NCT04725552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 15, 2024

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

July 27, 2020

Last Update Submit

March 14, 2024

Conditions

Keywords

General practiceFeasibilityImplementation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Changes alcohol consumption (AUDIT-C)

    Three months from completed baseline registration

  • Changes in quality of life (RAND12)

    Three months from completed baseline registration

  • Changes in mental distress (SCL5)

    Three months from completed baseline registration

  • Changes in sleeping (Bergen Insomnia Scale)

    Three months from completed baseline registration

Interventions

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None, except age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sagene Lokalmedisinske senter

Oslo, 0485, Norway

Location

Stavanger Medisinske Senter

Stavanger, 4007, Norway

Location

Nytorget legesenter

Stavanger, 4013, Norway

Location

Hillevågsdoktoren

Stavanger, 4016, Norway

Location

Related Publications (1)

  • Potthoff S, Brendryen H, Bosnic H, Bhardwaj-Gosling R, Iden KR, Nja ALM, O'Donnell A, Lid TG. Implementing pragmatic case finding to address alcohol use in general practice: a mixed methods feasibility study. Scand J Prim Health Care. 2026 Dec;44(1):2598835. doi: 10.1080/02813432.2025.2598835. Epub 2025 Dec 19.

MeSH Terms

Conditions

Alcohol-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Torgeir G Lid, MD PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

January 26, 2021

Study Start

October 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

March 15, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations