Alcohol-Related DisordersNCT04725552
Identifying and Managing Alcohol-related Health Problems in General Practice
A study testing 'Change' - an e-health intervention in people with Alcohol-Related Disorders and Alcohol Problem, run by Helse Stavanger HF at 4 sites in Norway.
Trial summary
The overall purpose of the proposed research is to increase patients' and general practitioners' (GPs') awareness of alcohol as a relevant factor for a wide variety of health problems in general practice, and enable earlier help and treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alcohol-Related Disorders, Alcohol Problem, Alcohol Drug Interaction
- What is being tested?
- 'Change' - an e-health intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 4 sitesNorway
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Registered patient with participating clinic, accepting that alcohol may be relevant for his/her health problem and wanting to participate
Who cannot join
- None, except age
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Sagene Lokalmedisinske senter
Oslo, 0485
Stavanger Medisinske Senter
Stavanger, 4007
Nytorget legesenter
Stavanger, 4013
Hillevågsdoktoren
Stavanger, 4016
About this study
Official title: Testing the Feasibility of Pragmatic Case Finding and a Supplemental Digital Intervention for Alcohol-related Health Problems in General Practice
The overall purpose of the proposed research is to increase patients' and general practitioners' (GPs') awareness of alcohol as a relevant factor for a wide variety of health problems in general practice, and enable earlier help and treatment. To achieve this, the investigators aim to test the feasibility of a pragmatic strategy for identification of alcohol-related health problems, and the feasibility of a web-based intervention between consultations, as a supplement to usual care in general practice.
Read the detailed description
Alcohol use is a major health problem, and there is a strong need for improved identification of and interventions for alcohol-related health problems. These constitute somatic and neuropsychiatric health problems, caused, precipitated, or complicated by alcohol use.
The investigators will especially recruit patients in late adulthood (60+), as this group may experience more barriers with digital interventions, and will have more health problems potentially affected by alcohol. The investigators have developed the identification strategy and the interventions in close collaboration with key stakeholders: patients and health care professionals.
The aim is to test the feasibility of interventions for hazardous (a quantity or pattern placing patients at risk for adverse health events) and harmful alcohol consumption (consumption resulting in adverse events), with two distinct components, namely pragmatic case finding and a digital self-administered intervention (called Endre) for use between consultations. The study will focus mainly on aspects related to acceptability, demand, implementation and practicality. The results from this feasibility study may give valuable knowledge on how this treatment approach should be adapted and implemented, and will indicate whether a full-scale RCT is warranted. This study is testing the feasibility of interventions intended to facilitate change for both patients (reduced alcohol consumption) and for physicians (improved addressing of alcohol and improved intervention delivery).
- Conditions
- Alcohol-Related Disorders, Alcohol Problem, Alcohol Drug Interaction, Alcohol Use Disorder
- Being tested
- 'Change' - an e-health intervention
- Keywords
- General practice, Feasibility, Implementation
- Medical subject headings
- Alcohol-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Change' - an e-health interventionBehavioural
The aim of the e-health intervention is to support the patient's change process and facilitate the doctor's ability to help. We plan for a web-application instead of a native application. A web-application enables use from mobile devices and from computers and is thus not dependent on a specific mode or system. Before including patients (postponed to September 2020 because of the Corona-virus pandemic), about 30 members of the general public have tested the e-health intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients offered the web-based intervention
Measured: Three months from start date
The number of patients completing baseline registration
Measured: Six months from start date
The number of patients using the intervention for at least one week
Measured: Six months from start date
The number of patients using the intervention for at least four weeks
Measured: Six months from start date
Secondary outcomes (4)
Changes alcohol consumption (AUDIT-C)
Changes in weekly alcohol consumption and binge drinking between baseline and 3 months
Measured: Three months from completed baseline registration
Changes in quality of life (RAND12)
Changes in quality of life between baseline and 3 months
Measured: Three months from completed baseline registration
Changes in mental distress (SCL5)
Changes in mental distress between baseline and 3 months
Measured: Three months from completed baseline registration
Changes in sleeping (Bergen Insomnia Scale)
Changes in sleeping between baseline and 3 months
Measured: Three months from completed baseline registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Feasibility study of a digital intervention supporting change in alcohol consumption for patients in general practice. The digital intervention is a supplement to usual care.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- University of Oslo, Northumbria University
- Responsible party
- Sponsor
- Investigators
- Torgeir G Lid, MD PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725552
- Sponsor's protocol ID
- 8/2020
- Status last verified
- Sep 2023
- First submitted
- 27 Jul 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Potthoff S, Brendryen H, Bosnic H, Bhardwaj-Gosling R, Iden KR, Nja ALM, O'Donnell A, Lid TG. Implementing pragmatic case finding to address alcohol use in general practice: a mixed methods feasibility study. Scand J Prim Health Care. 2026 Dec;44(1):2598835. doi: 10.1080/02813432.2025.2598835. Epub 2025 Dec 19.
