Brief intervention in patients with esophageal varices (abnormal, enlarged veins in the tube that connects the throat and stomach)
| ISRCTN | ISRCTN15107567 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15107567 |
- Submission date
- 26/03/2021
- Registration date
- 24/04/2021
- Last edited
- 04/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Esophageal varices are abnormal, enlarged veins in the tube that connects the throat and stomach (esophagus). This condition occurs most often in people with serious liver diseases. Esophageal varices develop when normal blood flow to the liver is blocked by a clot or scar tissue in the liver.
The aim of the present study is to examine how motivational interviewing to reduce any alcohol use affects mortality among patients with esophageal varices caused by chronic liver diseases.
Who can participate?
All patients over the age of 18 with any chronic liver disease with esophageal varices.
What does the study involve?
Patients are interviewed using the Alcohol Use Disorders Identification Test and Addiction Severity Index before randomization to motivational interviewing (n=49) and no intervention (n=50). All participants are followed every third month for 2 years with structured interviews regarding their alcohol use. Primary outcome are mortality.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Capio StGöran Hospital, Medical Department, Stockholm, Sweden
When is the study starting and how long is it expected to run for?
December 2012 to December 2019
Who is funding the study?
Region Stockholm, Sweden
Who is the main contact?
Knut Stokkeland, M.D., Ph.D.,
Contact information
Scientific
Dept of Medicine
Capio S:t Göran Hospital
S:t Görans plan 1
Stockhom
11219
Sweden
| Phone | +46 (0)858703608 |
|---|---|
| charlotte.soderman@capiostgoran.se |
Study information
| Study design | Randomized controlled trial with two parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN15107567_PIS.pdf |
| Scientific title | Effects of a brief intervention on mortality in patients with liver cirrhosis complicated by esophageal varices – a randomized controlled trial |
| Study objectives | The aim of this study is to investigate whether MI directed against alcohol use reduces mortality among patients with any severe chronic liver disease, both alcohol-related and non-alcohol related. As a secondary aim, the impact of the intervention on alcohol consumption during follow-up is evaluated. |
| Ethics approval(s) | Approved 09/04/2013, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2013/187-31) |
| Health condition(s) or problem(s) studied | Alcohol use among patients with liver cirrhosis |
| Intervention | Brief intervention (a psychological counselling technique based on motivational interviewing) Following written informed consent and screening, included patients are subject to computerized randomization into two groups: one group receiving alcohol intervention and one control group receiving no intervention. The randomization are operated externally by the Karolinska Trial Alliance. The study is monitored according to good clinical practice by Karolinska Trial Alliance. The intervention group receives a single 45 minutes appointment using the MI technique, focusing on reducing the patient’s alcohol consumption. MI is a direct, client-centered counselling to elicit behavioral changes by helping clients to explore and resolve ambivalence. The technique builds on a non-judgmental stance; reflective listening; developing discrepancy; rolling with resistance, avoiding argument; and supporting efficacy to change. All patients are followed by time-line follow back telephone interviews by a study nurse every third month for two years and patients report alcohol consumption per day the last three months as detailed as possible. Alcohol consumption after intervention is explored as change in alcohol consumption between baseline and follow-up. Consumption is defined in terms of standard drinks containing 14 grams of alcohol. Binge drinking before inclusion is defined as any answer other than 0 on question E5 in the ASI. Binge drinking during follow up is defined as alcohol consumption equal to or more than five standard drinks per day, based on data from the TLFB interviews. The total amount of alcohol consumed and the amount of alcohol drunk per week during follow up are calculated based on TLFB data. Patients are interviewed using the Alcohol Use Disorders Identification Test and Addiction Severity Index before randomization to motivational interviewing or no intervention. All participants are followed every third month for 2 years with structured interviews regarding their alcohol use. |
| Intervention type | Behavioural |
| Primary outcome measure | Overall mortality rate is measured from the medical files which are based on the National Public Death Rate. The study is censored at the time of death or at the end of the study period. Death is registered even if the patients have dropped out of the study. |
| Secondary outcome measures | 1. Alcohol use measured using ASI, AUDIT at inclusion and TLFB on follow-up 2. Alcohol consumption after the intervention is explored as change in alcohol consumption between baseline and follow-up. Consumption are defined in terms of standard drinks containing 14 grams of alcohol |
| Overall study start date | 06/12/2012 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 84 |
| Total final enrolment | 99 |
| Key inclusion criteria | All patients over the age of 18 with any chronic liver disease with esophageal varices diagnosed by endoscopy or computer tomography at Capio S:t Görans Hospital, Stockholm |
| Key exclusion criteria | Hepatic encephalopathy too severe for interviewing |
| Date of first enrolment | 09/04/2013 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Stockholm
11229
Sweden
Sponsor information
Hospital/treatment centre
S:t Görans plan 1
Stockholm
11219
Sweden
| Phone | +46 (0)858703608 |
|---|---|
| charlotte.soderman@capiostgoran.se | |
| Website | http://ki.se/en/startpage |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available on reasonable request from Charlotte Söderman, M.D., Ph.D., Medical Department, Capio StGöran Hospital, StGörans plan 1, 112 19 Stockholm, Sweden, charlotte.soderman@capiostgoran.se |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/05/2021 | No | Yes | ||
| Protocol file | version v2 | 17/08/2015 | 04/05/2021 | No | No |
Additional files
- ISRCTN15107567_PIS.pdf
- uploaded 04/05/2021
- ISRCTN15107567_PROTOCOL_v2_17Aug2015.pdf
- uploaded 04/05/2021
Editorial Notes
04/05/2021: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version 2, 17 August 2015.
2. The participant information sheet was uploaded as an additional file.
23/04/2021: Trial's existence confirmed by Swedish Ethical Review Authority.
