Plain English Summary
Background and study aims:
Research has demonstrated that physical activity has a clear protective effect on cardiovascular disease (CVD). What is not well understood is how best to support people who are at increased risk of cardiovascular disease to become more physically active and maintain this over time. This study aims to find out whether the use of structured support provided by healthcare professionals in primary care is feasible, acceptable and effective for increasing levels of physical activity in patients with increased risk of CVD.
Who can participate?
All primary care organisations within County Durham and Darlington will be invited to take part in the study. Patients aged 18 years or over who have been identified as at increased risk of cardiovascular disease or as 'inactive' or 'moderately inactive' in a recent NHS Health Check.
What does the study involve?
All primary care organisations in the County Durham and Darlington region will be invited to take part in the study. Healthcare professionals will be given access to the online intervention which comprises 11 distinct yet inter-related modules on topics such as physical activity and sedentary behaviour in relation to CVD, and the processes involved in behaviour change. The course aims to equip healthcare professionals working in primary care with knowledge and skills to deliver a behavioural intervention designed to increase levels of physical activity of their patients. Patients will have three conversations (one face-to-face and two via telephone) of up to 30 minutes each with their healthcare professional at the start of the study (baseline), and after 2 and 4 months. They will also be provided with access to an online behaviour change 'toolkit'. This website provides them with information on physical activity, but also tools for them to set physical activity goals, plans and monitor their progress.
What are the possible benefits and risks of participating?
The time taken for the healthcare professionals to complete the online intervention, the survey questionnaires and participate in interviews as well as delivering the intervention could be considered burdensome. However, the knowledge and skills potentially gained following successful completion of the intervention are considered to outweigh the burden of taking part. Additionally, professionals will receive CPD credit for completing the intervention. The time taken for the patients to have additional consultations with their healthcare professional, complete paper-based survey questionnaires and wear an accelerometer for 7 days during each data collection time point (baseline, 3 and 6 months) may be considered burdensome. However, the potential benefits the patients may experience if they increase their physical activity are anticipated to outweigh the burden of taking part and any inconvenience encountered.
Where is the study run from?
The study is run by Newcastle University; however, it will be carried out in primary care organisations across the County Durham and Darlington region.
When is the study starting and how long is it expected to run for?
The study is due to start June 2014 and run for 12 months in total. The last patient will be recruited 6 months after the study starts.
Who is funding the study?
The study is funded by County Durham Sport.
Who is the main contact?
Dr Mike Trenell
michael.trenell@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Michael Trenell
ORCID ID
Contact details
Newcastle University
Faculty of Medical Sciences
William Leech Building
Institute of Cellular Medicine
Newcastle Upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 222 6935
michael.trenell@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Feasibility, acceptability and effectiveness of a multi-faceted behavioural intervention targeting levels of physical activity in adults at increased risk of cardiovascular disease in primary care: movement as medicine for cardiovascular disease prevention
Acronym
Study hypothesis
A theory-based behavioural intervention will be more effective than standard clinical care for impacting positively on levels of free living physical activity on risks of developing cardiovascular disease.
On 27/05/2014 the following changes were made to the trial record:
1. The study design was changed from 'Single centre clustered randomised controlled with parallel groups' to 'One-group exploratory trial'.
2. The target number of participants was changed from 400 to 200.
3. The overall trial start date was changed from 31/01/2013 to 01/06/2014.
4. The overall trial end date was changed from 30/01/2015 to 01/06/2015.
Ethics approval
NRES Committee North East - Newcastle & North Tyneside 1, 25/03/2014, 14/NE/0062
Study design
One-group exploratory trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Increased risk of cardiovascular disease
Intervention
Current interventions as of 27/05/2014:
A theory-based accredited online training programme for primary care practitioners. An online toolkit consisting of physical activity promotion materials, activity planners and trackers and a pedometer for patients. Patients will have three conversations (one face-to-face and two via telephone) of up to 30 minutes each with their healthcare professional at baseline, 2 and 4 months.
Previous interventions:
A theory based accredited online training programme for primary care practitioners and a toolkit physical activity promotion materials, activity planners and trackers and a pedometer.
Intervention group: Patients will attend face to face review appointments over a 12-month period (baseline, 1, 6 and 12 months) where they will be supported using the toolkit to increase their levels of physical activity.
Control group: Standard clinical care.
Both the intervention and control group will receive a telephone call at 3 months.
The previous sponsor for this trial (up to 27/05/2014) was:
NHS County Durham and Darlington (UK)
c/o Richard Errington
John Snow House
Durham University Science Park
County Durham
DH1 3YG
United Kingdom
+44 (0)191 374 4211
richard.errington@nhs.net
http://www.countydurham.nhs.uk/
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Current primary outcome measures as of 27/05/2014:
Primary care practitioners:
Use of behaviour change techniques and counselling skills
Patients:
Engagement in the programme
Previous primary outcome measures:
Primary care practitioners:
Use of behaviour change techniques and counselling skills
Patients:
Objectively and subjectively assessed physical activity behaviour
Secondary outcome measures
Current secondary outcome measures as of 27/05/2014:
Primary care practitioners:
1. Cardiovascular disease and physical activity-related knowledge and attitudes/beliefs
2. Self-efficacy for delivering physical activity-related counselling to adults at increased cardiovascular disease risk
3. Use of online course materials
Patients:
1. Theoretical predictors of physical activity
2. Sedentary behaviour patterns
3. Use and evaluation of intervention materials
Previous secondary outcome measures:
Primary care practitioners:
1. Cardiovascular disease and physical activity-related knowledge and attitudes/beliefs
2. Self efficacy for delivering physical activity-related counseling to adults at increased cardiovascular disease risk
Patients:
1. Cholesterol
2. Blood pressure
3. Body mass index (BMI) and waist circumference
4. Cardiovascular disease and physical activity related knowledge and attitudes / beliefs
5. Physical activity related self efficacy
6. Health-related quality of life
7. Sedentary behaviour patterns
8. Achievement of physical activity goals
Overall trial start date
01/06/2014
Overall trial end date
01/06/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 27/05/2014:
1. Age between 18-75 years
2. Have the capacity to provide informed written consent
3. Able to read, speak and understand English without the support of an interpreter
4. Have access to the internet and therefore all intervention materials
5. Deemed fit to partake in physical activity/exercise by the Physical Activity Readiness Questionnaire (PAR-Q)
6. Have been identified as physically inactive with the General Practice Physical Activity Questionnaire (GPPAQ) during an NHS Health Check OR identified as having at least a 20% risk of CVD in the next 10 years
Previous inclusion criteria:
1. Adults aged ≥18 years
2. Identified to be at increased cardiovascular disease risk
3. Physical activity/ exercise is below recommendations (i.e. 30 minutes per day three times per week)
4. Capacity to provide informed consent
5. Ability to write and converse in English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Contra-indications to performing physical activity
Recruitment start date
01/06/2014
Recruitment end date
01/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
c/o Susan Ridge
Newcastle Joint Research Office (Research & Development)
Level 6
Leazes Wing
Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom
+ 44 (0)191 282 4823
susan.ridge@nuth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Current sources of funding as of 27/05/2014:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
County Durham Sport (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Previous sources of funding:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
County Durham and Darlington 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
Results - basic reporting
Publication summary