Condition category
Circulatory System
Date applied
04/09/2009
Date assigned
15/10/2009
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zafar Iqbal

ORCID ID

Contact details

NHS Stoke on Trent
Heron House
120 Grove Road
Fenton
Stoke on Trent
ST4 4LX
United Kingdom
+44 (0)1782 298130
zafar.iqbal@stoke.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial of additional lifestyle support for the reduction of cardiovascular disease (CVD) risk through primary care in Stoke on Trent

Acronym

Study hypothesis

Additional lifestyle support will lead to an increased reduction in cardiovascular disease risk, as measured by the Framingham 10-year cardiovascular disease (CVD) risk estimate (systolic blood pressure version), compared with usual primary prevention care at 1 year. The study is powered (at 0.8) to detect an effect size of 0.3, assumes a cluster (general practice) effect (inter-cluster correlation coefficient) of .03 and that there will be 46 general practices in Stoke on Trent participating in the trial.

Ethics approval

South Birmingham Research Ethics Committee, 25/03/2009, ref: 09/H1207/17

Study design

Prospective open-label individually randomised controlled trial clustered by general practice

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

Cardiovascular disease prevention through primary care

Intervention

1,840 participants in total will be recruited from 46 general practices (20 treatment and 20 control patients per practice).

Lifestyle support (treatment): The intervention will be 20 weeks, thereafter patients will be able to continue with individual support provided every 3 months for up to 1 year (if required). NHS Stoke on Trent has established a new community-based primary prevention/health improvement programme (Lifestyle Support programme) that is being rolled out across the City during 2008/11. The Programme aims to identify and support people who are believed to be at high risk of developing cardiovascular disease and target those with diabetes and established heart disease. Those with an established cardiovascular risk >=20% identified by the practice's primary prevention component of the overall programme will be invited to meet with a lifestyle coach and be referred to free support for physical activity, weight and diet management, smoking cessation and motivational counselling as desired. Practices participating in the study will be supported by project support workers, working to the Primary Care Trust (PCT) protocol for the recruitment, allocation and treatment of patients.

Usual primary prevention care (control): Usual care allocated patients invited for screening will have their 10-year CVD risk calculated by an independent investigator to confirm eligibility for inclusion in the trial and will have undergone usual screening as part of the Practice's primary prevention programme (working to the agreed PCT protocol). These patients will receive usual care provided by the Practice (which may include treatment for blood pressure and/or cholesterol, smoking cessation, signposting to other services and/or lifestyle advice or intervention by the general practice team) but will not receive the additional external support for lifestyle change from the Lifestyle Support programme. These patients will be scheduled for a full repeat cardiovascular risk assessment at 1 year by the general practice team. After 1 year, these patients will be given opportunity to join the Lifestyle Support programme.

Staggered recruitment of general practices (from which individual patients will be randomised) will take place over 6 months. All patients will be followed up for 1 year after recruitment to the trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Framingham 10-year CVD risk at 1 year after starting on the programme. This endpoint was chosen because it represents an all-round measure of the intervention's ability to achieve its objectives of informed clinical decision making as well as educating and motivating patients to address (and sustain changes to) modifiable multiple CVD risk factors and lifestyle.

Secondary outcome measures

Secondary outcomes will be measured to better understand the specific mechanisms by which the intervention did or did not help to achieve the primary endpoint.

1. Sustained progress with these lifestyle changes will be assessed at 6 months and 1 year by the following:
1.1. Weight (objectively measured for calculation of body mass index [BMI]) and waist circumference
1.2. Health-related quality of life using the SF-12® Health Survey
1.3. Physical activity
2. Changes in the following at 1 year:
2.1. Total cholesterol, high density lipoprotein (HDL) cholesterol
2.2. Systolic and diastolic blood pressure
2.3. Smoking habits
2.4. Diabetes and CVD status
3. Adherence (self-reported) with:
3.1. Anti-hypertensive therapy
3.2. Lipid-lowering therapy
3.3. Weight loss therapy
3.4. Physical activity recommendations
4. Proportions of patients achieving the following targets at 1 year:
4.1. Blood pressure goals of <140/90 mmHg
4.2. Cholesterol goals of TC <=5.0 mmol/l and TC/HDL-C ratio <=4.5

Overall trial start date

01/09/2009

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Willingness to participate in either arm of the trial
2. Written informed consent
3. Aged between 35 and 74 years
4. Women highly unlikely to conceive over the course of the trial
5. Framingham 10-year CVD risk >=20%

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1,840

Participant exclusion criteria

1. Documented history of cardiovascular disease
2. Documented history of diabetes mellitus or fasting glucose >6.9 mmol/l at screening
3. Physical or mental incapacity to participate in the programme (if offered)
4. Participation in other studies
5. Research site personnel
6. Patients whose language skills would not enable them to participate in treatment programmes
7. In addition, the following contra-indications to the physical activity component will apply:
7.1. Resting systolic blood pressure >180 mmHg or resting diastolic blood pressure >100 mmHg
7.2. Febrile illness or acute infection
7.3. Neuromuscular or rheumatoid conditions that are exacerbated by exercise
7.4. Patients who have had a major operation or joint surgery within the previous three months or are scheduled to undergo a major operation or joint surgery within three months of the recruitment date

Recruitment start date

01/09/2009

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Stoke on Trent
Stoke on Trent
ST4 4LX
United Kingdom

Sponsor information

Organisation

NHS Stoke on Trent (UK)

Sponsor details

c/o Dr Giri Rajaratnam
Heron House
120 Grove Road
Fenton
Stoke on Trent
ST4 4LX
United Kingdom
+44 (0)1782 298145
giri.rajaratnam@stoke.nhs.uk

Sponsor type

Government

Website

http://www.stokepct.nhs.uk/

Funders

Funder type

Government

Funder name

NHS Stoke on Trent (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

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20430115

Publication citations

  1. Protocol

    Davey R, Cochrane T, Iqbal Z, Rajaratnam G, Chambers R, Mawby Y, Picariello L, Leese C, Ryder N, Randomised controlled trial of additional lifestyle support for the reduction of cardiovascular disease risk through primary care in Stoke-on-Trent, UK., Contemp Clin Trials, 2010, 31, 4, 345-354, doi: 10.1016/j.cct.2010.04.002.

Additional files

Editorial Notes