The Connect Trial: Connecting Hospital Patients to Alcohol Care

March 19, 2026 updated by: Gro Askgaard, Zealand University Hospital

The Connect Trial: Connecting Hospital Patients to Alcohol Care - a Randomized Controlled Feasibility Trial

The main objective of this pilot study is to assess feasibility of conducting a definitive RCT with concealed allocation, blinded outcome assessment and a 1:1 parallel group design of A) an invitation to meet an AUD therapist for up to 10 treatment sessions at the hospital in up to 6 months (intervention) compared to B) guidance on how to seek alcohol care in an AUD treatment centre in the community, outside of the hospital (control).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Zealand University Hospital, Department of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalised or seen in an outpatient clinic at SUH Køge
  • Full-filling international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use
  • Informed written consent
  • Being able to meet the AUD therapist in connection with a hospital visit with a health condition wholly or partly attributable to alcohol

Exclusion Criteria:

  • Ongoing specialized treatment for AUD
  • Not speaking Danish
  • Not living in the catchment area of Zealand University hospital
  • Age < 18 years
  • Enrolled in the Zealand alcohol-related liver disease cohort study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Participants randomised as controls will be offered a leaflet informing about different possibilities for alcohol misuse treatments and guidance on how to approach them (may include referral or help with doing an appointment, if possible according to the specific treatment center) in the catchment area of SUH Køge and Roskilde.
Other: Guidance and leaflet on AUD treatment facilities outside the hospital
Participants randomised as controls will be offered a leaflet informing about different possibilities for alcohol misuse treatments and guidance on how to approach them (may include referral or help with doing an appointment, if possible according to the specific treatment center) in the catchment area of SUH Køge and Roskilde
Experimental: Intervention group
Participants will be offered an AUD treatment session at the hospital the same or next day as they are enrolled in the study with an outreach alcohol therapist from a local AUD treatment facility. The alcohol therapist will be trained in motivational interviewing and cognitive behavioural therapy for AUD. The session will last for 20 to 60 minutes and can take place either at the department where the patient is admitted or elsewhere to ensure confidentiality. Up to 10 sessions at the hospital during 6 months after the baseline visit can be offered and after that, the participant can continue to meet with the same therapist in the community alcohol treatment facility. The participant will also be informed about other options for specialised alcohol treatment, group therapy, peer support and self-help groups.
Other: AUD treatment sessions with an outreach alcohol therapist at the hospital
Participants will be offered an AUD treatment session at the hospital the same or next day as they are enrolled in the study with an outreach alcohol therapist from a local AUD treatment facility. The alcohol therapist will be trained in motivational interviewing and cognitive behavioural therapy for AUD. The session will aim to motivate patients to reduce their alcohol consumption and set goals for AUD treatment. The alcohol therapist can recommend a medical therapy to support alcohol reduction or abstinence - this prescription will be undertaken by a hepatologist from the Department of Medicine and may be continued after discharge by patients´ general practitioner or physicians at the AUD treatment facility. Up to 10 sessions of up to 60 minutes of duration at the hospital during 6 months after the baseline visit can be offered and after that, the participant can continue to meet with the same therapist in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: 6 months
>50% of eligible individuals invited to the study give written informed consent
6 months
Retention
Time Frame: 6 months
>50% individuals recruited and randomized to the intervention, will attend to the intervention of seing the AUD therapist at least once
6 months
Completion
Time Frame: 6 months
>50% of all randomized study participants complete the follow-up interview and blood sample
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUD treatment engagement after 6 and 12 months
Time Frame: 12 months
No predefined goal
12 months
Mortality after 6 and 12 months
Time Frame: 12 months
No predefined goal
12 months
Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion
Time Frame: 6 months
6 months
Proportion with abstinence or light drinking (<10 drinks/week) last 30 days
Time Frame: 6 months
yes or no
6 months
Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion
Time Frame: 6 months
6 months
Number of AUD treatment sessions
Time Frame: 6 months
6 months
Proportion initiating medical AUD therapy
Time Frame: 6 months
6 months
Proportion receiving medical AUD treatment at 6- and 12 months follow up
Time Frame: 12 months
12 months
Number of acute hospital admissions or emergency room visits at 6 and 12 months
Time Frame: 12 months
12 months
Number of hospital outpatient visits at 6 and 12 months
Time Frame: 12 months
12 months
3- year follow-up, conducted through health care registries and AUD treatment facilities to look for incidence of alcohol-related morbidity and mortality, visits to general practitioner and hospital contacts
Time Frame: 3 years
3 years
Change in motivation to cut down on alcohol (yes or no), calculated as the difference between baseline and 6 months follow-up
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Gro Askgaard, Sjaellands Universitetshospital Køge, Medicinsk Afdeling

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-1130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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