Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis (NCT06811389) | Clinical Trial Compass
RecruitingNot Applicable
Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
United States42 participantsStarted 2025-05-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have documented diagnosis of Hypersensitivity Pneumonitis by treating clinician.
* 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:
* Does not have Hypersensitivity Pneumonitis
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Attrition Rate
Timeframe: up to 10 weeks
2
Attendance rate
Timeframe: up to 10 weeks
3
Retention rate
Timeframe: up to 10 weeks
4
Implementation Survey
Timeframe: Week 10
Trial details
NCT IDNCT06811389
SponsorWeill Medical College of Cornell University