Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06811389

Conditions

Hypersensitivity Pneumonitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Staying Well

Study Details

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

Study ID

NCT06811389

Start date

May 6, 2025

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Anna Tharakan, BS

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

Alicia Morris

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

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Anna Tharakan, BS

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

Alicia Morris

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

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-05-28.