Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis

Not Applicable

Recruiting

• Conditions: Hypersensitivity Pneumonitis

• Registration Number: NCT06811389
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-06
• Status Verified: 2025-05
• Study Start: 2025-05-06
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Attrition Rate	up to 10 weeks
Attendance rate	up to 10 weeks
Retention rate	up to 10 weeks
Implementation Survey	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)	baseline, week 10	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.
Change in the Generalized Anxiety Disorder (GAD-7) score	baseline, week 10	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
Change in the Patient Health Questionnaire (PHQ-8) score	baseline, week 10	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
Change in the Fatigue Severity Scale	baseline, week 10	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.
Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"	baseline, week 10	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.
Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"	baseline, week 10	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.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States