Liver Cirrhosis, AlcoholicSMILENCT02811887
SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy
A study testing Supervised exercise and SMS-messages in people with Liver Cirrhosis, Alcoholic, run by Marius Henriksen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Alcoholic
- What is being tested?
- Supervised exercise and SMS-messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, 2400
About this study
Official title: A Randomized, Pragmatic, Outcome-assessor-blinded Study of an SMS-message-based Lifestyle Intervention in Patients With Decompensated Liver Cirrhosis
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.
Read the 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
- Being tested
- Supervised exercise, Usual Care, SMS-messages
- Medical subject headings
- Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseBehavioural
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 CareOther
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-messagesBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | 12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic Receives: Behavioral: Supervised exercise; Other: Usual Care |
| SMS-messages | Experimental | 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 Receives: Behavioral: Supervised exercise; Behavioral: SMS-messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week -12, 0, 12, 24
Secondary outcomes (9)
10.2.1.1 Child-Pugh score
Measured: week -12, 0, 12, 24
Quality of life, SF-36v1
10.2.2.1 Quality of life, SF-36v1 Short Form-36v1 is a standardised patient-reported instrument for use as a measure of health outcome and quality of life
Measured: week -12, 0, 12, 24
SOKRATES questionnaire
SOKRATES8a is a standardised patient-reported instrument for use as a measure of readiness for change in alcohol abusers
Measured: week -12, 0, 12, 24
Sickness Impact Profile (SIP) questionnaire
The Sickness Impact Profile (SIP) questionnaire is a 136 items generic health status measure
Measured: week -12, 0, 12, 24
Six-Minute Walk Test
The Six-Minute Walk-Test (6MWT) assesses general physical function. The test is performed in an undisturbed hospital corridor marked every 2 meters with coloured tape on the floor; starting and turning points marked by cones. Subjects are instructed to walk as fast as they can. They are allowed to stop or rest during the test if necessary and walking aids are allowed. The distance in meters covered during the 6 minutes is the outcome of the test.
Measured: week -12, 0, 12, 24
30-seconds chair stand test
The 30-seconds chair stand test (30-s CST) is performed in an undisturbed room with hands crossed against the chest. It is one of the most important functional evaluation clinical tests because it measures lower body strength and relates it to the most demanding daily life activities. A 30-s CST consists of standing up and sitting down from a chair as many times as possible within 30 seconds.
Measured: week -12, 0, 12, 24
Muscle Power
The Leg Extensor Power Rig will be used to measure muscle power (force x velocity) in a non-invasive way. The participants will be in a seated position and a single explosive limb extension will accelerate a flywheel from rest. The participants will be instructed to kick the pedal as hard and fast as possible. Repeated kicks are performed, until a significant decline in power is observed. The kick with maximal power is the result of the text, and is recorded in Watts.
Measured: week -12, 0, 12, 24
Standard blood sample
As part of the usual assessment of the patients, standard blood samples (15ml) are drawn and analysed (4 visits x 15 ml = 60 ml per participant). The analyses include: Haemoglobin (Hgb), white blood cells, Bilirubin, ALAT, ASAT, INR, platelets, CRP, creatinine, urea, sodium, potassium, alkaline phosphatase albumin, coagulations factors II VII and X.
Measured: week -12, 0, 12, 24
Plasma concentrations of inflammatory markers
EDTA plasma will be collected at before and after 12 weeks of supervised training intervention, and before and after a single exercise session in week 6 to analyse specific for cytokines/myokines interactions e.g. TNF alfa and IL-6.
Measured: week -12, -6, 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2019
- Study completionDec 2019
Why it stopped: Slow recruitment of study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cirrhosis, AlcoholicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Christian H Dall, PhD, Study chair, University Hospital Bispebjerg and FrederiksbergNanna M Jensen, PhD, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811887
- Sponsor's protocol ID
- FYS003
- Other IDs
- H-16025360
- Acronym
- SMILE
- Status last verified
- Nov 2021
- First submitted
- 21 Jun 2016
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pragmatic, Outcome-assessor-blinded Study of an SMS-message-based Lifestyle Intervention in Patients With Decompensated Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02811887
- Acronym / sponsor ID
- SMILE / FYS003
- Conditions
- Liver Cirrhosis, Alcoholic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment of study participants
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Supervised exercise, Other: Usual Care12 weeks of supervised physical exercise followed by usual care in the outpatient liver cirrhosis rehabilitation clinic |
| SMS-messages | Experimental | Behavioral: Supervised exercise, Behavioral: SMS-messages12 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exerciseA 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). | Behavioural | SMS-messages, Usual care |
| Usual CareParticipants 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. | Other | Usual care |
| SMS-messagesParticipants 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). | Behavioural | SMS-messages |
Primary outcome
Change in The Model for End-Stage Liver Disease (MELD) score
Time frame: week -12, 0, 12, 24
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
9 secondary outcomes
10.2.1.1 Child-Pugh score
Time frame: week -12, 0, 12, 24
Quality of life, SF-36v1
Time frame: week -12, 0, 12, 24
SOKRATES questionnaire
Time frame: week -12, 0, 12, 24
Sickness Impact Profile (SIP) questionnaire
Time frame: week -12, 0, 12, 24
Six-Minute Walk Test
Time frame: week -12, 0, 12, 24
30-seconds chair stand test
Time frame: week -12, 0, 12, 24
Muscle Power
Time frame: week -12, 0, 12, 24
Standard blood sample
Time frame: week -12, 0, 12, 24
Plasma concentrations of inflammatory markers
Time frame: week -12, -6, 0
Results and safety
The study was stopped early (reason given: Slow recruitment of study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian H Dall, PhD study chair
University Hospital Bispebjerg and Frederiksberg
Nanna M Jensen, PhD principal investigator
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise and SMS-messages in people with Liver Cirrhosis, Alcoholic, run by Marius Henriksen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment of study participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Model for End-Stage Liver Disease (MELD) score (time frame: week -12, 0, 12, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.