Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis

NCT06811389 | Recruiting DMC

• 2 other identifiers: 24-12028305K23HL163394
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersensitivity Pneumonitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)

  baseline, week 5

• Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)

  baseline, week 10

• Change in the Generalized Anxiety Disorder (GAD-7) score

  baseline, week 5

• Change in the Generalized Anxiety Disorder (GAD-7) score

  baseline, week 10

• Change in the Patient Health Questionnaire (PHQ-8) score

  baseline, week 5

Study Arms (2)

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.

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.

Behavioral: Staying Well

Interventions

Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) BEHAVIORAL

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.

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

Staying Well BEHAVIORAL

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.

Attention Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic

Interventions

Palliative Care; Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Kerri I Aronson, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Tharakan, BS

CONTACT

(646)962-8130; ant4034@med.cornell.edu

Alicia Morris

CONTACT

(646)962-2741; ajm2017@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)