Alcohol ConsumptionALCO-AP20NCT04811729
Effectiveness of an Intervention in Patients With Excessive Alcohol Consumption
A study testing Motivational interview and Medical advice in people with Alcohol Consumption and Alcohol Use Disorder, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
Main objective: to verify the effectiveness of a brief intervention, based on the motivational interview (MI), in patients with excessive alcohol consumption assisted in Primary Care (PC). Design: a multicenter, randomized, cluster-controlled clinical trial with two parallel arms. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Alcohol Use Disorder
- What is being tested?
- Motivational interview and Medical advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2022to 30 Jul 2023
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
- -Inclusion criteria: 1.1.-Present risk alcohol consumption (28 Standard Drink Units -SDU- / week in men and 17 SDU / week in women 1.2.-Present 14 years or more; 3) consent to participate in the clinical trial.
- -Exclusion criteria: 2.1.Present health problems that prevent the intervention or its follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Brief Motivational Intervention in Addressing Excessive Alcohol Consumption in Primary Care
- Main objective: to verify the effectiveness of a brief intervention, based on the motivational interview (MI), in patients with excessive alcohol consumption assisted in Primary Care (PC).
- Design: a multicenter, randomized, cluster-controlled clinical trial with two parallel arms. PC professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): MI-based approach; 2) Control group (CG): usual care. At least 50 family doctors, residents and nurses will participate, recruiting PC patients (n = 394). GE intervention: Training program to acquire specific skills on approaching risky alcohol consumption. It will consist of a workshop, with two video recordings of consultations with simulated standardized patients, before and after it, with each participant receiving formative feedback at the end. -Intervention GC: medical advice that is usually performed in these patients. To measure the knowledge and attitude of professionals in dealing with patients with alcohol consumption, they will fill out a validated questionnaire. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale. -Study population: patients ≥14 years of age with risky consumption, detected by the professional in health centers in the province of Córdoba (Spain). Sample size: Assuming a loss rate of 5%, and the "cluster design effect", the number of subjects to be recruited is estimated at 394 (197 / group). Intervention control mechanism: each participant will be audio-recorded with a real patient in a randomly chosen visit, evaluating her skills with the EVEM scale. The follow-up period for each patient will be 12 months, with 4 visits (initial, per month, 3 months, and 6 months) and 4 interleaved telephone contacts. The main outcome variable will be the level of self-reported alcohol consumption and the AUDIT questionnaire score. -Statistical analysis by intention to treat. Descriptive analysis and initial comparability of the groups will be carried out, and the effect of the intervention (dependent variable: abstinence or consumption reduction and AUDIT score) will be evaluated through bivariate and multivariate analysis.
Read the detailed description
- Design: controlled, cluster-randomized, open-label, two-parallel-arm, multicenter clinical trial. Primary Care professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): they will apply an approach based on Motivational interview (MI), previously receiving a training program. 2) Control group (CG): usual care. They will receive an instructional program in order to avoid the "contamination" effect of the motivational approach. At least 50 professionals (family doctors, residents and nurses) will participate, each of whom will recruit (through opportunistic search) 9-10 PC patients.
- GE intervention: they will receive a 20-hour training program to acquire specific skills on the approach to patients with risky consumption, which will consist of a workshop, with two video recordings of consultations with simulated standardized patients, one before and others after the same, each participant receiving at the end a personalized training feedback.
- CG intervention: they will not receive the training program in MI, instructing them to carry out the medical advice that they usually carry out in these patients (informative model); They will also be videotaped, in order to verify that the approach they carry out is not motivational. On the other hand, both groups will receive an 8-hour workshop on detection, management and approach to the patient with excessive alcohol consumption, based on the recommendations and the action algorithm postulated by the PAPPS. To measure the knowledge and attitude of the professionals of both groups in relation to the approach of the patient with alcohol consumption, they will fill out a questionnaire validated by our group. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale, which has been validated by members of our group.
