Condition category
Circulatory System
Date applied
29/08/2012
Date assigned
03/10/2012
Last edited
08/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.newcastle-hospitals.org.uk/

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

Publication citations

Additional files

Editorial Notes