Clinical trial NCT06811389: Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
Official title: Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypersensitivity Pneumonitis
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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 \<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.

Primary outcomes:
measure: Attrition Rate
timeFrame: up to 10 weeks
measure: Attendance rate
timeFrame: up to 10 weeks
measure: Retention rate
timeFrame: up to 10 weeks
measure: Implementation Survey
timeFrame: Week 10
Secondary outcomes:
measure: Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)
timeFrame: baseline, week 5
measure: Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)
timeFrame: baseline, week 10
measure: Change in the Generalized Anxiety Disorder (GAD-7) score
timeFrame: baseline, week 5
measure: Change in the Generalized Anxiety Disorder (GAD-7) score
timeFrame: baseline, week 10
measure: Change in the Patient Health Questionnaire (PHQ-8) score
timeFrame: baseline, week 5
measure: Change in the Patient Health Questionnaire (PHQ-8) score
timeFrame: baseline, week 10
measure: Change in the Fatigue Severity Scale
timeFrame: baseline, week 5
measure: Change in the Fatigue Severity Scale
timeFrame: baseline, week 10
measure: Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"
timeFrame: baseline, week 5
measure: Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"
timeFrame: baseline, week 10
measure: Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"
timeFrame: baseline, week 5
measure: Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"
timeFrame: baseline, week 10
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Kerri I Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References: