AlcoholismPhase 1BIGNCT00982306
Brief Interventions in General Hospital (BIG)
A Phase 1 study testing Brief intervention in people with Alcoholism, run by Partnerships in Care at 1 site in United Kingdom.
Trial summary
Alcohol abuse is a widespread concern internationally with a significant threat to world health. Research suggests a relationship between heavy drinking and certain clinical presentations such as injuries, physical and psychiatric illnesses and frequent sickness absence from employment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Brief intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 294 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Apr 2012
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scores between 3-12 on FAST
- Admitted to hospital
- Speaks english
Who cannot join
- Under 18 years
- Cognitively impaired
- Medically Unfit
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Southern General Hospital
Glasgow, G51 4TF
Victoria Hardy, MSc, 0141 201 1593, victoria.hardy@ggc.scot.nhs.uk
Victoria Hardy, MSC
About this study
Official title: Brief Interventions for Heavy Alcohol Users Admitted to General Hospital
Alcohol abuse is a widespread concern internationally with a significant threat to world health. Research suggests a relationship between heavy drinking and certain clinical presentations such as injuries, physical and psychiatric illnesses and frequent sickness absence from employment. This research aims to establish whether brief interventions delivered to harmful and hazardous alcohol drinkers admitted to hospital impacts of their alcohol consumption levels on discharge from hospital.
Read the detailed description
Purpose To evaluate the effectiveness of brief interventions for hazardous and harmful alcohol abusers admitted to medical and surgical wards at the Southern General Hospital
Evidence for brief interventions in general hospital Further research is required to prove the benefits of brief interventions within general hospital, based on evidence from the Cochrane systematic review 'Brief interventions for heavy alcohol users admitted to general hospital wards' (McQueen et al 2009).
Links with national and international agendas The European Health Target12 supports a reduction in harm from alcohol drugs and tobacco. By the year 2015 the adverse health effects from the consumption of addictive substances such as alcohol should be reduced by all member states (European Health for all targets 1998) The Scottish government has set HEAT (Health improvement, efficacy and governance access and treatment) target for the NHS to deliver 149,449 alcohol brief intervention cumulatively over the period of 2008/9-2010/11 (Scottish Alcohol and Drugs Workforce 2008).
Research Design This study will employ a randomised control trial design. The primary outcome measure will be grams of alcohol consumed per week, measures will be taken at baseline, six months and one year post intervention. Secondary outcomes will consist of brief intervention's impact on hospital re-admission rates, attendance at A\&E and mortality rates.
- Conditions
- Alcoholism
- Being tested
- Brief intervention
- Keywords
- alcohol, brief interventions, counseling, harmful/hazardous alcohol drinkers
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief interventionBehavioural
20 minute one to one counseling session
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption in units
Measured: 6 months and one year
Secondary outcomes (1)
Hospital readmissions
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012 (estimated)
- Study completionApr 2012 (estimated)
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 AlcoholismStudies 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Partnerships in Care
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982306
- Sponsor's protocol ID
- SN08OC202
- Acronym
- BIG
- Status last verified
- Jul 2010
- First submitted
- 22 Sep 2009
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McQueen JM, Ballinger C, Howe TE. Factors associated with alcohol reduction in harmful and hazardous drinkers following alcohol brief intervention in Scotland: a qualitative enquiry. BMC Health Serv Res. 2017 Mar 8;17(1):181. doi: 10.1186/s12913-017-2093-7.
PubMed 28270194
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Interventions for Heavy Alcohol Users Admitted to General Hospital
- ClinicalTrials.gov ID
- NCT00982306
- Acronym / sponsor ID
- BIG / SN08OC202
- Conditions
- Alcoholism
- Keywords
- alcohol, brief interventions, counseling, harmful/hazardous alcohol drinkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Partnerships in CareUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 23 Sep 2009 (estimated)
- 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.
Alcohol abuse is a widespread concern internationally with a significant threat to world health. Research suggests a relationship between heavy drinking and certain clinical presentations such as injuries, physical and psychiatric illnesses and frequent sickness absence from employment. This research aims to establish whether brief interventions delivered to harmful and hazardous alcohol drinkers admitted to hospital impacts of their alcohol consumption levels on discharge from hospital.
Detailed description
Purpose To evaluate the effectiveness of brief interventions for hazardous and harmful alcohol abusers admitted to medical and surgical wards at the Southern General Hospital
Evidence for brief interventions in general hospital Further research is required to prove the benefits of brief interventions within general hospital, based on evidence from the Cochrane systematic review 'Brief interventions for heavy alcohol users admitted to general hospital wards' (McQueen et al 2009).
Links with national and international agendas The European Health Target12 supports a reduction in harm from alcohol drugs and tobacco. By the year 2015 the adverse health effects from the consumption of addictive substances such as alcohol should be reduced by all member states (European Health for all targets 1998) The Scottish government has set HEAT (Health improvement, efficacy and governance access and treatment) target for the NHS to deliver 149,449 alcohol brief intervention cumulatively over the period of 2008/9-2010/11 (Scottish Alcohol and Drugs Workforce 2008).
Research Design This study will employ a randomised control trial design. The primary outcome measure will be grams of alcohol consumed per week, measures will be taken at baseline, six months and one year post intervention. Secondary outcomes will consist of brief intervention's impact on hospital re-admission rates, attendance at A\&E and mortality rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scores between 3-12 on FAST
- Admitted to hospital
- Speaks english
Key exclusion criteria (3 listed)
- Under 18 years
- Cognitively impaired
- Medically Unfit
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 |
|---|---|---|
| Brief intervention20 minute one to one counseling session | Behavioural | – |
Primary outcome
Alcohol consumption in units
Time frame: 6 months and one year
1 secondary outcome
Hospital readmissions
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2010.
- Derived from this study: PubMed 28270194McQueen JM, Ballinger C, Howe TE. Factors associated with alcohol reduction in harmful and hazardous drinkers following alcohol brief intervention in Scotland: a qualitative enquiry. BMC Health Serv Res. 2017 Mar 8;17(1):181. doi: 10.1186/s12913-017-2093-7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brief intervention in people with Alcoholism, run by Partnerships in Care at 1 site in United Kingdom.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jul 2010. 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean McQueen, MSc (01292 886666, mcqueentraining@fsmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption in units (time frame: 6 months and one year). 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 NCT00982306, 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 29 Jul 2010.