Alcohol Use DisorderNCT07482150
The Connect Trial: Connecting Hospital Patients to Alcohol Care
A study testing AUD treatment sessions with an outreach alcohol therapist at the hospital and Guidance and leaflet on AUD treatment facilities outside the hospital in people with Alcohol Use Disorder, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- AUD treatment sessions with an outreach alcohol therapist at the hospital and Guidance and leaflet on AUD treatment facilities outside the hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2026to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital, Department of Medicine
Køge, 4600
Gro Askgaard, PhD MD, +45 29659981, gras@regionsjaelland.dk
About this study
Official title: 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).
- Conditions
- Alcohol Use Disorder
- Being tested
- AUD treatment sessions with an outreach alcohol therapist at the hospital, Guidance and leaflet on AUD treatment facilities outside the hospital
- Keywords
- alcohol misuse treatment, inhospital alcohol care, pilot study, implementation study
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUD treatment sessions with an outreach alcohol therapist at the hospitalOther
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.
Guidance and leaflet on AUD treatment facilities outside the hospitalOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Other: Guidance and leaflet on AUD treatment facilities outside the hospital |
| Intervention group | Experimental | 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. Receives: Other: AUD treatment sessions with an outreach alcohol therapist at the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
>50% of eligible individuals invited to the study give written informed consent
Measured: 6 months
Retention
>50% individuals recruited and randomized to the intervention, will attend to the intervention of seing the AUD therapist at least once
Measured: 6 months
Completion
>50% of all randomized study participants complete the follow-up interview and blood sample
Measured: 6 months
Secondary outcomes (12)
AUD treatment engagement after 6 and 12 months
No predefined goal
Measured: 12 months
Mortality after 6 and 12 months
No predefined goal
Measured: 12 months
Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion
Measured: 6 months
Proportion with abstinence or light drinking (<10 drinks/week) last 30 days
yes or no
Measured: 6 months
Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion
Measured: 6 months
Change in motivation to cut down on alcohol (yes or no), calculated as the difference between baseline and 6 months follow-up
Measured: 6 months
Number of AUD treatment sessions
Measured: 6 months
Proportion initiating medical AUD therapy
Measured: 6 months
Proportion receiving medical AUD treatment at 6- and 12 months follow up
Measured: 12 months
Number of acute hospital admissions or emergency room visits at 6 and 12 months
Measured: 12 months
Number of hospital outpatient visits at 6 and 12 months
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Mar 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gro Askgaard, Zealand University Hospital
- Investigators
- Gro Askgaard, Principal investigator, Sjaellands Universitetshospital Køge, Medicinsk Afdeling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482150
- Sponsor's protocol ID
- SJ-1130
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwarz AS, Nielsen B, Sogaard J, Sogaard Nielsen A. Making a bridge between general hospital and specialised community-based treatment for alcohol use disorder-A pragmatic randomised controlled trial. Drug Alcohol Depend. 2019 Mar 1;196:51-56. doi: 10.1016/j.drugalcdep.2018.12.017. Epub 2019 Jan 17.
PubMed 30665152Incze MA, Kelley AT, James H, Nolan S, Stofko A, Fordham C, Gordon AJ. Post-hospitalization Care Transition Strategies for Patients with Substance Use Disorders: A Narrative Review and Taxonomy. J Gen Intern Med. 2024 Apr;39(5):837-846. doi: 10.1007/s11606-024-08670-5. Epub 2024 Feb 27.
PubMed 38413539
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Connect Trial: Connecting Hospital Patients to Alcohol Care - a Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT07482150
- Acronym / sponsor ID
- SJ-1130
- Conditions
- Alcohol Use Disorder
- Keywords
- alcohol misuse treatment, inhospital alcohol care, pilot study, implementation study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 19 Mar 2026 (actual)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Guidance and leaflet on AUD treatment facilities outside the hospitalParticipants 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. |
| Intervention group | Experimental | Other: AUD treatment sessions with an outreach alcohol therapist at the hospitalParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| AUD treatment sessions with an outreach alcohol therapist at the hospitalParticipants 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. | Other | Intervention group |
| Guidance and leaflet on AUD treatment facilities outside the hospitalParticipants 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 | Control group |
Primary outcome
Recruitment
Time frame: 6 months
>50% of eligible individuals invited to the study give written informed consent
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
Completion
Time frame: 6 months
>50% of all randomized study participants complete the follow-up interview and blood sample
12 secondary outcomes
AUD treatment engagement after 6 and 12 months
Time frame: 12 months
Mortality after 6 and 12 months
Time frame: 12 months
Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion
Time frame: 6 months
Proportion with abstinence or light drinking (<10 drinks/week) last 30 days
Time frame: 6 months
Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion
Time frame: 6 months
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
Number of AUD treatment sessions
Time frame: 6 months
Proportion initiating medical AUD therapy
Time frame: 6 months
Proportion receiving medical AUD treatment at 6- and 12 months follow up
Time frame: 12 months
Number of acute hospital admissions or emergency room visits at 6 and 12 months
Time frame: 12 months
Number of hospital outpatient visits at 6 and 12 months
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 30665152Schwarz AS, Nielsen B, Sogaard J, Sogaard Nielsen A. Making a bridge between general hospital and specialised community-based treatment for alcohol use disorder-A pragmatic randomised controlled trial. Drug Alcohol Depend. 2019 Mar 1;196:51-56. doi: 10.1016/j.drugalcdep.2018.12.017. Epub 2019 Jan 17.
- Background: PubMed 38413539Incze MA, Kelley AT, James H, Nolan S, Stofko A, Fordham C, Gordon AJ. Post-hospitalization Care Transition Strategies for Patients with Substance Use Disorders: A Narrative Review and Taxonomy. J Gen Intern Med. 2024 Apr;39(5):837-846. doi: 10.1007/s11606-024-08670-5. Epub 2024 Feb 27.
- Individual participant dataSharing planned: No
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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.
Gro Askgaard principal investigator
Sjaellands Universitetshospital Køge, Medicinsk Afdeling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AUD treatment sessions with an outreach alcohol therapist at the hospital and Guidance and leaflet on AUD treatment facilities outside the hospital in people with Alcohol Use Disorder, run by Zealand University Hospital 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gro Askgaard, MD, PhD (60142280, gras@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07482150, which also lists 2 linked publications.
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 7 Oct 2026.