SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy (SMILE)

Marius Henriksen

Status: Terminated

Conditions: Liver Cirrhosis, Alcoholic

Treatments: Other: Usual Care; Behavioral: SMS-messages; Behavioral: Supervised exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02811887

FYS003

H-16025360 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Usual care

Active Comparator group

Description:

12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic

Treatment:

Other: Usual Care

Behavioral: Supervised exercise

SMS-messages

Experimental group

Description:

12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic + regular text messages via SMS over a 12-week period

Treatment:

Behavioral: SMS-messages

Behavioral: Supervised exercise