Clinical Trial: SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Pragmatic, Outcome-assessor-blinded Study of an SMS-message-based Lifestyle Intervention in Patients With Decompensated Liver Cirrhosis

Brief Summary: 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.

Detailed Summary:

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.

Current Primary Outcome: Change in The Model for End-Stage Liver Disease (MELD) score [ Time Frame: week -12, 0, 12, 24 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 10.2.1.1 Child-Pugh score [ Time Frame: week -12, 0, 12, 24 ]
• Quality of life, SF-36v1 [ Time Frame: week -12, 0, 12, 24 ]
  10.2.2.1 Quality of life, SF-36v1 Short Form-36v1 is a standardised patient-reported instrument for use as a measure of health outcome and quality of life
• SOKRATES questionnaire [ Time Frame: week -12, 0, 12, 24 ]
  SOKRATES8a is a standardised patient-reported instrument for use as a measure of readiness for change in alcohol abusers
• Sickness Impact Profile (SIP) questionnaire [ Time Frame: week -12, 0, 12, 24 ]
  The Sickness Impact Profile (SIP) questionnaire is a 136 items generic health status measure
• Six-Minute Walk Test [ Time Frame: week -12, 0, 12, 24 ]
  The Six-Minute Walk-Test (6MWT) assesses general physical function. The test is performed in an undisturbed hospital corridor marked every 2 meters with coloured tape on the floor; starting and turning points marked by cones. Subjects are instructed to walk as fast as they can. They are allowed to stop or rest during the test if necessary and walking aids are allowed. The distance in meters covered during the 6 minutes is the outcome of the test.
• 30-seconds chair stand test [ Time Frame: week -12, 0, 12, 24 ]
  The 30-seconds chair stand test (30-s CST) is performed in an undisturbed room with hands crossed against the chest. It is one of the most important functional evaluation clinical tests because it measures lower body strength and relates it to the most demanding daily life activities. A 30-s CST consists of standing up and sitting down from a chair as many times as possible within 30 seconds.
• Muscle Power [ Time Frame: week -12, 0, 12, 24 ]
  The Leg Extensor Power Rig will be used to measure muscle power (force x velocity) in a non-invasive way. The participants will be in a seated position and a single explosive limb extension will accelerate a flywheel from rest. The participants will be instructed to kick the pedal as hard and fast as possible. Repeated kicks are performed, until a significant decline in power is observed. The kick with maximal power is the result of the text, and is recorded in Watts.
• Standard blood sample [ Time Frame: week -12, 0, 12, 24 ]
  As part of the usual assessment of the patients, standard blood samples (15ml) are drawn and analysed (4 visits x 15 ml = 60 ml per participant). The analyses include: Haemoglobin (Hgb), white blood cells, Bilirubin, ALAT, ASAT, INR, platelets, CRP, creatinine, urea, sodium, potassium, alkaline phosphatase albumin, coagulations factors II VII and X.
• Plasma concentrations of inflammatory markers [ Time Frame: week -12, -6, 0 ]
  EDTA plasma will be collected at before and after 12 weeks of supervised training intervention, and before and after a single exercise session in week 6 to analyse specific for cytokines/myokines interactions e.g. TNF alfa and IL-6.

Original Secondary Outcome:

• 10.2.1.1 Child-Pugh score [ Time Frame: week -12, 0, 12, 24 ]
• Quality of life, SF-36v1 [ Time Frame: week -12, 0, 12, 24 ]
  10.2.2.1 Quality of life, SF-36v1 Short Form-36v1 is a standardised patient-reported instrument for use as a measure of health outcome and quality of life
• SOKRATES questionnaire [ Time Frame: week -12, 0, 12, 24 ]
  SOKRATES8a is a standardised patient-reported instrument for use as a measure of readiness for change in alcohol abusers
• Sickness Impact Profile (SIP) questionnaire [ Time Frame: week -12, 0, 12, 24 ]
  The Sickness Impact Profile (SIP) questionnaire is a 136 items generic health status measure
• Six-Minute Walk Test [ Time Frame: week -12, 0, 12, 24 ]
  The Six-Minute Walk-Test (6MWT) assesses general physical function. The test is performed in an undisturbed hospital corridor marked every 2 meters with coloured tape on the floor; starting and turning points marked by cones. Subjects are instructed to walk as fast as they can. They are allowed to stop or rest during the test if necessary and walking aids are allowed. The distance in meters covered during the 6 minutes is the outcome of the test.
• 30-seconds chair stand test [ Time Frame: week -12, 0, 12, 24 ]
  The 30-seconds chair stand test (30-s CST) is performed in an undisturbed room with hands crossed against the chest. It is one of the most important functional evaluation clinical tests because it measures lower body strength and relates it to the most demanding daily life activities. A 30-s CST consists of standing up and sitting down from a chair as many times as possible within 30 seconds.
• Muscle Power [ Time Frame: week -12, 0, 12, 24 ]
  The Leg Extensor Power Rig will be used to measure muscle power (force x velocity) in a non-invasive way. The participants will be in a seated position and a single explosive limb extension will accelerate a flywheel from rest. The participants will be instructed to kick the pedal as hard and fast as possible. Repeated kicks are performed, until a significant decline in power is observed. The kick with maximal power is the result of the text, and is recorded in Watts.
• Standard blood sample [ Time Frame: week -12, 0, 12, 24 ]
  As part of the usual assessment of the patients, standard blood samples (15ml) are drawn and analysed (4 visits x 15 ml = 60 ml per participant). The analyses include: Haemoglobin (Hgb), white blood cells, Bilirubin, ALAT, ASAT, INR, platelets, CRP, creatinine, urea, sodium, potassium, alkaline phosphatase albumin, coagulations factors II VII and X.
• Plasma concentrations of inflammatory markers [ Time Frame: week -12, 6, 0 ]
  EDTA plasma will be collected at baseline and after 12 weeks of training intervention, and before and after a single exercise session in week 6 to analyse specific for cytokines/myokines interactions e.g. TNF alfa and IL-6.

Dates:
Date Received: June 21, 2016
Date Started: August 2016
Date Completion: December 2018
Last Updated: November 29, 2016
Last Verified: November 2016