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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Hypersensitivity Pneumonitis

Treatments: Behavioral: Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP); Behavioral: Staying Well

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06811389

24-12028305

K23HL163394 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

Attention Control

Other group

Description:

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.

Treatment:

Behavioral: Staying Well