A Randomized, Pragmatic, Outcome-assessor-blinded Study of an SMS-message-based Lifestyle Intervention in Patients With Decompensated Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in The Model for End-Stage Liver Disease (MELD) score
研究概览
简要总结
To investigate whether simple reminders about healthy lifestyle sent via mobile phone text messages can improve the liver cirrhosis severity and prognosis (as assessed by the MELD score supported by the Child-Pugh score) among patients with liver cirrhosis that have been through a 12-week supervised and facility-based physical exercise training program and in-patient rehabilitation.
详细描述
Physical exercise and other interventions focused on lifestyle factors have not only the potential to increase physical functioning and capacity, but also to affect fundamental aspects of disease, increase quality of life, and may even increase survival in patients with liver cirrhosis.
Instruction and advice about a healthy lifestyle and physical activity are attractive as it limits time spent on supervised rehabilitation at an outpatient clinic. Further, self-management can be attractive to society as it can conserve health care resources. However, instructions and advice can only be effective if the patients adhere to them, and there is a need for initiatives that enhance the motivation to follow the advice and change undesirable behaviours.
Mobile phone short-message service (SMS) messages are increasingly used to deliver interventions and enhance healthy behaviour. The technology is simple, cost-effective, can be automated, and can reach any mobile phone owner. In a recent systematic review, SMS-messages have been shown effective in a broad range of healthy behaviours, which was also highlighted in a randomized trial showing positive effects of lifestyle-focused SMS-messages on cardiovascular risk factors in patients with coronary heart disease. An SMS-message-based lifestyle intervention therefore seems like a feasible and effective means of enhancing motivation to follow advice about healthy lifestyle and physical activity among patients with liver cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult, i.e. age 18 years or above.
- •Is attending the liver cirrhosis rehabilitation clinic at Bispebjerg hospital; i.e., has alcohol-induced liver cirrhosis or hepatorenal syndrome and has at least once experienced severe decompensation in the form of hepatic encephalopathy or variceal haemorrhage.
- •Has attended at least 50% of the scheduled sessions in the 12 week run-in physical exercise program
- •Is the owner of a mobile phone capable of receiving SMS-messages
- •Has signed informed consent
- •Reads and speaks Danish
排除标准
- •Any condition that in the opinion of the investigator puts an otherwise eligible participant at increased risk by participation or otherwise make the person unfit for participation
结局指标
主要结局
Change in The Model for End-Stage Liver Disease (MELD) score
时间窗: week -12, 0, 12, 24
The MELD is a reliable measure of mortality risk in patients with end-stage liver disease. The MELD is based on a mathematical equation. The MELD score is calculated using the following formula: MELD Score = 9.57 x ln (creatinine mg/dL) + 3.78 x ln(bilirubin mg/dL) + 11.2 x ln(INR)+ 6.43
次要结局
- SOKRATES questionnaire(week -12, 0, 12, 24)
- Sickness Impact Profile (SIP) questionnaire(week -12, 0, 12, 24)
- Plasma concentrations of inflammatory markers(week -12, -6, 0)
- Quality of life, SF-36v1(week -12, 0, 12, 24)
- 10.2.1.1 Child-Pugh score(week -12, 0, 12, 24)
- 30-seconds chair stand test(week -12, 0, 12, 24)
- Six-Minute Walk Test(week -12, 0, 12, 24)
- Muscle Power(week -12, 0, 12, 24)
- Standard blood sample(week -12, 0, 12, 24)
研究者
Marius Henriksen
Professor
Frederiksberg University Hospital