- Material and / or techniques to be used: The information of the participants will be obtained from tools already validated to assess risk alcohol consumption [Alcohol Use Disorder Identification Test (AUDIT), the motivational interview (EVEM questionnaire)] and satisfaction of the doctor-patient (PDRQ-9). In addition, the MCRS scale (Medical Condition Regard Scale) will be used to evaluate the attitude of health workers in the approach to alcohol, which has not been validated in Spanish to date. The Spanish validation process will be carried out by this research group. -Alcohol Use Disorder Identification Test (AUDIT). Tool designed to identify risky alcohol consumption and comprises 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 items (loss of control over consumption, increased relevance of consumption and morning consumption) and finally the third domain assesses harmful alcohol consumption through 4 questions (Feeling of guilt after consumption , memory gaps, alcohol-related injuries and environmental concern about consumption). A result equal to or greater than 8 is considered indicative of risky and harmful consumption, as well as a possible dependence on alcohol. -Evaluation Scale of the Motivational Interview (EVEM). 14-item scale with a score of 0 to 4, created and validated by members of our group, to assess encounters between professionals and patients in which MS is used. This scale analyzes: 1) empathy; 2) facilitation for the patient to position himself; 3) works in accordance with the patient; 4) use open questions; 5) perform reflective listening; 6) performs summaries; 7) validate the patient; 8) agreement of change objectives; 9) promotes the design of action / plan with the patient; 10) avoid discord with the patient; 11) develop a maintenance plan with the patient; 12) global spirit: evocation, collaboration, autonomy, understanding.
- Patient-Doctor Relationship Questionnaire (PDRQ-9). 9-question scale that assesses the doctor-patient relationship in clinical practice. Likert-type scale with 5 categories: 1 ("not at all appropriate"), 2 ("somewhat appropriate"), 3 ("appropriate"), 4 ("quite appropriate") and 5 ("very appropriate"). This scale has been validated in Spanish and will allow knowing the satisfaction of the patient in the alcohol approach developed by the health worker. -Medical Condition Regard Scale (MCRS). 11-question scale that assesses the attitude of health workers in the clinical approach. It is a Likert-type scale with 6 categories (1 = totally disagree, 6 = totally agree). It will be validated in Spanish by our research team.
- Location: Health Centers of the Andalus Health Service of the province of Córdoba (Spain).
- Study population: patients aged 14 or over with risky alcohol consumption (28 Standard Drink Units -SDU- / week in men and 17 SDU / week in women) users of PC services.
- Sample size: the main evaluation criterion will be the self-reported consumption by the patient. Based on a previous study carried out by members of our team, and to detect a difference of 20% between the percentage of patients in abstinence (partial or total) between the EG (37%) and the CG (20%); for an alpha error of 5%, a statistical power of 80%, the size would be 220 subjects (110 / group). Assuming a 5% loss rate and being a cluster randomization system, we will take into account the "design effect". Estimates of the intra-cluster correlation coefficient (ICC) in CCT by cluster in PC show that they are generally less than 0.05. This ICC translates, for a cluster size of 15, into a design effect that corresponds to a factor of 1.7. Assuming this value, the size would be 394 subjects to be recruited (197 in each group).
- Randomization: The randomization unit will be the healthcare professional and the intervention unit will be the patient. Professionals will be assigned randomly and equally (1:1) to one of the two study groups. -Mechanism of control of the interventions: each participant will also be videotaped with a real patient in a visit chosen at random, also evaluating her skills with the EVEM scale.
- The follow-up period for each patient will be 6 months, with 4 visits (initial, per month, at 3 months, and at 6 months), in addition to four interleaved telephone contacts. -Study variables: The main outcome variable will be the level of self-reported alcohol consumption (UBEs) and the score of the Alcohol Use Disorder Identification Test (AUDIT) questionnaire.
- Conditions
- Alcohol Consumption, Alcohol Use Disorder
- Being tested
- Motivational interview, Medical advice
- Keywords
- Alcohol use disorder
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
The participants will apply an approach based on the Motivational Interview (Rollnick, 2008) in patients with excessive alcohol consumption, previously receiving a training program
Medical adviceBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Intervention based on the Motivational Interview, previously receiving a training program Receives: Behavioral: Motivational interview |
| Control Group | Active comparator | Usual care based on a health counci Receives: Behavioral: Medical advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Self-reported alcohol consumption level
Measured: 12 months
AUDIT
Alcohol Use Disorder Identification Test (AUDIT) questionnaire score
Measured: 12 months
Alcohol Use Disorder Identification Test (AUDIT) questionnaire score
Tool designed to identify risky alcohol consumption and comprises 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 items (loss of control over consumption, increased relevance of consumption and morning consumption) and finally the third domain assesses harmful alcohol consumption through 4 questions (Feeling of guilt after consumption , memory gaps, alcohol-related injuries and environmental concern about consumption). A result equal to or greater than 8 is considered indicative of risky and harmful consumption, as well as a possible dependence on alcohol.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start18 Feb 2022
- Primary completion1 Apr 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies 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
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Collaborators
- Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Progress and Health Foundation, Córdoba and Guadalquivir Health District
- Responsible party
- Principal investigator, Luis A Perula, Hospital Universitario Reina Sofia de Cordoba
- Investigators
- Jose Angel Fernández García, Doctor, Principal investigator, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811729
- Sponsor's protocol ID
- ALCO-AP20
- Acronym
- ALCO-AP20
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief Motivational Intervention in Addressing Excessive Alcohol Consumption in Primary Care
- ClinicalTrials.gov ID
- NCT04811729
- Acronym / sponsor ID
- ALCO-AP20 / ALCO-AP20
- Conditions
- Alcohol Consumption, Alcohol Use Disorder
- Keywords
- Alcohol use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Collaborators
- Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Progress and Health Foundation, Córdoba and Guadalquivir Health District
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 23 Mar 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.
