Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Attrition Rate [Срок оценки: up to 10 weeks]
• Attendance rate [Срок оценки: up to 10 weeks]
• Retention rate [Срок оценки: up to 10 weeks]
• Implementation Survey [Срок оценки: Week 10]

Вторичные конечные точки (12)

• Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD) [Срок оценки: baseline, week 5]
• Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD) [Срок оценки: baseline, week 10]
• Change in the Generalized Anxiety Disorder (GAD-7) score [Срок оценки: baseline, week 5]
• Change in the Generalized Anxiety Disorder (GAD-7) score [Срок оценки: baseline, week 10]
• Change in the Patient Health Questionnaire (PHQ-8) score [Срок оценки: baseline, week 5]
• Change in the Patient Health Questionnaire (PHQ-8) score [Срок оценки: baseline, week 10]
• Change in the Fatigue Severity Scale [Срок оценки: baseline, week 5]
• Change in the Fatigue Severity Scale [Срок оценки: baseline, week 10]
• Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions" [Срок оценки: baseline, week 5]
• Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions" [Срок оценки: baseline, week 10]
• Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities" [Срок оценки: baseline, week 5]
• Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities" [Срок оценки: baseline, week 10]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT06811389 · 24-12028305 · K23HL163394

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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