Preventing disease through opportunistic, rapid engagement by primary care teams using behaviour change counselling
| ISRCTN | ISRCTN22495456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22495456 |
| Secondary identifying numbers | G0501283 |
- Submission date
- 08/06/2006
- Registration date
- 11/09/2006
- Last edited
- 22/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christopher Butler
Scientific
Scientific
Department of General Practice
Cardiff University
Centre for Health Sciences Research
School of Medicine
3rd Floor
Neuadd Merionnydd
Heath Park
Cardiff
CF14 4XN
United Kingdom
| butlercc@cf.ac.uk |
Study information
| Study design | Cluster randomised trial with randomisation at the level of general practice |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Preventing disease through opportunistic, Rapid EngagEMent by Primary care Teams using behaviour change counselling |
| Study acronym | PRE-EMPT |
| Study objectives | There are three main aims: 1. To determine whether exposing clinicians to blended learning of Behaviour Change Counselling (BCC) leads to patients making more positive changes regarding smoking, risky drinking, physical activity and unhealthy eating, and at what cost? 2. To examine if patients consulting with clinicians exposed to blended learning of Behaviour Change Counselling recall behavioural interventions more often and find them more acceptable and do they state that they intend to change more often? 3. To explore if clinicians exposed to blended learning of BCC feel more efficacious in advising on behaviour change, and committed to behaviour change counselling? |
| Ethics approval(s) | Multi-centre Research Ethics Committee (MREC) for Wales, 09/05/2007, ref: 07/MRE09/11 |
| Health condition(s) or problem(s) studied | Behaviour change counselling in patients with unhealthy lifestyles |
| Intervention | Clinicians in the experimental group will receive training in Behaviour Change Counselling, using a blended learning, multi-method approach including on-line learning and face to face seminar sessions. Clinicians will then use this when interacting with patients around health behaviour change. The comparison group will provide usual care with the offer of training after the study period. |
| Intervention type | Behavioural |
| Primary outcome measure | Proportion of patients showing important positive change in one or more of the four behaviours (smoking, alcohol use, exercise and healthy eating) at three months |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2006 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 practices (12 intervention; 12 control) |
| Key inclusion criteria | 1. Ability to provide informed consent 2. Aged 18 years and over 3. English speaking 4. Screening positive to any of the four behaviours (smoking, alcohol use, exercise and healthy eating) |
| Key exclusion criteria | 1. Serious acute illness 2. Terminal illness 3. Severe psychiatric illness (as indicated by health professional) |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff University
Cardiff
CF14 4XN
United Kingdom
CF14 4XN
United Kingdom
Sponsor information
Cardiff University (UK)
University/education
University/education
Research and Commercial Division
Cardiff University
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| DaviesKP2@cf.ac.uk | |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
National Prevention Research Initiative (NPRI) (UK) (ref: G0501283)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/09/2010 | Yes | No | |
| Results article | results | 19/03/2013 | Yes | No | |
| Results article | results | 09/10/2015 | Yes | No |
Editorial Notes
22/06/2016: Publication reference added.
15/07/2010: the overall trial end date was changed from 30/11/2009 to 31/12/2010.
