To Strengthen the Patients Hope After Discharge From the Intensive Care Unit - a Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Hope
研究概览
简要总结
The goal of this clinical trial is to evaluate an interventional program that aims to strengthen hope in intensive care unit (ICU) patients in the rehabilitation phase. The main questions it aims to answer are:
To develop and implement a follow-up service to strengthen hope in ICU patients, and to evaluate the effect on hope in a stepped wedge randomized trial.
To identify possible predictive factors (facilitators and barriers) associated with hope.
Participants will be asked to take part in an ICU follow-up service, a "Hope Intervention" consisting of digital individual- and group conversations. The program will address topics that are important for hope, such as active involvement, social relationships, believes and thoughts of the future.
We will compare the level of hope between participants who have completed the "Hope Intervention" to those that have not yet completed the program.
详细描述
The ICU patient's situation is challenging as they are acutely ill over a prolonged period of time and receive life sustaining treatment in the ICU.
Having hope and belief in a positive future, even when the prospects of such future are uncertain, may give strength and motivation and possibly improve the outcome in the rehabilitation phase. Hope is scarcely described in ICU patients.
Health care professionals need to learn how to best support ICU patients and promote hope during the rehabilitation period. Therefore, the main aim of the present study is to develop, implement and evaluate a follow up service to former ICU patients to strengthen their hope using a stepped wedge cluster randomized control intervention trial (SW-CRT). The secondary aim is to identify possible predictive factors associated with hope.
The intervention will start after hospital discharge and will be carried out in group sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years
- •ICU patient for > 48 hours
- •must be able to communicate verbally just after their ICU stay and be able to handle digital meetings
排除标准
- •Patients with severe cognitive impairment
- •Do not understand and speak Norwegian
- •Patients with major psychiatric challenges, suicidal attempts as a reason for ICU stay
- •Age over 85 years.
结局指标
主要结局
Hope
时间窗: Baseline and 1,2,3,4 and 5 months after baseline
Level of hope will be measured by Herth Hope Index (HHI). Baseline is measured after the patient has been discharged from the hospital. The HHI consists of 12 items measuring levels of hope related to cognitive and affective factors. Item scores range from 1 (strongly disagree) to 4 (strongly agree) and the total score ranges from 12 to 48. A high score indicates higher level of hope.
次要结局
- General Perceived Self-Efficacy Scale(Baseline and 1,2,3,4 and 5 months after baseline)
- Cognitive Failure Questionnaire(Baseline and 1,2,3,4 and 5 months after baseline)
- Memorial Symptom Assessment Scale(Baseline and 1,2,3,4 and 5 months after baseline)
- Social Provsion Scale(Baseline and 1,2,3,4 and 5 months after baseline)
- Charlson comorbidity Index(Within 2 months after inclucion)
研究者
Tone Rustøen
Reseacher, Professor
Oslo University Hospital