Pilot Clinical Trial of a Home-based Program of Rehabilitation With Health Coaching to Improve Outcomes in Post-intensive Care Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Completion of home-based rehabilitation program
研究概览
简要总结
The purpose of this study is to gather information on the effectiveness of a home-based rehabilitation program that also includes health coaching in patients who may suffer from post-intensive care syndrome (PICS). Many patients who are admitted to a hospital ICU suffer from new or worsening symptoms related to their medical condition and ICU care. These new or worsening symptoms may persist for some time and are collectively called post-intensive care syndrome (PICS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adults (age ≥ 18) with PICS defined as admitted to the ICU for more than 48 hours with any of the following conditions: respiratory failure of any cause requiring mechanical ventilation ≥ three days, any shock requiring vasopressors and/or inotropes, development of delirium during the ICU stay, , and cardiac arrest during the index hospital admission.
- •A HABC-M-SR score > 12 points.
排除标准
- •Any mechanical ventilation in the last two months before the index ICU admission
- •≥ 5 days in the ICU over the previous month before the index ICU admission
- •Receiving hospice or palliative care
- •Severe uncontrolled psychological or psychiatric disorders, e.g., schizophrenia, bipolar disorder, struggling to cope as a result of their personality disorder, uncontrolled substance abuse (alcoholism, illegal drugs) homelessness would make them unsuitable for the intervention
- •A co-morbidity so severe it would prevent the patient from engaging fully in the intervention/ control, e.g., progressive cancer, anoxic brain injury, severe rheumatoid arthritis or osteoarthritis, multiple sclerosis, chronic widespread pain syndrome, previous cerebral vascular event that the patient would not be able to participate in PR
- •Patients with moderate/severe cognitive impairment per medical records screening
- •Inability to obtain informed consent.
研究组 & 干预措施
Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching
5-10 subjects will be assigned to complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks to test feasibility of the home-based rehabilitation program. This will be the initial phase of the study prior to RCT phase.
干预措施: Health Coaching (Behavioral)
Home-Based Program of Rehabilitation and Health Coaching
Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks.
干预措施: Home-based Physical Rehabilitation (Behavioral)
Home-Based Program of Rehabilitation and Health Coaching
Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks.
干预措施: Health Coaching (Behavioral)
Usual Care
Subjects will receive clinical standard of care.
结局指标
主要结局
Completion of home-based rehabilitation program
时间窗: 12 weeks
Total number of subjects to complete the home-based rehabilitation program per protocol
Change in health related quality of life
时间窗: Baseline, 3 months
Measured by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) score. Questionnaire assess 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) on a 5 level severity scale of no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems.
次要结局
- Change in Anxiety and Depression(Baseline, 3 months)
- Change in Post-Traumatic Stress Disorder (PTSD) Symptoms(Baseline, 3 months)
- Change in cognition(Baseline, 3 months)
- Change in Daily Steps(Baseline, 3 months)
- Change in Sedentary Time(Baseline, 3 months)
- Change in Sleep time(Baseline, 3 months)
- Change in Physical activity(Baseline, 3 months)
- Healthcare Utilization(3 months)
研究者
Rodrigo Cartin-Ceba
Principal Investigator
Mayo Clinic