Primary Care-based Facilitated Access to a Web Based Brief Intervention to Reduce Alcohol Consumption

NCT02082990 | Completed

• 1 other identifier: PI042924
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hazardous Drinking

Keywords

Alcohol-related disorders; Alcohol Drinking; e-health; Alcohol Use Disorder Test; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Proportion of risky drinkers according to the Alcohol Use Disorder Identification Test (AUDIT)

  % of patients with \> 7 scoring in AUDIT (month 3)

  At month 3 after the randomisation

Secondary Outcomes (2)

• Proportion of risky drinkers according to the Alcohol Use Disorder Identification Test (AUDIT)

  at month 12 after the randomisation

• Quality of life EQ-5D-3L questionnaire

  at month 3 and 12 after the randomisation

Other Outcomes (1)

• Implementation

  at month 3 after the randomisation

Study Arms (2)

Face-to-Face Brief Intervention Group

ACTIVE COMPARATOR

One face-to-face Brief Intervention which is provided by General Practitioner or Nurse

Behavioral: Face-to-Face Brief Intervention

Online Brief Intervention Group

EXPERIMENTAL

Primary care-based facilitated access to an alcohol reduction website (Brief Intervention)

Behavioral: Online Brief Intervention

Interventions

Face-to-Face Brief Intervention BEHAVIORAL

One face-to-face Brief Intervention which is provided by General Practitioner or Nurse

Face-to-Face Brief Intervention Group

Online Brief Intervention BEHAVIORAL

Primary care-based facilitated access to an alcohol reduction website (Brief Intervention)

Online Brief Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• August Pi Sunyer Biomedical Research Institute: collaborator
• Fundacion Clinic per a la Recerca Biomédica: collaborator
• Program on Substance Abuse, Public Health Agency, Government of Catalonia: collaborator
• University College, London: collaborator
• Instituto de Salud Carlos III: collaborator
• European Union: collaborator

Study Sites (1)

Primary Care Centres of Institut Català de la Salut

Multiple Locations, Catalonia, Spain

Location

Related Publications (1)

• 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.

  PMID: 25552616 DERIVED

Related Links

• BMJ Open: A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): the study protocol

MeSH Terms

Conditions

Alcohol-Related Disorders; Alcohol Drinking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Study Officials

• Antoni Gual, MD. PhD

  Institut d'Investigacions Biomèdiques August Pi i Sunyer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultor

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 11, 2014
• Study Start: December 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

ES (1)