Hazardous DrinkingEFAR-SpainNCT02082990
Primary Care-based Facilitated Access to a Web Based Brief Intervention to Reduce Alcohol Consumption
A study testing Face-to-Face Brief Intervention and Online Brief Intervention in people with Hazardous Drinking, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Brief Interventions (BIs) for risky drinkers are an effective tool in primary care. Lack of time in daily practice has been identified as a barrier for the wide implementation of BI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hazardous Drinking
- What is being tested?
- Face-to-Face Brief Intervention and Online Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2014to 31 Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years old or over attended in primary care during the study period
- AUDIT-C 4 or above for women and 5 or above for men (in online screening)
Who cannot join
- Severe psychiatric disorders
- Serious visual impairment
- Terminal illness
- To have inadequate command of the Spanish or Catalan language
- AUDIT ≥ 18 in baseline assessment.
- Excluded patients will be referred to GPs to consider other interventions.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Care Centres of Institut Català de la Salut
Multiple Locations, Catalonia
About this study
Official title: A Randomised Controlled Non-inferiority Trial of Primary Care-based Facilitated Access to a Web Based Brief Intervention to Reduce Alcohol Consumption (EFAR-Spain)
Brief Interventions (BIs) for risky drinkers are an effective tool in primary care. Lack of time in daily practice has been identified as a barrier for the wide implementation of BI. There is growing evidence that e-health tools such as web based BIs can be an efficient alternative to standard face-to-face BIs and save time to general practitioners (GP).
The main aim of this study is to test non-inferiority of a web based BI for risky drinkers against a traditional face to face BI delivered by a general practitioner. We have designed a randomised controlled non-inferiority trial comparing both interventions, to be performed in primary care health centres in Catalonia, Spain.
Read more
Adults attending in primary care centres and willing to participate, will be invited to fill the short Alcohol Use Disorders Identification Test (AUDIT-C) in a specific website. Those screening positive and who accept to share the baseline data with their GP will be invited to an online assessment of their drinking and randomized to a standard BI with their GP or to the online BI.
Follow-up assessment will be conducted online at months 3 and 12, using the full Alcohol Use Disorder Identification Test (AUDIT) and the quality of life questionnaire (D5-EQD5). The main outcome will be the proportion of risky drinkers according to the AUDIT. Assuming a 30% reduction in the proportion of risky drinkers in the control group (classroom), allowing for an overall attrition of 10% of patients in the trial and non-inferiority assessed against a specified margin of 10%, it is estimated that 500 patients would be required in each group to give the test a 90% power (1-β) to reject the null hypothesis.
Read the detailed description
Trial design: A randomised non-inferiority controlled trial in primary care comparing facilitated access to a website for risky drinkers against a standard face-to-face BI. With the exception of the non-experimental intervention, all components of the study will be administered online to patients. Patients will be actively encouraged by their PHCP to access the application, which is available on the website of the programme 'Alcohol y Salud' (http:// www.alcoholysalud.cat), and will be provided with a unique registration code. The trial website is a Spanish adaptation of the English version of http://www.DownYourDrink.org.uk (DYD) developed in the UK, which includes modules for all the key trial components including screening, consent, assessment, randomisation and follow-up. It also incorporates the alcohol reduction website for the patients in the experimental group. The site has been adapted from the http://www.DownYourDrink.org.uk website developed for the DYD-RCT (randomised controlled trial).14 Details of DYD and the psychological theory that underpinned its development have been reported elsewhere. 21 Country-specific information such as recommended guidelines for alcohol intake, definitions of standard drinks and alcohol-related laws will be included. The website also incorporates a menu-driven facility to enable PHCP to customise automated messages to patients, for example, by adding photographs and pre-recorded messages. The personalised messages will appear to each patient using the log-in code provided by that practitioner.
Practitioner recruitment, training and incentives:
Recruitment will be based on the XaROH network. A 3 h seminar on new technologies, and EI and BI, introducing the trial, will be offered to all members of the XaROH, and those attending will be invited to sign up for the trial. In addition, several advertisements will be posted on the 'Beveu Menys' platform offering participation in the trial. In selecting practices, preference will be given to those with at least 5000 registered patients. Those practices that are selected as participants will be required to undergo a 1-day training programme. The training has four steps: (1) introduction to trial; (2) familiarisation with website; (3) update about EI and BI; and (4) practice in EI and BI (role-playing). Finally, participants will be encouraged to use the website and to tailor-make patient messages. Participating PHCPs will receive a financial incentive of €20 per patient recruited to the trial.
