Hypersensitivity PneumonitisRISE-HPNCT06811389
Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
A study testing Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) and Staying Well in people with Hypersensitivity Pneumonitis, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypersensitivity Pneumonitis
- What is being tested?
- Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) and Staying Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Meghana Ramineni, BA, 646-962-8130, mer4025@med.cornell.edu
Alicia Morris, (646) 962-2741, ajm2017@med.cornell.edu
About this study
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.
- Conditions
- Hypersensitivity Pneumonitis
- Being tested
- Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP), Staying Well
- Medical subject headings
- Alveolitis, Extrinsic Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)Behavioural
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 WellBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) | Experimental | 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. Receives: Behavioral: Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) |
| Attention Control | Other | 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. Receives: Behavioral: Staying Well |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition Rate
Measured: up to 10 weeks
Attendance rate
Measured: up to 10 weeks
Retention rate
Measured: 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.
Measured: Week 10
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start6 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm pilot randomized controlled trial. 40 participants with HP will be randomly assigned to either the intervention (20 participants) or the attention control arm (20 participants).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kerri I Aronson, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811389
- Sponsor's protocol ID
- 24-12028305
- Other IDs
- K23HL163394
- Acronym
- RISE-HP
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
- ClinicalTrials.gov ID
- NCT06811389
- Acronym / sponsor ID
- RISE-HP / 24-12028305
- Conditions
- Hypersensitivity Pneumonitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm pilot randomized controlled trial. 40 participants with HP will be randomly assigned to either the intervention (20 participants) or the attention control arm (20 participants).
| Arm | Type | Receives |
|---|---|---|
| Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) | Experimental | Behavioral: 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. |
| Attention Control | Other | Behavioral: Staying WellParticipants 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 may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) |
| Staying WellThe 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. | Behavioural | Attention Control |
Primary outcome
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
Time frame: Week 10
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.
12 secondary outcomes
Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)
Time frame: baseline, week 5
Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)
Time frame: baseline, week 10
Change in the Generalized Anxiety Disorder (GAD-7) score
Time frame: baseline, week 5
Change in the Generalized Anxiety Disorder (GAD-7) score
Time frame: baseline, week 10
Change in the Patient Health Questionnaire (PHQ-8) score
Time frame: baseline, week 5
Change in the Patient Health Questionnaire (PHQ-8) score
Time frame: baseline, week 10
Change in the Fatigue Severity Scale
Time frame: baseline, week 5
Change in the Fatigue Severity Scale
Time frame: baseline, week 10
Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"
Time frame: baseline, week 5
Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "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"
Time frame: baseline, week 5
Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"
Time frame: baseline, week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerri I Aronson, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) and Staying Well in people with Hypersensitivity Pneumonitis, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghana Ramineni, BA (646-962-8130, mer4025@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition Rate (time frame: up to 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.