Study Stopped
Slow recruitment of study participants
SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy
SMILE
A Randomized, Pragmatic, Outcome-assessor-blinded Study of an SMS-message-based Lifestyle Intervention in Patients With Decompensated Liver Cirrhosis
2 other identifiers
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 19, 2021
November 1, 2021
3.2 years
June 21, 2016
November 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in The Model for End-Stage Liver Disease (MELD) score
The MELD is a reliable measure of mortality risk in patients with end-stage liver disease. The MELD is based on a mathematical equation. The MELD score is calculated using the following formula: MELD Score = 9.57 x ln (creatinine mg/dL) + 3.78 x ln(bilirubin mg/dL) + 11.2 x ln(INR)+ 6.43
week -12, 0, 12, 24
Secondary Outcomes (9)
10.2.1.1 Child-Pugh score
week -12, 0, 12, 24
Quality of life, SF-36v1
week -12, 0, 12, 24
SOKRATES questionnaire
week -12, 0, 12, 24
Sickness Impact Profile (SIP) questionnaire
week -12, 0, 12, 24
Six-Minute Walk Test
week -12, 0, 12, 24
- +4 more secondary outcomes
Other Outcomes (2)
Continuous Reaction Time
week -12, 0, 12, 24
Portosystemic Encephalopathy test
week -12, 0, 12, 24
Study Arms (2)
Usual care
ACTIVE COMPARATOR12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic
SMS-messages
EXPERIMENTAL12 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
Interventions
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).
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.
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
You may qualify if:
- Adult, i.e. age 18 years or above.
- 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.
- Has attended at least 50% of the scheduled sessions in the 12 week run-in physical exercise program
- Is the owner of a mobile phone capable of receiving SMS-messages
- Has signed informed consent
- Reads and speaks Danish
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marius Henriksenlead
Study Sites (1)
Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, 2400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian H Dall, PhD
University Hospital Bispebjerg and Frederiksberg
- PRINCIPAL INVESTIGATOR
Nanna M Jensen, PhD
University Hospital Bispebjerg and Frederiksberg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 23, 2016
Study Start
August 1, 2016
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
November 19, 2021
Record last verified: 2021-11