- Main objective: to verify the effectiveness of a brief intervention, based on the motivational interview (MI), in patients with excessive alcohol consumption assisted in Primary Care (PC).
- Design: a multicenter, randomized, cluster-controlled clinical trial with two parallel arms. PC professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): MI-based approach; 2) Control group (CG): usual care. At least 50 family doctors, residents and nurses will participate, recruiting PC patients (n = 394). GE intervention: Training program to acquire specific skills on approaching risky alcohol consumption. It will consist of a workshop, with two video recordings of consultations with simulated standardized patients, before and after it, with each participant receiving formative feedback at the end. -Intervention GC: medical advice that is usually performed in these patients. To measure the knowledge and attitude of professionals in dealing with patients with alcohol consumption, they will fill out a validated questionnaire. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale. -Study population: patients ≥14 years of age with risky consumption, detected by the professional in health centers in the province of Córdoba (Spain). Sample size: Assuming a loss rate of 5%, and the "cluster design effect", the number of subjects to be recruited is estimated at 394 (197 / group). Intervention control mechanism: each participant will be audio-recorded with a real patient in a randomly chosen visit, evaluating her skills with the EVEM scale. The follow-up period for each patient will be 12 months, with 4 visits (initial, per month, 3 months, and 6 months) and 4 interleaved telephone contacts. The main outcome variable will be the level of self-reported alcohol consumption and the AUDIT questionnaire score. -Statistical analysis by intention to treat. Descriptive analysis and initial comparability of the groups will be carried out, and the effect of the intervention (dependent variable: abstinence or consumption reduction and AUDIT score) will be evaluated through bivariate and multivariate analysis.
Detailed description
- Design: controlled, cluster-randomized, open-label, two-parallel-arm, multicenter clinical trial. Primary Care professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): they will apply an approach based on Motivational interview (MI), previously receiving a training program. 2) Control group (CG): usual care. They will receive an instructional program in order to avoid the "contamination" effect of the motivational approach. At least 50 professionals (family doctors, residents and nurses) will participate, each of whom will recruit (through opportunistic search) 9-10 PC patients.
- GE intervention: they will receive a 20-hour training program to acquire specific skills on the approach to patients with risky consumption, which will consist of a workshop, with two video recordings of consultations with simulated standardized patients, one before and others after the same, each participant receiving at the end a personalized training feedback.
- CG intervention: they will not receive the training program in MI, instructing them to carry out the medical advice that they usually carry out in these patients (informative model); They will also be videotaped, in order to verify that the approach they carry out is not motivational. On the other hand, both groups will receive an 8-hour workshop on detection, management and approach to the patient with excessive alcohol consumption, based on the recommendations and the action algorithm postulated by the PAPPS. To measure the knowledge and attitude of the professionals of both groups in relation to the approach of the patient with alcohol consumption, they will fill out a questionnaire validated by our group. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale, which has been validated by members of our group.
- Material and / or techniques to be used: The information of the participants will be obtained from tools already validated to assess risk alcohol consumption [Alcohol Use Disorder Identification Test (AUDIT), the motivational interview (EVEM questionnaire)] and satisfaction of the doctor-patient (PDRQ-9). In addition, the MCRS scale (Medical Condition Regard Scale) will be used to evaluate the attitude of health workers in the approach to alcohol, which has not been validated in Spanish to date. The Spanish validation process will be carried out by this research group. -Alcohol Use Disorder Identification Test (AUDIT). Tool designed to identify risky alcohol consumption and comprises 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 items (loss of control over consumption, increased relevance of consumption and morning consumption) and finally the third domain assesses harmful alcohol consumption through 4 questions (Feeling of guilt after consumption , memory gaps, alcohol-related injuries and environmental concern about consumption). A result equal to or greater than 8 is considered indicative of risky and harmful consumption, as well as a possible dependence on alcohol. -Evaluation Scale of the Motivational Interview (EVEM). 14-item scale with a score of 0 to 4, created and validated by members of our group, to assess encounters between professionals and patients in which MS is used. This scale analyzes: 1) empathy; 2) facilitation for the patient to position himself; 3) works in accordance with the patient; 4) use open questions; 5) perform reflective listening; 6) performs summaries; 7) validate the patient; 8) agreement of change objectives; 9) promotes the design of action / plan with the patient; 10) avoid discord with the patient; 11) develop a maintenance plan with the patient; 12) global spirit: evocation, collaboration, autonomy, understanding.
