Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Attendance rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP)
Participants will complete RISE-HP, 10-week peer-coach delivered, behavioral and educational intervention to improve quality of life among patients with hypersensitivity pneumonitis. This intervention will also utilize cognitive behavioral therapy, reframing negative thoughts into positive thoughts and actions.
干预措施: Re-imagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) (Behavioral)
Attention Control
Participants will complete a 10-week general health education program, "Staying Well", that will discuss topics like eating healthy and cholesterol. This program will be delivered by a member of the research team.
干预措施: Staying Well (Behavioral)
结局指标
主要结局
Attendance rate
时间窗: up to 10 weeks
Attrition Rate
时间窗: up to 10 weeks
Retention rate
时间窗: up to 10 weeks
Implementation Survey
时间窗: 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.
次要结局
- Change in the Kings Brief Interstitial Lung Disease Questionnaire (KBILD)(baseline, week 10)
- Change in the Generalized Anxiety Disorder (GAD-7) score(baseline, week 10)
- Change in the Patient Health Questionnaire (PHQ-8) score(baseline, week 10)
- Change in the Fatigue Severity Scale(baseline, week 10)
- Change in PROMIS measure of self-efficacy for managing Chronic Conditions- "managing emotions"(baseline, week 10)
- Change in PROMIS measure of self-efficacy for measure of self-efficacy for managing Chronic Conditions, "managing daily activities"(baseline, week 10)