Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:58 AM
Study NCT ID:
NCT07482150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Connect Trial: Connecting Hospital Patients to Alcohol Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'allocation concealment'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '6 months', 'description': '\\>50% of eligible individuals invited to the study give written informed consent'}, {'measure': 'Retention', 'timeFrame': '6 months', 'description': '\\>50% individuals recruited and randomized to the intervention, will attend to the intervention of seing the AUD therapist at least once'}, {'measure': 'Completion', 'timeFrame': '6 months', 'description': '\\>50% of all randomized study participants complete the follow-up interview and blood sample'}], 'secondaryOutcomes': [{'measure': 'AUD treatment engagement after 6 and 12 months', 'timeFrame': '12 months', 'description': 'No predefined goal'}, {'measure': 'Mortality after 6 and 12 months', 'timeFrame': '12 months', 'description': 'No predefined goal'}, {'measure': 'Change in drinks (containing 12 g ethanol) per last 30 days from baseline till 6 months after inclusion', 'timeFrame': '6 months'}, {'measure': 'Proportion with abstinence or light drinking (<10 drinks/week) last 30 days', 'timeFrame': '6 months', 'description': 'yes or no'}, {'measure': 'Change in blood phosphatidyl ethanol level from baseline to 6 months after inclusion', 'timeFrame': '6 months'}, {'measure': 'Change in motivation to cut down on alcohol (yes or no), calculated as the difference between baseline and 6 months follow-up', 'timeFrame': '6 months'}, {'measure': 'Number of AUD treatment sessions', 'timeFrame': '6 months'}, {'measure': 'Proportion initiating medical AUD therapy', 'timeFrame': '6 months'}, {'measure': 'Proportion receiving medical AUD treatment at 6- and 12 months follow up', 'timeFrame': '12 months'}, {'measure': 'Number of acute hospital admissions or emergency room visits at 6 and 12 months', 'timeFrame': '12 months'}, {'measure': 'Number of hospital outpatient visits at 6 and 12 months', 'timeFrame': '12 months'}, {'measure': '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', 'timeFrame': '3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol misuse treatment', 'inhospital alcohol care', 'pilot study', 'implementation study'], 'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '30665152', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38413539', 'type': 'BACKGROUND', 'citation': 'Incze 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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalised or seen in an outpatient clinic at SUH Køge\n* Full-filling international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use\n* Informed written consent\n* Being able to meet the AUD therapist in connection with a hospital visit with a health condition wholly or partly attributable to alcohol\n\nExclusion Criteria:\n\n* Ongoing specialized treatment for AUD\n* Not speaking Danish\n* Not living in the catchment area of Zealand University hospital\n* Age \\< 18 years\n* Enrolled in the Zealand alcohol-related liver disease cohort study'}, 'identificationModule': {'nctId': 'NCT07482150', 'briefTitle': 'The Connect Trial: Connecting Hospital Patients to Alcohol Care', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'The Connect Trial: Connecting Hospital Patients to Alcohol Care - a Randomized Controlled Feasibility Trial', 'orgStudyIdInfo': {'id': 'SJ-1130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '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.', 'interventionNames': ['Other: Guidance and leaflet on AUD treatment facilities outside the hospital']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '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.', 'interventionNames': ['Other: AUD treatment sessions with an outreach alcohol therapist at the hospital']}], 'interventions': [{'name': 'AUD treatment sessions with an outreach alcohol therapist at the hospital', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Intervention group']}, {'name': 'Guidance and leaflet on AUD treatment facilities outside the hospital', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Zealand University Hospital, Department of Medicine', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'centralContacts': [{'name': 'Gro Askgaard, MD, PhD', 'role': 'CONTACT', 'email': 'gras@regionsjaelland.dk', 'phone': '60142280'}], 'overallOfficials': [{'name': 'Gro Askgaard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sjaellands Universitetshospital Køge, Medicinsk Afdeling'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Gro Askgaard', 'investigatorAffiliation': 'Zealand University Hospital'}}}}