- Patient-Doctor Relationship Questionnaire (PDRQ-9). 9-question scale that assesses the doctor-patient relationship in clinical practice. Likert-type scale with 5 categories: 1 ("not at all appropriate"), 2 ("somewhat appropriate"), 3 ("appropriate"), 4 ("quite appropriate") and 5 ("very appropriate"). This scale has been validated in Spanish and will allow knowing the satisfaction of the patient in the alcohol approach developed by the health worker. -Medical Condition Regard Scale (MCRS). 11-question scale that assesses the attitude of health workers in the clinical approach. It is a Likert-type scale with 6 categories (1 = totally disagree, 6 = totally agree). It will be validated in Spanish by our research team.
- Location: Health Centers of the Andalus Health Service of the province of Córdoba (Spain).
- Study population: patients aged 14 or over with risky alcohol consumption (28 Standard Drink Units -SDU- / week in men and 17 SDU / week in women) users of PC services.
- Sample size: the main evaluation criterion will be the self-reported consumption by the patient. Based on a previous study carried out by members of our team, and to detect a difference of 20% between the percentage of patients in abstinence (partial or total) between the EG (37%) and the CG (20%); for an alpha error of 5%, a statistical power of 80%, the size would be 220 subjects (110 / group). Assuming a 5% loss rate and being a cluster randomization system, we will take into account the "design effect". Estimates of the intra-cluster correlation coefficient (ICC) in CCT by cluster in PC show that they are generally less than 0.05. This ICC translates, for a cluster size of 15, into a design effect that corresponds to a factor of 1.7. Assuming this value, the size would be 394 subjects to be recruited (197 in each group).
- Randomization: The randomization unit will be the healthcare professional and the intervention unit will be the patient. Professionals will be assigned randomly and equally (1:1) to one of the two study groups. -Mechanism of control of the interventions: each participant will also be videotaped with a real patient in a visit chosen at random, also evaluating her skills with the EVEM scale.
- The follow-up period for each patient will be 6 months, with 4 visits (initial, per month, at 3 months, and at 6 months), in addition to four interleaved telephone contacts. -Study variables: The main outcome variable will be the level of self-reported alcohol consumption (UBEs) and the score of the Alcohol Use Disorder Identification Test (AUDIT) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Motivational interviewIntervention based on the Motivational Interview, previously receiving a training program |
| Control Group | Active comparator | Behavioral: Medical adviceUsual care based on a health counci |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Motivational interviewThe participants will apply an approach based on the Motivational Interview (Rollnick, 2008) in patients with excessive alcohol consumption, previously receiving a training program | Behavioural | Experimental Group |
| Medical adviceUsual care | Behavioural | Control Group |
Primary outcome
Alcohol consumption
Time frame: 12 months
Self-reported alcohol consumption level
AUDIT
Time frame: 12 months
Alcohol Use Disorder Identification Test (AUDIT) questionnaire score
Alcohol Use Disorder Identification Test (AUDIT) questionnaire score
Time frame: 12 months
Tool designed to identify risky alcohol consumption and comprises 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 items (loss of control over consumption, increased relevance of consumption and morning consumption) and finally the third domain assesses harmful alcohol consumption through 4 questions (Feeling of guilt after consumption , memory gaps, alcohol-related injuries and environmental concern about consumption). A result equal to or greater than 8 is considered indicative of risky and harmful consumption, as well as a possible dependence on alcohol.
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 5 Feb 2024.
- 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.
Jose Angel Fernández García, Doctor principal investigator
Andaluz Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview and Medical advice in people with Alcohol Consumption and Alcohol Use Disorder, run by Hospital Universitario Reina Sofia de Cordoba 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?
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 5 Feb 2024. 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?
Alcohol consumption (time frame: 12 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?
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 5 Feb 2024.