PubMed 41414920
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of Pragmatic Case Finding and a Supplemental Digital Intervention for Alcohol-related Health Problems in General Practice
- ClinicalTrials.gov ID
- NCT04725552
- Acronym / sponsor ID
- 8/2020
- Conditions
- Alcohol-Related Disorders, Alcohol Problem, Alcohol Drug Interaction, Alcohol Use Disorder
- Keywords
- General practice, Feasibility, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- University of Oslo, Northumbria University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Jan 2021 (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 overall purpose of the proposed research is to increase patients' and general practitioners' (GPs') awareness of alcohol as a relevant factor for a wide variety of health problems in general practice, and enable earlier help and treatment. To achieve this, the investigators aim to test the feasibility of a pragmatic strategy for identification of alcohol-related health problems, and the feasibility of a web-based intervention between consultations, as a supplement to usual care in general practice.
Detailed description
Alcohol use is a major health problem, and there is a strong need for improved identification of and interventions for alcohol-related health problems. These constitute somatic and neuropsychiatric health problems, caused, precipitated, or complicated by alcohol use.
The investigators will especially recruit patients in late adulthood (60+), as this group may experience more barriers with digital interventions, and will have more health problems potentially affected by alcohol. The investigators have developed the identification strategy and the interventions in close collaboration with key stakeholders: patients and health care professionals.
The aim is to test the feasibility of interventions for hazardous (a quantity or pattern placing patients at risk for adverse health events) and harmful alcohol consumption (consumption resulting in adverse events), with two distinct components, namely pragmatic case finding and a digital self-administered intervention (called Endre) for use between consultations. The study will focus mainly on aspects related to acceptability, demand, implementation and practicality. The results from this feasibility study may give valuable knowledge on how this treatment approach should be adapted and implemented, and will indicate whether a full-scale RCT is warranted. This study is testing the feasibility of interventions intended to facilitate change for both patients (reduced alcohol consumption) and for physicians (improved addressing of alcohol and improved intervention delivery).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Feasibility study of a digital intervention supporting change in alcohol consumption for patients in general practice. The digital intervention is a supplement to usual care.
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Registered patient with participating clinic, accepting that alcohol may be relevant for his/her health problem and wanting to participate
Key exclusion criteria (1 listed)
- None, except age
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 |
|---|---|---|
| 'Change' - an e-health interventionThe aim of the e-health intervention is to support the patient's change process and facilitate the doctor's ability to help. We plan for a web-application instead of a native application. A web-application enables use from mobile devices and from computers and is thus not dependent on a specific mode or system. Before including patients (postponed to September 2020 because of the Corona-virus pandemic), about 30 members of the general public have tested the e-health intervention. | Behavioural | – |
Primary outcome
The number of patients offered the web-based intervention
Time frame: Three months from start date
The number of patients completing baseline registration
Time frame: Six months from start date
The number of patients using the intervention for at least one week
Time frame: Six months from start date
The number of patients using the intervention for at least four weeks
Time frame: Six months from start date
4 secondary outcomes
Changes alcohol consumption (AUDIT-C)
Time frame: Three months from completed baseline registration
Changes in quality of life (RAND12)
Time frame: Three months from completed baseline registration
Changes in mental distress (SCL5)
Time frame: Three months from completed baseline registration
Changes in sleeping (Bergen Insomnia Scale)
Time frame: Three months from completed baseline registration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 41414920Potthoff S, Brendryen H, Bosnic H, Bhardwaj-Gosling R, Iden KR, Nja ALM, O'Donnell A, Lid TG. Implementing pragmatic case finding to address alcohol use in general practice: a mixed methods feasibility study. Scand J Prim Health Care. 2026 Dec;44(1):2598835. doi: 10.1080/02813432.2025.2598835. Epub 2025 Dec 19.
- 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. This study is not recruiting at the moment.
Torgeir G Lid, MD PhD principal investigator
Helse Stavanger HF
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Change' - an e-health intervention in people with Alcohol-Related Disorders and Alcohol Problem, run by Helse Stavanger HF at 4 sites in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients offered the web-based intervention (time frame: Three months from start date). The study lists 4 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 NCT04725552, which also lists 1 linked publication.
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 15 Mar 2024.