- Conditions
- Hazardous Drinking
- Being tested
- Face-to-Face Brief Intervention, Online Brief Intervention
- Keywords
- Alcohol-related disorders, Alcohol Drinking, e-health, Alcohol Use Disorder Test, Quality of Life
- Medical subject headings
- Alcohol-Related Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-Face Brief InterventionBehavioural
One face-to-face Brief Intervention which is provided by General Practitioner or Nurse
Online Brief InterventionBehavioural
Primary care-based facilitated access to an alcohol reduction website (Brief Intervention)
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Brief Intervention Group | Active comparator | One face-to-face Brief Intervention which is provided by General Practitioner or Nurse Receives: Behavioral: Face-to-Face Brief Intervention |
| Online Brief Intervention Group | Experimental | Primary care-based facilitated access to an alcohol reduction website (Brief Intervention) Receives: Behavioral: Online Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of risky drinkers according to the Alcohol Use Disorder Identification Test (AUDIT)
% of patients with > 7 scoring in AUDIT (month 3)
Measured: At month 3 after the randomisation
Secondary outcomes (2)
Proportion of risky drinkers according to the Alcohol Use Disorder Identification Test (AUDIT)
% of patients with > 7 scoring in AUDIT (month 12)
Measured: at month 12 after the randomisation
Quality of life EQ-5D-3L questionnaire
Increasing of QoL according to EQ5D53L
Measured: at month 3 and 12 after the randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startDec 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 Hazardous DrinkingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- August Pi Sunyer Biomedical Research Institute, Fundacion Clinic per a la Recerca Biomédica, Program on Substance Abuse, Public Health Agency, Government of Catalonia, University College, London, Instituto de Salud Carlos III, European Union
- Responsible party
- Principal investigator, Antoni Gual, Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Investigators
- Antoni Gual, MD. PhD, Principal investigator, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082990
- Sponsor's protocol ID
- PI042924
- Acronym
- EFAR-Spain
- Status last verified
- Aug 2018
- First submitted
- 5 Mar 2014
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez-Pelayo H, Wallace P, Segura L, Miquel L, Diaz E, Teixido L, Baena B, Struzzo P, Palacio-Vieira J, Casajuana C, Colom J, Gual A. A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): the study protocol. BMJ Open. 2014 Dec 31;4(12):e007130. doi: 10.1136/bmjopen-2014-007130.
PubMed 25552616
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Non-inferiority Trial of Primary Care-based Facilitated Access to a Web Based Brief Intervention to Reduce Alcohol Consumption (EFAR-Spain)
- ClinicalTrials.gov ID
- NCT02082990
- Acronym / sponsor ID
- EFAR-Spain / PI042924
- Conditions
- Hazardous Drinking
- Keywords
- Alcohol-related disorders, Alcohol Drinking, e-health, Alcohol Use Disorder Test, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- August Pi Sunyer Biomedical Research Institute, Fundacion Clinic per a la Recerca Biomédica, Program on Substance Abuse, Public Health Agency, Government of Catalonia, University College, London, Instituto de Salud Carlos III, European Union
- Study start
- Dec 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Mar 2014 (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.
Brief Interventions (BIs) for risky drinkers are an effective tool in primary care. Lack of time in daily practice has been identified as a barrier for the wide implementation of BI. There is growing evidence that e-health tools such as web based BIs can be an efficient alternative to standard face-to-face BIs and save time to general practitioners (GP).
The main aim of this study is to test non-inferiority of a web based BI for risky drinkers against a traditional face to face BI delivered by a general practitioner. We have designed a randomised controlled non-inferiority trial comparing both interventions, to be performed in primary care health centres in Catalonia, Spain.
Adults attending in primary care centres and willing to participate, will be invited to fill the short Alcohol Use Disorders Identification Test (AUDIT-C) in a specific website. Those screening positive and who accept to share the baseline data with their GP will be invited to an online assessment of their drinking and randomized to a standard BI with their GP or to the online BI.
Follow-up assessment will be conducted online at months 3 and 12, using the full Alcohol Use Disorder Identification Test (AUDIT) and the quality of life questionnaire (D5-EQD5). The main outcome will be the proportion of risky drinkers according to the AUDIT. Assuming a 30% reduction in the proportion of risky drinkers in the control group (classroom), allowing for an overall attrition of 10% of patients in the trial and non-inferiority assessed against a specified margin of 10%, it is estimated that 500 patients would be required in each group to give the test a 90% power (1-β) to reject the null hypothesis.
