Clinical trial NCT04725552: Identifying and Managing Alcohol-related Health Problems in General Practice
Official title: Testing the Feasibility of Pragmatic Case Finding and a Supplemental Digital Intervention for Alcohol-related Health Problems in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol-Related Disorders
Alcohol Problem
Alcohol Drug Interaction
Alcohol Use Disorder
Keywords: General practice
Feasibility
Implementation
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Oslo
name: Northumbria University
First posted: 2021-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* Registered patient with participating clinic, accepting that alcohol may be relevant for his/her health problem and wanting to participate

Exclusion Criteria:

* None, except age

Primary outcomes:
measure: The number of patients offered the web-based intervention
timeFrame: Three months from start date
measure: The number of patients completing baseline registration
timeFrame: Six months from start date
measure: The number of patients using the intervention for at least one week
timeFrame: Six months from start date
measure: The number of patients using the intervention for at least four weeks
timeFrame: Six months from start date
Secondary outcomes:
measure: Changes alcohol consumption (AUDIT-C)
timeFrame: Three months from completed baseline registration
measure: Changes in quality of life (RAND12)
timeFrame: Three months from completed baseline registration
measure: Changes in mental distress (SCL5)
timeFrame: Three months from completed baseline registration
measure: Changes in sleeping (Bergen Insomnia Scale)
timeFrame: Three months from completed baseline registration
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Sagene Lokalmedisinske senter
city: Stavanger
country: Norway
facility: Stavanger Medisinske Senter
city: Stavanger
country: Norway
facility: Nytorget legesenter
city: Stavanger
country: Norway
facility: Hillevågsdoktoren
Study officials:
affiliation: Helse Stavanger HF
name: Torgeir G Lid, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: