Identifying and Managing Alcohol-related Health Problems in General Practice

Testing the Feasibility of Pragmatic Case Finding and a Supplemental Digital Intervention for Alcohol-related Health Problems in General Practice

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.

Study Overview

• Status: Completed
• Conditions: Alcohol-Related Disorders; Alcohol Use Disorder; Alcohol Problem; Alcohol Drug Interaction
• Intervention / Treatment: Behavioral: 'Change' - an e-health intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0485
    • Sagene Lokalmedisinske senter
  • Stavanger, Norway, 4007
    • Stavanger Medisinske Senter
  • Stavanger, Norway, 4013
    • Nytorget legesenter
  • Stavanger, Norway, 4016
    • Hillevågsdoktoren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of patients offered the web-based intervention	Three months from start date
The number of patients completing baseline registration	Six months from start date
The number of patients using the intervention for at least one week	Six months from start date
The number of patients using the intervention for at least four weeks	Six months from start date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes alcohol consumption (AUDIT-C)	Changes in weekly alcohol consumption and binge drinking between baseline and 3 months	Three months from completed baseline registration
Changes in quality of life (RAND12)	Changes in quality of life between baseline and 3 months	Three months from completed baseline registration
Changes in mental distress (SCL5)	Changes in mental distress between baseline and 3 months	Three months from completed baseline registration
Changes in sleeping (Bergen Insomnia Scale)	Changes in sleeping between baseline and 3 months	Three months from completed baseline registration

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Collaborators: University of Oslo; Northumbria University
• Investigators: Principal Investigator: Torgeir G Lid, MD PhD, Helse Stavanger HF

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Implementation; General practice
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Alcoholism; Alcohol-Related Disorders
• Other Study ID Numbers: 8/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No