Detailed description
Trial design: A randomised non-inferiority controlled trial in primary care comparing facilitated access to a website for risky drinkers against a standard face-to-face BI. With the exception of the non-experimental intervention, all components of the study will be administered online to patients. Patients will be actively encouraged by their PHCP to access the application, which is available on the website of the programme 'Alcohol y Salud' (http:// www.alcoholysalud.cat), and will be provided with a unique registration code. The trial website is a Spanish adaptation of the English version of http://www.DownYourDrink.org.uk (DYD) developed in the UK, which includes modules for all the key trial components including screening, consent, assessment, randomisation and follow-up. It also incorporates the alcohol reduction website for the patients in the experimental group. The site has been adapted from the http://www.DownYourDrink.org.uk website developed for the DYD-RCT (randomised controlled trial).14 Details of DYD and the psychological theory that underpinned its development have been reported elsewhere. 21 Country-specific information such as recommended guidelines for alcohol intake, definitions of standard drinks and alcohol-related laws will be included. The website also incorporates a menu-driven facility to enable PHCP to customise automated messages to patients, for example, by adding photographs and pre-recorded messages. The personalised messages will appear to each patient using the log-in code provided by that practitioner.
Practitioner recruitment, training and incentives:
Recruitment will be based on the XaROH network. A 3 h seminar on new technologies, and EI and BI, introducing the trial, will be offered to all members of the XaROH, and those attending will be invited to sign up for the trial. In addition, several advertisements will be posted on the 'Beveu Menys' platform offering participation in the trial. In selecting practices, preference will be given to those with at least 5000 registered patients. Those practices that are selected as participants will be required to undergo a 1-day training programme. The training has four steps: (1) introduction to trial; (2) familiarisation with website; (3) update about EI and BI; and (4) practice in EI and BI (role-playing). Finally, participants will be encouraged to use the website and to tailor-make patient messages. Participating PHCPs will receive a financial incentive of €20 per patient recruited to the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Brief Intervention Group | Active comparator | Behavioral: Face-to-Face Brief InterventionOne face-to-face Brief Intervention which is provided by General Practitioner or Nurse |
| Online Brief Intervention Group | Experimental | Behavioral: Online Brief InterventionPrimary care-based facilitated access to an alcohol reduction website (Brief Intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years old or over attended in primary care during the study period
- AUDIT-C 4 or above for women and 5 or above for men (in online screening)
Key exclusion criteria (6 listed)
- Severe psychiatric disorders
- Serious visual impairment
- Terminal illness
- To have inadequate command of the Spanish or Catalan language
- AUDIT ≥ 18 in baseline assessment.
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 |
|---|---|---|
| Face-to-Face Brief InterventionOne face-to-face Brief Intervention which is provided by General Practitioner or Nurse | Behavioural | Face-to-Face Brief Intervention Group |
| Online Brief InterventionPrimary care-based facilitated access to an alcohol reduction website (Brief Intervention) | Behavioural | Online Brief Intervention Group |
Primary outcome
Proportion of risky drinkers according to the Alcohol Use Disorder Identification Test (AUDIT)
Time frame: At month 3 after the randomisation
% of patients with > 7 scoring in AUDIT (month 3)
2 secondary outcomes
Proportion of risky drinkers according to the Alcohol Use Disorder Identification Test (AUDIT)
Time frame: at month 12 after the randomisation
Quality of life EQ-5D-3L questionnaire
Time frame: at month 3 and 12 after the randomisation
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 17 Aug 2018.
- Derived from this study: PubMed 25552616Lopez-Pelayo H, Wallace P, Segura L, Miquel L, Diaz E, Teixido L, Baena B, Struzzo P, Palacio-Vieira J, Casajuana C, Colom J, Gual A. A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): the study protocol. BMJ Open. 2014 Dec 31;4(12):e007130. doi: 10.1136/bmjopen-2014-007130.
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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.
Antoni Gual, MD. PhD principal investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face Brief Intervention and Online Brief Intervention in people with Hazardous Drinking, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 inclusion and 6 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 17 Aug 2018. 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 Spain. 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?
Proportion of risky drinkers according to the Alcohol Use Disorder Identification Test (AUDIT) (time frame: At month 3 after the randomisation). 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 NCT02082990, 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 17 Aug 2018.