SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy
NCT ID: NCT02811887
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2016-08-31
2019-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Usual care
12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic
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).
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.
SMS-messages
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
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).
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).
Interventions
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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).
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.
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).
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Marius Henriksen
OTHER
Responsible Party
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Marius Henriksen
Professor
Principal Investigators
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Christian H Dall, PhD
Role: STUDY_CHAIR
University Hospital Bispebjerg and Frederiksberg
Nanna M Jensen, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bispebjerg and Frederiksberg
Locations
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Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-16025360
Identifier Type: OTHER
Identifier Source: secondary_id
FYS003
Identifier Type: -
Identifier Source: org_study_id