Feasibility of an App to Measure Patient Stressors During Treatment in an Intensive Care Unit (ICU Feel Better App)- a Before-and-after Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Patient reported perceived severity of patient stressors
研究概览
简要总结
This study examines the feasibility and efficacy of a mobile application (app), which enables critically ill patients to report perceived patient stressors to their caregivers.
详细描述
For many critically ill patients, treatment in an intensive care unit (ICU) is very stressful, and for some of the patients it is a traumatic experience. The domains of patient stressors encompass physical stressors, mental health stressors, communication stressors, and environmental stressors. The experience of stressors during ICU is associated with a higher risk of worse outcomes including delirium, delayed recovery, and post-intensive care syndrome (PICS). In the context of inpatient intensive care medicine, health care professionals (HCP) have problems to correctly rate the extent of their patients' stress.
In this study, we examine the feasibility and efficacy of a stressor-reporting system based on a mobile application (app), which allows critically ill patients to evaluate by themselves the intensity of their stressors, and thus, to communicate their stress experience to HCPs.
In the first assessment phase of this study, outcome data of a cohort of n=20 patients will be collected (cohort A). Participants of cohort A will not use the ICU Feel Better App. In the second phase, outcome data of another n=20 patients (cohort B) will be collected. Participants of cohort B will have the opportunity to use the ICU Feel Better App from the second day after admission to the ICU until the day of discharge from ICU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients treated in an ICU
- •Duration of treatment ≥48h
- •Age: 18 years and older
- •Male, female, or divers gender
排除标准
- •Poor language skills
- •Statement in patient letter or living will that excludes participation
- •Participation in another prospective treatment study with indication delirium
- •Refusal of participation
结局指标
主要结局
Patient reported perceived severity of patient stressors
时间窗: Time until discharge from the intensive care unit, an expected average of 10 days
Patient reported perceived severity of patient stressors (Mean score of patient stressor list ). Range: 0-4, higher scores indicate higher stress. At day 2 or 3 of ICU treatment (before first use of the app) (t1), and at the day before or the day of discharge from ICU (t2).
次要结局
- Acute perceived stress(Time until discharge from the intensive care unit, an expected average of 10 days)
- Length of intensive care unit stay(Time until discharge from the intensive care unit, an expected average of 10 days)
- Mental distress(Time until discharge from the intensive care unit, an expected average of 10 days)
- State anxiety(Time until discharge from the intensive care unit, an expected average of 10 days)
- Pain(Time until discharge from the intensive care unit, an expected average of 10 days)
- Self-reported cognitive functioning(Time until discharge from the intensive care unit, an expected average of 10 days)
- Incidence of delirium(Time until discharge from the intensive care unit, an expected average of 10 days)
- Medication(Time until discharge from the intensive care unit, an expected average of 10 days)
- Treatment(Time until discharge from the intensive care unit, an expected average of 10 days)
- Diagnoses(Time until discharge from the intensive care unit, an expected average of 10 days)
- Acceptance of app(Time until discharge from the intensive care unit, an expected average of 10 days)
- Length of stay(Time until discharge from hospital, an expected average of 20 days)
- Diagnosis of post-intensive care syndrome (PICS)(Up to one month)
- Log data per patient(Time until discharge from the intensive care unit, an expected average of 10 days)
- Duration of mechanical ventilation(Time until discharge from the intensive care unit, an expected average of 10 days)
- APACHE II-Score(Time until discharge from the intensive care unit, an expected average of 10 days)
- Stressor intensity-(Time until discharge from the intensive care unit, an expected average of 10 days)
- Mode of intensive care unit admission(Time until discharge from the intensive care unit, an expected average of 10 days)
- Usability of app(Time until discharge from the intensive care unit, an expected average of 10 days)
- Support of study personal(Time until discharge from the intensive care unit, an expected average of 10 days)
- Relevance and understandability of app stressor items(Time until discharge from the intensive care unit, an expected average of 10 days)
研究者
Claudia Spies
Head of the Department of Anesthesiology and Operative intensive Care Medicine (CCM/CVK)
Charite University, Berlin, Germany