Plain English Summary
Background and study aims
Some people living with high blood pressure or mild to moderate depression also drink alcohol over medically recommended levels. If they change the amount or the way in which they drink their symptoms may improve. Brief advice is known to help people who drink excessively to reduce their alcohol consumption, and may also lead to improvements in associated high blood pressure or mental health problems. A large study of brief advice would show whether this is the case. To find out whether this is feasible, this study aims to find out how many patients could be invited and agree to take part in a study like this, how many would stay involved with the study, and whether they would find it practical and acceptable.
Who can participate?
Patients aged 18 and over and registered with GPs in the North East of England can take part if they are drinking alcohol over the UK recommended levels (21 units per week for men, 14 units per week for women) and are either diagnosed as hypertensive (high blood pressure) or have had mild to moderate depression or low mood.
What does the study involve?
The study involves filling in a questionnaire about alcohol and posting it back to the research team. If you choose to supply contact details on the questionnaire, a researcher will then contact you to arrange a 15-20 minute meeting at your GP surgery. At the meeting, the researcher will either measure your blood pressure using a standard cuff or ask a few questions about your mood. Participants will be randomly allocated to a control or an intervention group. Participants in the control group will receive a leaflet on high blood pressure or depression to take home. Intervention group participants will receive the same leaflets as the control group and the researcher may also briefly offer some advice about alcohol consumption and health. After 6 months you will be asked to meet again with the researcher at your GP surgery for 15 minutes to measure your blood pressure or ask questions about your mood, and to ask a few more questions about your alcohol consumption. This should take no longer than 15 minutes.
What are the possible benefits and risks of participating?
If you take part you will receive confidential advice on whether the amount you are drinking could be a risk to your health, as well as information about links between alcohol consumption and your condition (hypertension or depression) and how to reduce drinking to levels of low risk to health.
There are no anticipated risks involved in taking part. Any information about you which leaves the GP surgery will have your name and address removed.
Where is the study run from?
Study is coordinated by North Tyneside Primary Care Trust. The study will be run from GP surgeries in the North East of England.
When is the study starting and how long is it expected to run for?
The study started in August 2010 and ran until February 2012.
Who is funding the study?
North Tyneside NHS Primary Care Trust, UK.
Who is the main contact?
Dr Graeme Wilson, Project manager, Newcastle University
Trial website
Contact information
Type
Scientific
Primary contact
Prof Eileen Kaner
ORCID ID
Contact details
Institute of Health & Society
Newcastle University
Baddiley Clark Building
Richardson Road
Newcastle Upon Tyne
NE2 4AX
United Kingdom
eileen.kaner@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10SUBM001
Study information
Scientific title
Feasibility trial of brief intervention to improve alcohol consumption and Co-morBId outcomes in primary care patients with hypertension or mild to moderate depression
Acronym
ComBIne
Study hypothesis
The study aim is to investigate the feasibility of conducting larger future trials exploring brief intervention in primary care for heavy drinkers with co-morbid hypertension or depression.
Ethics approval
County Durham and Tees Valley NHS Research Ethics Committee, 23/07/2010, REC Reference Number 10/H0908/35
Study design
Two parallel two-arm cluster randomised controlled pilot trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Excessive alcohol drinking with co-morbid hypertension or mild to moderate depression
Intervention
1. In control arm, patients receive either an advice leaflet produced by the British Heart Foundation (hypertension trial) or a leaflet on depression produced by a regional NHS organisation (depression trial).
2. In intervention arm, participants receive the same leaflets as in the control arm plus a brief intervention involving a single practice-based 10 minute session of structured advice about reducing alcohol consumption levels, delivered by a trained research worker.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Rates of eligibility for the trial
2. Recruitment
Eligibility and recruitment of participants are recorded on the trial database at entry to the study; frequencies for each of these are calculated as a proportion of patients screened to give the outcome measures.
3. Retention
Retention of the participants in the trial is recorded on the database at the six-month follow-up; frequencies are calculated as a proportion of patients recruited to give this outcome measure.
Secondary outcome measures
1. Score on Alcohol Use Disorder Identification Tool (AUDIT)
2. Systolic and diastolic blood pressure (hypertension trial)
3. Score on Patient Health Questionnaire (PHQ-9, depression trial)
4. Acceptability of trial instruments and procedures
Each of these is measured at the baseline appointment, then again at the six month follow up appointment.
Overall trial start date
01/08/2010
Overall trial end date
29/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female primary care patients
2. Aged 18 and over
3. Either diagnosed as hypertensive or with mild to moderate depression (scoring 5-19 inclusive on PHQ-9)
4. Drinking alcohol over the UK recommended levels of 21 units per week for men or 14 units per week for women
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Under the age of 18
2. Cognitive impairment
3. Terminal illness
4. Severe depression or mental health problems
5. Accessing treatment for alcohol misuse
Recruitment start date
01/08/2010
Recruitment end date
29/02/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Health & Society
Newcastle Upon Tyne
NE2 4AX
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
North Tyneside NHS Primary Care Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24947447
Publication citations
-
Results
Wilson GB, Wray C, McGovern R, Newbury-Birch D, McColl E, Crosland A, Speed C, Cassidy P, Tomson D, Haining S, Howel D, Kaner EF, Intervention to reduce excessive alcohol consumption and improve comorbidity outcomes in hypertensive or depressed primary care patients: two parallel cluster randomized feasibility trials., Trials, 2014, 15, 235, doi: 10.1186/1745-6215-15-235.