Clinical trial NCT02811887: SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy
Official title: A Randomized, Pragmatic, Outcome-assessor-blinded Study of an SMS-message-based Lifestyle Intervention in Patients With Decompensated Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Cirrhosis, Alcoholic
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 description: 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.

Eligibility criteria: Inclusion Criteria:

1. Adult, i.e. age 18 years or above.
2. 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.
3. Has attended at least 50% of the scheduled sessions in the 12 week run-in physical exercise program
4. Is the owner of a mobile phone capable of receiving SMS-messages
5. Has signed informed consent
6. Reads and speaks Danish

Exclusion Criteria:

1. 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

Primary outcomes:
measure: Change in The Model for End-Stage Liver Disease (MELD) score
timeFrame: week -12, 0, 12, 24
Secondary outcomes:
measure: 10.2.1.1 Child-Pugh score
timeFrame: week -12, 0, 12, 24
measure: Quality of life, SF-36v1
timeFrame: week -12, 0, 12, 24
measure: SOKRATES questionnaire
timeFrame: week -12, 0, 12, 24
measure: Sickness Impact Profile (SIP) questionnaire
timeFrame: week -12, 0, 12, 24
measure: Six-Minute Walk Test
timeFrame: week -12, 0, 12, 24
measure: 30-seconds chair stand test
timeFrame: week -12, 0, 12, 24
measure: Muscle Power
timeFrame: week -12, 0, 12, 24
measure: Standard blood sample
timeFrame: week -12, 0, 12, 24
measure: Plasma concentrations of inflammatory markers
timeFrame: week -12, -6, 0
Other outcomes:
measure: Continuous Reaction Time
timeFrame: week -12, 0, 12, 24
measure: Portosystemic Encephalopathy test
timeFrame: week -12, 0, 12, 24
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Department of Physical and Occupational Therapy
Study officials:
affiliation: University Hospital Bispebjerg and Frederiksberg
name: Christian H Dall, PhD
role: STUDY_CHAIR
affiliation: University Hospital Bispebjerg and Frederiksberg
name: Nanna M Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: