Improving Healthcare Outcomes With Early Detection of Liver Related Complications in Liver Cirrhosis Patients by Implementing a Telemedicine Care Pathway (myLIVERcoach): a Multicenter Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility defined by the number of recommendations to use this telemonitoring pathway by patients, caregivers and healthcare profesionals.
研究概览
简要总结
The goal of this multicenter feasibility study is to investigate the feasibility of our telemedicine platform (myLIVERcoach) in liver cirrhosis patients, according to liver cirrhosis patients, caregivers and healthcare professionals. The main question[s] it aims to answer are:
- What is the feasibility of a telemonitoring pathway according to patients, caregivers and healthcare professionals in liver cirrhosis care?
Secondary objectives: 2. What is the level of acceptability, usability, learnability and desirability of a telemonitoring pathway in liver cirrhosis care from the patients, caregivers and healthcare professionals' perspective? 3. What is the level of compliance of patients, caregivers and healthcare professionals using a telemonitoring pathway in liver cirrhosis care? 4. What is the occurrence of liver related complications in liver cirrhosis patients using a telemonitoring pathway? 5. What is the occurrence of clinical admissions and emergency concultations in liver cirrhosis patients using a telemonitoring pathway? 6. What is the mortality rate in liver cirrhosis patients using a telemonitoring pathway?
8. What is the effect of a telemonitoring pathway on patients perceived health, quality of life and work participation of liver cirrhosis patients?
Participants will be asked to use myLIVERcoach on top of standard care. According to disease stadium participants will receive different online questionnaires and measurements, focusing on early detection of complications and psychosocial and lifestyle factors. Participants are able to contact their healthcare professional and go through information about their disease as well.
After six months, participants will be asked to fill out a questionnaire regarding their experiences with myLIVERcoach in order to optimize the system. In addition the investigators will perform interviews with ten patients or caregivers and with healthcare professionals at the end of follow-up.
详细描述
Methods Study parameters/endpoints Main study parameter/endpoint Feasibility of this telemonitoring pathway in liver cirrhosis patients will be defined by results of the acceptability questionnaire, appendix B.
A score of ≥4.0 in ≥70% of patients, caregivers and healthcare professionals together will be defined as feasible.
Results of the question ''I would recommend the application to others'', see appendix B. A score ≥4.0 in ≥70% of patients, caregivers and healthcare professionals together is defined as significant satisfaction, one of the main aspects of adequate feasibility.
Feasibility will be evaluated in the interviews as well. The telemonitoring pathway will be defined feasible if ≥70% of interviewed patients and at least three (out of five) healthcare professionals find the telemonitoring of value in the domains: acceptance of implementation in standard liver cirrhosis care, support of self-management and adequate technological functioning.
Secondary study parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age or caregiver of a patient (both ≥ 18 years of age)
- •Liver cirrhosis, based on biopsy, fibroscan or diagnostic imaging data or caregiver of a patient with this diagnosis
排除标准
- •Inability to read or understand informed consent
- •Lack of internet access
- •History of or current hepatocellular carcinoma
- •History of or current hepatic metastasis
- •History of liver transplantation
研究组 & 干预措施
Patients using telemedicine on top of standard care
干预措施: telemedicine pathway (Device)
结局指标
主要结局
Feasibility defined by the number of recommendations to use this telemonitoring pathway by patients, caregivers and healthcare profesionals.
时间窗: 6 months
A score of ≥4.0 in ≥70% of patients, caregivers and healthcare professionals together will be defined as feasible. Using a likert scale, minimum value 1 (worst), maximum value 5 (best) Results of the question ''I would recommend the application to others'', see appendix B. A score ≥4.0 in ≥70% of patients, caregivers and healthcare professionals together is defined as significant satisfaction, one of the main aspects of adequate feasibility.
次要结局
- Compliance defined by ≥70% initiated questionnaires and e-learnings of actual provided questionnaires and e-learnings.(6 months)
- Compliance defined by ≥70% completed questionnaires and e-learnings of actual provided questionnaires and e-learnings.(6 months)
- Usability defined as a mean score of ≥4.0 in ≥70% patients, caregivers, and healthcare professionals together in the question ''It was easy to indicate my complaints with myLIVERcoach.''(6 months)
- Learnability defined as a mean score of ≥4.0 in ≥70% patients, caregivers, and healthcare professionals together in the question ''It was easy to learn how I had to use myLIVERcoach''.(6 months)
- Desirability defined as a mean score of ≥4.0 in ≥70% patients, caregivers, and healthcare professionals togethe in the question ''MyLIVERcoach meets my approval.''(6 months)
- Number of liver related complications(6 months)
- Clinical admissions(6 months)
- Emergency consultations(6 months)
- Mortaility(6 months)