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NCT Number: NCT06811389

Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis

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.

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Key information

Conditions

Hypersensitivity Pneumonitis Alveolitis, Extrinsic Allergic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    Time frame: Week 10

    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

  1. Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)

    Time frame: baseline, week 5

    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.

  2. Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)

    Time frame: baseline, week 10

    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.

  3. Change in the Generalized Anxiety Disorder (GAD-7) score

    Time frame: baseline, week 5

    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

  4. Change in the Generalized Anxiety Disorder (GAD-7) score

    Time frame: baseline, week 10

    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

  5. Change in the Patient Health Questionnaire (PHQ-8) score

    Time frame: baseline, week 5

    Assesses depression. Score range from 1 to 27. 1-4 indicates minimal depression 5-9 indicates mild depression 10-14 indicates moderate depression 15-19 moderately severe depression 20-27 indicates severe depression

  6. Change in the Patient Health Questionnaire (PHQ-8) score

    Time frame: baseline, week 10

    Assesses depression. Score range from 1 to 27. 1-4 indicates minimal depression 5-9 indicates mild depression 10-14 indicates moderate depression 15-19 moderately severe depression 20-27 indicates severe depression

  7. Change in the Fatigue Severity Scale

    Time frame: baseline, week 5

    Assesses fatigue. 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle.

    The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.

    The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.

  8. Change in the Fatigue Severity Scale

    Time frame: baseline, week 10

    Assesses fatigue.

    9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle.

    The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.

    The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.

  9. Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"

    Time frame: baseline, week 5

    Assesses self-efficacy. PROMIS Self-Efficacy for Managing Chronic Conditions - Manage Emotions (short form 8 questions assessing confidence to manage/control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment and anger.)

    Scores range from 8 to 40. Higher scores indicate greater confidence in managing emotions.

  10. Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"

    Time frame: baseline, week 10

    Assesses self-efficacy. PROMIS Self-Efficacy for Managing Chronic Conditions - Manage Emotions (short form 8 questions assessing confidence to manage/control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment and anger.)

    Scores range from 8 to 40. Higher scores indicate greater confidence in managing emotions.

  11. Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"

    Time frame: baseline, week 5

    Assesses self-efficacy. PROMIS Self-Efficacy for Managing Chronic Conditions - Manage Daily Activities (short form 4 questions assessing confidence in performing various activities of daily living without assistance)

    Scores range from 4 to 20. Higher scores indicate greater confidence in managing daily activities.

  12. Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"

    Time frame: baseline, week 10

    Assesses self-efficacy. PROMIS Self-Efficacy for Managing Chronic Conditions - Manage Daily Activities (short form 4 questions assessing confidence in performing various activities of daily living without assistance)

    Scores range from 4 to 20. Higher scores indicate greater confidence in managing daily activities.

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Morris

CONTACT

[email protected]

(646)962-2741

Anna Tharakan, BS

CONTACT

[email protected]

(646)962-8130

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: RISE-HP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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