RISE-HP for Hypersensitivity Pneumonitis

(RISE-HP Trial)

Overseen By Anna Tharakan, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Severe depression, Severe anxiety, others

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

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special program called RISE-HP can improve the daily lives of people with hypersensitivity pneumonitis (HP). HP often leads to anxiety, depression, and significant lifestyle changes, so the program uses peer coaching and education to enhance participants' quality of life. Participants will either join the RISE-HP sessions, which include strategies like reframing negative thoughts, or a general health program called Staying Well. Individuals with HP who have a smartphone and can work with a peer coach may be well-suited for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative support strategies for enhancing daily life with HP.

Do I need to stop my current medications for the RISE-HP trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on behavioral and educational interventions, so you may not need to change your medication routine, but it's best to confirm with the trial coordinators.

What prior data suggests that this intervention is safe for improving health-related quality of life in hypersensitivity pneumonitis?

A previous study emphasized the need to improve the quality of life for people with hypersensitivity pneumonitis (HP). The RISE-HP program aims to address this need by using peer coaching and education to help patients manage their condition more effectively.

As a program focused on behavior and education, RISE-HP does not involve any drugs or medical procedures. This eliminates concerns about physical side effects or negative reactions often associated with medications. The goal is to enhance mental well-being and empower patients to feel more in control of their health.

In summary, RISE-HP is designed as a safe and supportive way to help people with HP live better lives. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RISE-HP program for hypersensitivity pneumonitis because it offers a fresh approach by focusing on improving patients' quality of life through behavioral and educational interventions. Unlike traditional treatments that might focus solely on medication to manage symptoms, RISE-HP integrates cognitive behavioral therapy to help patients reframe negative thoughts into positive actions. This peer-coach-delivered program aims to empower patients with practical tools and support, potentially leading to better long-term health outcomes.

What evidence suggests that this trial's treatments could be effective for improving quality of life in hypersensitivity pneumonitis?

Studies have shown that people with hypersensitivity pneumonitis (HP) often struggle with their quality of life due to a lack of understanding of their condition. In this trial, participants in the RISE-HP arm will receive education and support through peer coaching to enhance their quality of life. Research has shown that similar self-help programs have succeeded in other conditions, like asthma, by helping patients manage their symptoms better. Doctors agree that improving the quality of life and knowledge for HP patients is crucial. Early results suggest that RISE-HP could help patients feel more in control and improve their daily lives by teaching them effective management of their condition. ^{2 3 6 7 8}

Who Is on the Research Team?

Kerri I Aronson, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals with hypersensitivity pneumonitis, a type of lung inflammation caused by an allergic reaction to inhaled substances. Participants should be experiencing anxiety, depression, or lifestyle disruption due to HP and have a desire to improve their quality of life.

Inclusion Criteria

Have a working smart phone or tablet

English Speaking

I am willing to work with a peer coach.

Exclusion Criteria

Does not have Hypersensitivity Pneumonitis

Severe cognitive impairment as determined by their treating physician

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 10-week peer-coach delivered behavioral and educational intervention (RISE-HP) or a general health education program (Staying Well)

10 weeks

10 sessions

Follow-up

Participants are monitored for changes in anxiety, depression, fatigue, and self-efficacy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)
• Staying Well

Trial Overview The RISE-HP program is being tested against a general health education program called Staying Well. RISE-HP includes peer coaching and patient education based on cognitive behavioral principles aimed at improving the quality of life for those with HP.

How Is the Trial Designed?

Group I: Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) Experimental Treatment 1 Intervention

Participants will complete RISE-HP, 10-week peer-coach delivered, behavioral and educational intervention to improve quality of life among patients with hypersensitivity pneumonitis. This intervention will also utilize cognitive behavioral therapy, reframing negative thoughts into positive thoughts and actions.

Group II: Attention Control Experimental Treatment 1 Intervention

Participants will complete a 10-week general health education program, "Staying Well", that will discuss topics like eating healthy and cholesterol. This program will be delivered by a member of the research team.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Asthma self-management programs, particularly those like Open Airways, are crucial for minority children and have shown to be effective in reducing asthma recidivism when they include interactive and culturally relevant education.

Programs that also focus on improving literacy skills in asthmatic children can lead to significant health benefits, including a 47% decrease in asthma recidivism and very few hospitalizations over 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric asthma self-management: current concepts. Robinson, LD.[2018]

Citations

1. withpower.com withpower.com/trial/phase-pneumonia-1-2025-7f0fe

RISE-HP for Hypersensitivity Pneumonitis (RISE-HP Trial) The RISE-HP treatment is unique because it focuses on self-management and education, similar to asthma self-management programs, which emphasize patient ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39742153/

Interventions to improve quality of life and knowledge in ... Clinicians in this survey unanimously agree that interventions to improve HRQOL and knowledge are needed for people living with HP.

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.718299/full

Hypersensitivity Pneumonitis: Diagnostic and Therapeutic ... Hypersensitivity pneumonitis (HP) is one of the most common interstitial lung diseases (ILD), that presents unique challenges for a confident diagnosis and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369221006863

Diagnosis and Evaluation of Hypersensitivity Pneumonitis The purpose of this analysis is to provide evidence-based and consensus-derived guidance for clinicians to improve individual diagnostic decision-making for ...

5. journal.chestnet.org journal.chestnet.org/cms/10.1016/j.chest.2021.03.066/attachment/e1215f3c-b627-48df-8920-42145789a2e2/mmc1.pdf

Online Supplement - CHEST Journal An outbreak of hypersensitivity pneumonitis at a metalworking plant: a longitudinal assessment of intervention effectiveness. Applied occupational and ...

6. reporter.nih.gov reporter.nih.gov/project-details/10896968

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. publications.ersnet.org publications.ersnet.org/content/errev/31/163/210169

Diagnosis, course and management of hypersensitivity ... In this review, we discuss the latest guidelines for the diagnostic evaluation of patients with suspected HP, the importance of identifying patients with ...

8. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.200409-1205WS

American Journal of Respiratory and Critical Care Medicine Hypersensitivity pneumonitis (HP) develops after inhalation of many different environmental antigens, causing variable clinical symptoms ...