NCT02811887

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Marius Henriksen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis, Alcoholic

Interventions

Type	Name	Description
BEHAVIORAL	Supervised exercise	A 12 week supervised and facility-based exercise training program. The program is facility based and supervised by a physiotherapist. The program runs 3 times weekly for 12 weeks. The exercise is group-based. The exercise program lasts approximately 1 hour and consists of a brief warm-up phase (bicycle ergometer at moderate intensity) followed by a circuit training program focusing on strength and endurance exercises of the large muscle groups (e.g. quadriceps).
OTHER	Usual Care	Participants allocated to usual care will receive instructions related to healthy living, alcohol absenteeism, and benefits of increased physical activity. The instructions will be provided by a physical therapist and/or a nurse, and will be given according to recommendations and local and national guidance. The participants are offered continued regular visits at the rehabilitation clinic, but no supervised physical exercise.
BEHAVIORAL	SMS-messages	Participants allocated to SMS-messages will receive the same intervention as usual care (see above) AND regular text messages via SMS over a 12-week period. The text messages will be unidirectional and will serve as motivational information but will not allow two-way communication with a researcher or health professional about clinical management. The messages will provide information, motivation, and support to adhere to a healthy lifestyle, alcohol absenteeism, and physical activity and will reinforce the information and instructions received at the face-to-face information (usual care).

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-10-01
• Completion: 2019-12-01
• First posted: 2016-06-23
• Last updated: 2021-11-19

Locations

1 site across 1 country: Denmark