An interventional study of Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) and Staying Well in Hypersensitivity Pneumonitis, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Supportive care
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Among 11 studies in Alveolitis, Extrinsic Allergic with a site in United States — 3 open to participants now, 5 under way, none of them phase 3. Alveolitis, Extrinsic Allergic · United States.
Among the 11 studies in Alveolitis, Extrinsic Allergic with a site in United States, this one is the only one that started in 2025, is the only one with no phase, and was the 11th registered.
34 studies on the registry are indexed under Alveolitis, Extrinsic Allergic; 11 are open to participants now.
Browse Alveolitis, Extrinsic Allergic studies →3 of the 11 studies in Alveolitis, Extrinsic Allergic with a site in United States are open now. Recruiting first, the newest first:
University of Kansas Medical Center · Sites in United States
Ages 18+
University of Virginia · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Alveolitis, Extrinsic Allergic studies recruiting now, 3 set no upper age limit and none stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 42 is below the median of 51 across 16 interventional studies indexed under Alveolitis, Extrinsic Allergic.
Median enrollment 42 across the 3 interventional studies, 144 across the 8 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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1 of 11 have an industry lead sponsor. The 8 most frequent:
Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Weill Medical College of Cornell University has 2 studies filed under Alveolitis, Extrinsic Allergic — fewer than ten, so there is no comparison to draw.
2 of the studies in Alveolitis, Extrinsic Allergic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06811389Weill Medical College of Cornell UniversityReimagining Interventions for Support and Education in Hypersensitivity Pneumonitis | 2026-12 |
| NCT06329401Avalyn Pharma Inc.A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis | 2027-06 |
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Among the 11 studies in Alveolitis, Extrinsic Allergic with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)
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.
Behavioral: Staying Well
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.
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.
Attrition Rate
Time frame: up to 10 weeks
Attendance rate
Time frame: up to 10 weeks
Retention rate
Time frame: up to 10 weeks
Implementation Survey
Assesses feasibility and acceptability. A 5-point Likert scale written based on CFIR framework. The overall score will be calculated by adding individual scores for the items. Lower scores will indicate lower acceptability, appropriateness, or feasibility of the intervention and higher scores will indicate better acceptability, appropriateness, or feasibility of the intervention.
Time frame: Week 10
Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)
The KBILD is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale. It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Time frame: baseline, week 5
Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)
The KBILD is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale. It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Time frame: baseline, week 10
Change in the Generalized Anxiety Disorder (GAD-7) score
Assesses anxiety. Score range from 1 to 21. 1-4 indicates minimal anxiety 5-9 indicates mild anxiety 10-14 indicates moderate anxiety Greater than 15 indicates severe anxiety
Time frame: baseline, week 5
Change in the Generalized Anxiety Disorder (GAD-7) score
Assesses anxiety. Score range from 1 to 21. 1-4 indicates minimal anxiety 5-9 indicates mild anxiety 10-14 indicates moderate anxiety Greater than 15 indicates severe anxiety
Time frame: baseline, week 10
Change in the Patient Health Questionnaire (PHQ-8) score
Assesses depression. Score range from 1 to 27. 1-4 indicates minimal depression 5-9 indicates mild depression 10-14 indicates moderate depression 15-19 moderately severe depression 20-27 indicates severe depression
Time frame: baseline, week 5
Change in the Patient Health Questionnaire (PHQ-8) score
Assesses depression. Score range from 1 to 27. 1-4 indicates minimal depression 5-9 indicates mild depression 10-14 indicates moderate depression 15-19 moderately severe depression 20-27 indicates severe depression
Time frame: baseline, week 10
Change in the Fatigue Severity Scale
Assesses fatigue. 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
Time frame: baseline, week 5
Change in the Fatigue Severity Scale
Assesses fatigue. 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
Time frame: baseline, week 10
Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"
Assesses self-efficacy. PROMIS Self-Efficacy for Managing Chronic Conditions - Manage Emotions (short form 8 questions assessing confidence to manage/control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment and anger.) Scores range from 8 to 40. Higher scores indicate greater confidence in managing emotions.
Time frame: baseline, week 5
Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"
Assesses self-efficacy. PROMIS Self-Efficacy for Managing Chronic Conditions - Manage Emotions (short form 8 questions assessing confidence to manage/control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment and anger.) Scores range from 8 to 40. Higher scores indicate greater confidence in managing emotions.
Time frame: baseline, week 10
Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"
Assesses self-efficacy. PROMIS Self-Efficacy for Managing Chronic Conditions - Manage Daily Activities (short form 4 questions assessing confidence in performing various activities of daily living without assistance) Scores range from 4 to 20. Higher scores indicate greater confidence in managing daily activities.
Time frame: baseline, week 5
Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"
Assesses self-efficacy. PROMIS Self-Efficacy for Managing Chronic Conditions - Manage Daily Activities (short form 4 questions assessing confidence in performing various activities of daily living without assistance) Scores range from 4 to 20. Higher scores indicate greater confidence in managing daily activities.
Time frame: baseline, week 10
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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