Skip to main content
OpenTrials
Completed

NCT Number: NCT04725552

Identifying and Managing 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sagene Lokalmedisinske senter, Oslo, Norway

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

'Change' - an e-health intervention

Behavioral

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.

Primary outcomes

  1. The number of patients offered the web-based intervention

    Time frame: Three months from start date

  2. The number of patients completing baseline registration

    Time frame: Six months from start date

  3. The number of patients using the intervention for at least one week

    Time frame: Six months from start date

  4. The number of patients using the intervention for at least four weeks

    Time frame: Six months from start date

Secondary outcomes

  1. Changes alcohol consumption (AUDIT-C)

    Time frame: Three months from completed baseline registration

    Changes in weekly alcohol consumption and binge drinking between baseline and 3 months

  2. Changes in quality of life (RAND12)

    Time frame: Three months from completed baseline registration

    Changes in quality of life between baseline and 3 months

  3. Changes in mental distress (SCL5)

    Time frame: Three months from completed baseline registration

    Changes in mental distress between baseline and 3 months

  4. Changes in sleeping (Bergen Insomnia Scale)

    Time frame: Three months from completed baseline registration

    Changes in sleeping between baseline and 3 months

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Northumbria University
  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 26, 2021
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.