Identifying and Managing Alcohol-related Health Problems in General Practice

Sponsor

Helse Stavanger HF (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04725552

Collaborator

University of Oslo (Other), Northumbria University (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol-Related Disorders Alcohol Problem Alcohol Drug Interaction Alcohol Use Disorder	Behavioral: 'Change' - an e-health intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Sagene Lokalmedisinske senter	Oslo	Norway	0485
2	Stavanger Medisinske Senter	Stavanger	Norway	4007
3	Nytorget legesenter	Stavanger	Norway	4013
4	Hillevågsdoktoren	Stavanger	Norway	4016