Hypersensitivity Pneumonitis
Conditions
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.
Interventions
BEHAVIORALRe-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 health-related quality of life of patients living with hypersensitivity pneumonitis.
BEHAVIORALStaying 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.
Sponsors
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attrition Rate | up to 10 weeks | — |
| Attendance rate | up to 10 weeks | — |
| Retention rate | up to 10 weeks | — |
| Implementation Survey | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD) | 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. |
| Change in the Generalized Anxiety Disorder (GAD-7) score | 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 |
| Change in the Patient Health Questionnaire (PHQ-8) score | 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 |
| Change in the Fatigue Severity Scale | 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. |
| Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions" | 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. |
| Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities" | 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. |
Countries
United States
Contacts
CONTACTAnna Tharakan, BS
CONTACTAlicia Morris
PRINCIPAL_INVESTIGATORKerri I Aronson, MD
Weill Medical College of Cornell University
Outcome results
None listed