Identifying and Managing Alcohol-related Health Problems in General Practice

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04725552
• Other study ID #: 8/2020
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drug Interaction
• Alcohol Problem
• Alcohol Use Disorder
• Alcohol-Related Disorders
• Alcoholism

Intervention

Behavioral:
• 'Change' - an e-health intervention
The aim of the e-health intervention is to support the patient's change process and facilitate the doctor's ability to help. We plan for a web-application instead of a native application. A web-application enables use from mobile devices and from computers and is thus not dependent on a specific mode or system. Before including patients (postponed to September 2020 because of the Corona-virus pandemic), about 30 members of the general public have tested the e-health intervention.

Locations

Country	Name	City	State
Norway	Sagene Lokalmedisinske senter	Oslo
Norway	Hillevågsdoktoren	Stavanger
Norway	Nytorget legesenter	Stavanger
Norway	Stavanger Medisinske Senter	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
Helse Stavanger HF	Northumbria University, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients offered the web-based intervention		Three months from start date
Primary	The number of patients completing baseline registration		Six months from start date
Primary	The number of patients using the intervention for at least one week		Six months from start date
Primary	The number of patients using the intervention for at least four weeks		Six months from start date
Secondary	Changes alcohol consumption (AUDIT-C)	Changes in weekly alcohol consumption and binge drinking between baseline and 3 months	Three months from completed baseline registration
Secondary	Changes in quality of life (RAND12)	Changes in quality of life between baseline and 3 months	Three months from completed baseline registration
Secondary	Changes in mental distress (SCL5)	Changes in mental distress between baseline and 3 months	Three months from completed baseline registration
Secondary	Changes in sleeping (Bergen Insomnia Scale)	Changes in sleeping between baseline and 3 months	Three months from completed baseline registration