Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493773
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-28
Brief Title:
Systematic Referral to Alcohol Use Dependency Treatment in Patients With Alcohol-related Liver Disease a RCT
Sponsor:
Zealand University Hospital
Organization:
Zealand University Hospital
Study Overview
Official Title:
Systematic Referral to Physical and Online Alcohol Use Dependency Treatment in Patients Newly Diagnosed With Alcohol-related Liver Disease a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy of systematically referring newly diagnosed ALD patients to AUD treatment on alcohol abstinence after 6 months The investigators will conduct a randomized controlled superiority trial with parallel group design hypothesis blinding and blinded outcome assessment comparing A a referral to specialized AUD treatment intervention and B standard care control The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization
Detailed Description:
The investigators have designed a randomized controlled superiority trial to investigate the effectiveness of systematically offering AUD treatment in newly diagnosed ALD patients to increase the proportion that are abstaining from alcohol after 6 months compared to standard care The study will be embedded in an existing observational cohort from which already included participants will be used as controls in the RCT n 70 Please see Figure 1 for the flow of participants in the study From June 24 2024 the investigators will start to randomize eligible participants
Randomization will take place in connection with the first visit in the observational cohort study Study participants randomized as controls will receive standard care through their treating physicians which consists of individualized education on the nature of ALD as well as encouragement of alcohol use cessation
Patients in the intervention group will receive standard care in addition to an offer of referral to AUD treatment which includes contact from the AUD treatment center to the patients and the offer of both physical and online AUD treatment
Randomization will take place in connection with the first visit in the observational cohort study Study participants randomized as controls will receive standard care through their treating physicians which consists of individualized education on the nature of ALD as well as encouragement of alcohol use cessation
Patients in the intervention group will receive standard care in addition to an offer of referral to AUD treatment which includes contact from the AUD treatment center to the patients and the offer of both physical and online AUD treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None