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 2026-05-28.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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
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Alveolitis, Extrinsic Allergic→
Weill Medical College of Cornell University