Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP), Staying Well.
- Who it may be relevant to
- Registry conditions: Hypersensitivity Pneumonitis. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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 heal - Behavioral 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 measures
- 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]
Secondary outcome measures (12)
- Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD) [Time frame: baseline, week 5]
- Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD) [Time frame: baseline, week 10]
- Change in the Generalized Anxiety Disorder (GAD-7) score [Time frame: baseline, week 5]
- Change in the Generalized Anxiety Disorder (GAD-7) score [Time frame: baseline, week 10]
- Change in the Patient Health Questionnaire (PHQ-8) score [Time frame: baseline, week 5]
- Change in the Patient Health Questionnaire (PHQ-8) score [Time frame: baseline, week 10]
- Change in the Fatigue Severity Scale [Time frame: baseline, week 5]
- Change in the Fatigue Severity Scale [Time frame: baseline, week 10]
- Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions" [Time frame: baseline, week 5]
- Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions" [Time frame: baseline, week 10]
- Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities" [Time frame: baseline, week 5]
- Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities" [Time frame: baseline, week 10]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT06811389 · 24-12028305 · K23HL163394