.org frontiersin.org/journals/allergy/articles/10.3389/falgy.2024.1451768/full

Asthma management in the digital age Digital inhaler systems can collect real-time data on medication usage, facilitating immediate adjustments to treatment plans based on precise adherence ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9581584/

Improving Asthma Care Documentation with a Digital Tool ... Real-time asthma outreach reduces excessive short-acting ... Enabling asthma management and outcomes monitoring through standardized EMR data and eTools.

5. cdc.gov cdc.gov/national-asthma-control-program/media/pdfs/2024/05/Moving_the_Needle_Asthma_Control-508.pdf

Moving the Needle on Asthma Control Wisconsin developed and distributed a document showcasing that their asthma home-visiting program improved health outcomes, decreased asthma-related emergency ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12400179/

Enhancing severe asthma care: real-world outcomes of a ... Our data indicate that the use of the Propeller digital platform supports adherence (68% of patients who continued to use the platform at 6 months were adherent) ...

7. aws.amazon.com aws.amazon.com/blogs/infrastructure-and-automation/real-time-patient-monitoring-architecture-on-aws-for-smart-inhalers/

Real-time patient monitoring architecture on AWS for smart ... Healthcare teams can use this end-to-end solution to monitor patient populations in near real time, predict asthma exacerbations, and develop ...