Healthlines randomised controlled trial - cardiovascular disease risk

Not Applicable

Completed

• Conditions: Cardiovascular disease (CVD); Circulatory System; Cardiovascular disease, unspecified

• Registration Number: ISRCTN27508731
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24460845 2015 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/26187378 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26044763 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27252245 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27670521 2016 cost-effectiveness results inhttps://www.ncbi.nlm.nih.gov/pubmed/27566642

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-05
• Study Completion: 2013-07-31
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

Current inclusion criteria as of 26/04/2013:
1. Access to a telephone (landline or mobile), the Internet and an e-mail address for personal use.
2. Aged between 40 - 74 years (on date of invitation to participate)
3. 10-year risk of cardiovascular event of =20% calculated using QRISK2
4. At least one of the following modifiable risk factors:
4.1. Current systolic blood pressure > or = 140mmHg
4.2. BMI > or = 30
4.3. Current smoker
5. Male or female

Previous inclusion criteria until 26/04/2013:
1. Access to a telephone (landline or mobile), the Internet and an e-mail address for personal use.
2. Aged between 40 - 74 years (on date of invitation to participate)
3. 10-year risk of cardiovascular event of =20% calculated using QRISK2
4. At least one of the following modifiable risk factors:
4.1. Previous GP recorded diagnosis of hypertension
4.2. Current systolic blood pressure = 140mmHg; BMI = 30
4.3. Current smoker
5. Male or female

Exclusion Criteria

1. Established diagnosis of cardiovascular disease, defined as history of heart attack, angina, heart failure, stroke or transient ischaemic attack.
2. Currently pregnant or planning to become pregnant within the next 12 months
3. Patients eligible for the NHS Health Checks Programme during the period of the trial (where local PCTs request this)
4. Bipolar disorder
5. Psychotic illness
6. Dementia or substantial cognitive impairmet
7. Severe learning disability
8. Substance dependenc
9. Receiving palliative car
10. Significant suicidal riks
11. GP determines that participation would cause distress (e.g. due to recent bereavement)
12. Inability to communicate verbally in English sufficiently to receive telephone-based support delivered in English. Patients who can communicate verbally in English but are unable to read English will be eligible provided they have a family member or friend who is willing and able to translate written materials (such as information sheets, consent forms and online material) for them.

Study & Design

• Study Type: Interventional
• Study Design: Not specified