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NCT06811389 | NOT YET RECRUITING | Hypersensitivity Pneumonitis


Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
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.

Condition or disease

Hypersensitivity Pneumonitis

Intervention/treatment

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

Staying Well

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
Actual Study Start Date : 2025-04
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 \>5 - \<20
  • * Baseline score on the GAD-7 of 5 or greater
  • * Baseline score on the FSS of 3 or greater
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) or severe anxiety (GAD-7 score ≥15) 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.

Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis

Location Details

NCT06811389


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Locations


Not yet recruiting

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10065

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