Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
NCT ID: NCT06811389
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-05-06
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)
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.
Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)
The RISE-HP intervention consists of three components: peer support (peer coach), cognitive restructuring, and patient education. It consists of 10 weekly one-on-one meetings with a peer coach (a person with lived experience with HP who has been trained to deliver the content of the RISE-HP intervention to another person with HP).
The RISE-HP intervention delivered by peer coaches using the principles of cognitive behavioral therapy combined with theory driven patient education targets the health-related quality of life of patients living with hypersensitivity pneumonitis.
Attention Control
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.
Staying Well
The Staying Well intervention consists of 12 weeks of educational sessions. The participants can choose the 10 education sessions out of the 12 they want to cover with the research assistant. Participants will meet weekly with the research coordinator for an estimated 30-45 minutes per session.
Interventions
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Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)
The RISE-HP intervention consists of three components: peer support (peer coach), cognitive restructuring, and patient education. It consists of 10 weekly one-on-one meetings with a peer coach (a person with lived experience with HP who has been trained to deliver the content of the RISE-HP intervention to another person with HP).
The RISE-HP intervention delivered by peer coaches using the principles of cognitive behavioral therapy combined with theory driven patient education targets the health-related quality of life of patients living with hypersensitivity pneumonitis.
Staying Well
The Staying Well intervention consists of 12 weeks of educational sessions. The participants can choose the 10 education sessions out of the 12 they want to cover with the research assistant. Participants will meet weekly with the research coordinator for an estimated 30-45 minutes per session.
Eligibility Criteria
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Inclusion Criteria
* Age 18 or older.
* English Speaking.
* Willing to work with a peer coach.
* Have a working smart phone or tablet.
* Have access to the internet.
* Reside or live in the United States.
* Endorse verbal approval from treating physician to participate in patients' goal movement/physical activity.
* Meet one or more of the following criteria:
* Baseline score on the PHQ8 of \<20
Exclusion Criteria
* Younger than age 18
* Severe cognitive impairment as determined by their treating physician.
* Participants with severe depression (PHQ-8 score ≥20) will be ineligible for the study and will be referred to alternative sources of care.
* Anyone with documentation in their medical chart of an eating disorder, active substance use disorder, suicidality, homicidality, acute posttraumatic stress disorder, or episodes of mania or psychosis.
* Anyone who is determined to be severely ill or moribund by the treating clinician.
18 Years
100 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Kerri I Aronson, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-12028305
Identifier Type: -
Identifier Source: org_study_id
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