Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers (PELICAN)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 6
- 主要终点
- Adherence to Supplemental O2 Prescription
研究概览
简要总结
About 1 million individuals in the US have a prescription for supplemental oxygen (O2). Using O2 can prolong life and increase quality of life. Patients often do not use their oxygen as prescribed, which means that they are not benefiting as much as they could be from this therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for patients and CAregivers (PELICAN) will increase adherence to supplemental oxygen prescription and improve health in patients with chronic obstructive pulmonary disease (COPD).
详细描述
The COPD Foundation operates a peer-led telephone-based information line, but its effectiveness in promoting adherence to O2 therapy and patient-centered outcomes is unknown. Our overall hypothesis is that a patient-centered Peer-Led O2 InfoLine for patients and CAregivers (PELICAN) will increase adherence and improve health. We have developed a broad-based collaboration with patients/caregivers, advocacy groups, a national O2 supplier, and others to conduct a 3-arm pragmatic clinical trial, to evaluate the comparative effectiveness of proactive vs. reactive PELICAN interventions vs. usual care on adherence to O2 (primary outcome) and on other patient-centered outcomes (secondary outcomes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Physician diagnosis of COPD
- •Physician prescription for home O2 for 24hrs/day, 7 days/week
- •Willing to use home O
- •Working telephone number.
排除标准
- •Unable to read and speak English.
- •Discharge to home hospice or expected survival less than 6 months.
研究组 & 干预措施
Usual care
Written education material (basic)
干预措施: Written education material (basic) (Behavioral)
Proactive
Written education material (basic) Additional education material PELICAN-Proactive [In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)]
干预措施: Written education material (basic) (Behavioral)
Proactive
Written education material (basic) Additional education material PELICAN-Proactive [In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)]
干预措施: Additional education material (Behavioral)
Proactive
Written education material (basic) Additional education material PELICAN-Proactive [In addition to the usual care, participants will receive educational material and a proactive telephone peer coaching program (coaches call participants)]
干预措施: PELICAN-Proactive (Behavioral)
Reactive
Written education material (basic) Additional education material PELICAN-Reactive [In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)]
干预措施: Written education material (basic) (Behavioral)
Reactive
Written education material (basic) Additional education material PELICAN-Reactive [In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)]
干预措施: Additional education material (Behavioral)
Reactive
Written education material (basic) Additional education material PELICAN-Reactive [In addition to the usual care, participants will receive educational material and a reactive telephone peer coaching program (participants call coaches)]
干预措施: PELICAN-Reactive (Behavioral)
结局指标
主要结局
Adherence to Supplemental O2 Prescription
时间窗: 60 days
Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day
次要结局
- PROMIS - Physical Function(60 days)
- PROMIS - Fatigue(60 days)
- PROMIS - Satisfaction With Social Roles and Activities(60 days)
- PROMIS - Emotional Distress - Anxiety(60 days)
- PROMIS - Sleep Disturbance(60 days)
- PROMIS - Emotional Distress - Depression(60 days)
- PROMIS - Ability to Participate in Social Roles and Activities(60 days)
研究者
Jerry Krishnan
Professor of Medicine and Public Health; Associate Vice Chancellor for Population Health Sciences
University of Illinois at Chicago