About this trial
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
This trial does not accept healthy volunteersQualifiers
Have documented diagnosis of Hypersensitivity Pneumonitis by treating clinician.
Age 18 or older.
English Speaking.
Willing to work with a peer coach.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)
BehavioralThe 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
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Attrition Rate
Attendance rate
Retention rate
Implementation Survey
Assesses feasibility and acceptability. A 5-point Likert scale written based on CFIR framework. The overall score will be calculated by adding individual scores for the items. Lower scores will indicate lower acceptability, appropriateness, or feasibility of the intervention and higher scores will indicate better acceptability, appropriateness, or feasibility of the intervention.
Secondary outcomes
Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)
The KBILD is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale. It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)
The KBILD is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale. It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Change in the Generalized Anxiety Disorder (GAD-7) score
Assesses anxiety. Score range from 1 to 21. 1-4 indicates minimal anxiety 5-9 indicates mild anxiety 10-14 indicates moderate anxiety Greater than 15 indicates severe anxiety
Change in the Generalized Anxiety Disorder (GAD-7) score
Assesses anxiety. Score range from 1 to 21. 1-4 indicates minimal anxiety 5-9 indicates mild anxiety 10-14 indicates moderate anxiety Greater than 15 indicates severe anxiety
Sponsors and contacts
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Weill Medical College of Cornell University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator