Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)

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 Overview

• Status: Recruiting
• Conditions: Hypersensitivity Pneumonitis
• Intervention / Treatment: Behavioral: Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP); Behavioral: Staying Well

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicia Morris; Phone Number: (646)962-2741; Email: ajm2017@med.cornell.edu
• Study Contact Backup: Name: Anna Tharakan, BS; Phone Number: (646)962-8130; Email: ant4034@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Alicia Morris; Phone Number: (646) 962-2741; Email: ajm2017@med.cornell.edu
      • Contact: Anna Tharakan, BS; Phone Number: (646)962-8130; Email: ant4034@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Other: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attrition Rate		up to 10 weeks
Attendance rate		up to 10 weeks
Retention rate		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.	Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	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	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	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.	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.	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.	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.	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.	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.	baseline, week 10

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Kerri I Aronson, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Lung Diseases, Interstitial; Alveolitis, Extrinsic Allergic; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Palliative Care; Educational Status
• Other Study ID Numbers: 24-12028305; K23HL163394 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No