Identifying and Managing Alcohol-related Health Problems in General Practice
Primary Purpose
Alcohol-Related Disorders, Alcohol Problem, Alcohol Drug Interaction
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
'Change' - an e-health intervention
Sponsored by
About this trial
This is an interventional other trial for Alcohol-Related Disorders focused on measuring General practice, Feasibility, Implementation
Eligibility Criteria
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
Sites / Locations
- Sagene Lokalmedisinske senter
- Stavanger Medisinske Senter
- Nytorget legesenter
- Hillevågsdoktoren
Outcomes
Primary Outcome Measures
The number of patients offered the web-based intervention
The number of patients completing baseline registration
The number of patients using the intervention for at least one week
The number of patients using the intervention for at least four weeks
Secondary Outcome Measures
Changes alcohol consumption (AUDIT-C)
Changes in weekly alcohol consumption and binge drinking between baseline and 3 months
Changes in quality of life (RAND12)
Changes in quality of life between baseline and 3 months
Changes in mental distress (SCL5)
Changes in mental distress between baseline and 3 months
Changes in sleeping (Bergen Insomnia Scale)
Changes in sleeping between baseline and 3 months
Full Information
NCT ID
NCT04725552
First Posted
July 27, 2020
Last Updated
June 7, 2022
Sponsor
Helse Stavanger HF
Collaborators
University of Oslo, Northumbria University
1. Study Identification
Unique Protocol Identification Number
NCT04725552
Brief Title
Identifying and Managing Alcohol-related Health Problems in General Practice
Official Title
Testing the Feasibility of Pragmatic Case Finding and a Supplemental Digital Intervention for Alcohol-related Health Problems in General Practice
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
Collaborators
University of Oslo, Northumbria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Alcohol Problem, Alcohol Drug Interaction, Alcohol Use Disorder
Keywords
General practice, Feasibility, Implementation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
'Change' - an e-health intervention
Intervention Description
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 Outcome Measure Information:
Title
The number of patients offered the web-based intervention
Time Frame
Three months from start date
Title
The number of patients completing baseline registration
Time Frame
Six months from start date
Title
The number of patients using the intervention for at least one week
Time Frame
Six months from start date
Title
The number of patients using the intervention for at least four weeks
Time Frame
Six months from start date
Secondary Outcome Measure Information:
Title
Changes alcohol consumption (AUDIT-C)
Description
Changes in weekly alcohol consumption and binge drinking between baseline and 3 months
Time Frame
Three months from completed baseline registration
Title
Changes in quality of life (RAND12)
Description
Changes in quality of life between baseline and 3 months
Time Frame
Three months from completed baseline registration
Title
Changes in mental distress (SCL5)
Description
Changes in mental distress between baseline and 3 months
Time Frame
Three months from completed baseline registration
Title
Changes in sleeping (Bergen Insomnia Scale)
Description
Changes in sleeping between baseline and 3 months
Time Frame
Three months from completed baseline registration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torgeir G Lid, MD PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sagene Lokalmedisinske senter
City
Oslo
ZIP/Postal Code
0485
Country
Norway
Facility Name
Stavanger Medisinske Senter
City
Stavanger
ZIP/Postal Code
4007
Country
Norway
Facility Name
Nytorget legesenter
City
Stavanger
ZIP/Postal Code
4013
Country
Norway
Facility Name
Hillevågsdoktoren
City
Stavanger
ZIP/Postal Code
4016
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Identifying and Managing Alcohol-related Health Problems in General Practice
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