Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorWeill Medical College of Cornell University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    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 health-related quality of life of patients living with hypersensitivity pneumonitis.

  • Staying Well

    Behavioral

    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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)Experimental treatment 1 intervention
Group B: Attention ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Attrition Rate

Time frame
up to 10 weeks
2

Attendance rate

Time frame
up to 10 weeks
3

Retention rate

Time frame
up to 10 weeks
4

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.

Time frame
Week 10

Secondary outcomes

1

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.

Time frame
baseline, week 5
2

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.

Time frame
baseline, week 10
3

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

Time frame
baseline, week 5
4

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

Time frame
baseline, week 10

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator