RISE-HP for Hypersensitivity Pneumonitis

(RISE-HP Trial)

Overseen By Alicia Morris

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

Trial Summary

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 data supports the effectiveness of the RISE-HP treatment for Hypersensitivity Pneumonitis?

The study on sarcoidosis shows that a comprehensive home monitoring program, which includes patient education and self-management, was well-received and feasible, suggesting that similar approaches in RISE-HP could be effective for Hypersensitivity Pneumonitis. Additionally, the holistic management of pulmonary fibrosis highlights the importance of personalized care and education, which are components of the RISE-HP treatment. ^{1 2 3 4 5}

How is the RISE-HP treatment for Hypersensitivity Pneumonitis different from other treatments?

The RISE-HP treatment is unique because it focuses on self-management and education, similar to asthma self-management programs, which emphasize patient education and community support to improve health outcomes. This approach may be novel for Hypersensitivity Pneumonitis, as it integrates patient support and education into the treatment plan, rather than relying solely on medication. ^{6 7 8 9 10}

What is the purpose of this trial?

The central hypothesis is that a peer coach-delivered intervention that includes cognitive behavioral principles combined with theory-driven patient education will improve health-related quality of life (HRQOL) of patients with hypersensitivity pneumonitis (HP). The goal of this behavioral and educational intervention, RISE-HP, is to improve health-related quality of life in people who have hypersensitivity pneumonitis and assess feasibility and accessibility of this intervention. Patients with hypersensitivity pneumonitis (HP) experience uncertainty, feelings of anxiety and depression, and marked disruption to their lifestyle and home environment. Poor health-related quality of life (HRQOL) in HP is also driven in part by patients' profound lack of knowledge about the disease. Existing interventions for patients with HP do not target improvement in quality of life. Participants will complete either RISE-HP, a 10-session peer coach delivered behavioral and educational intervention to improve HRQOL in HP, or Staying Well, a 10-session general health education program.

Research Team

Kerri I Aronson, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Self-management for pulmonary fibrosis: Insights from people living with the disease and healthcare professionals. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Comprehensive Home Monitoring Program for Sarcoidosis. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Holistic management of patients with progressive pulmonary fibrosis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Experiences of older people following an acute exacerbation of chronic obstructive pulmonary disease: A phenomenological study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Facilitating education in pulmonary rehabilitation using the living well with COPD programme for pulmonary rehabilitation: a process evaluation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Promoting Interdisciplinary, Participatory Approaches to Address Childhood Asthma Disparities in an Urban Black Community. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Health Disparities: Interventions for Pulmonary Disease - A Narrative Review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Supporting patients self-managing respiratory health: a qualitative study on the impact of the Breathe Easy voluntary group network. [2020]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Trial of an asthma action plan in the Maori community of the Wairarapa. [2022]