Cardiovascular disease (CVD) Circulatory System Cardiovascular disease, unspecified
Conditions
Interventions
Current interventions as of 26/04/2013:
Telephone and internet-based intervention delivered by NHS Direct, involving regular contact to provide advice and encouragement by phone and access to tailored
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 26/04/2013: 1. QRisk2 score measured at 12 months 2. (Sub-study only) The number of patients consenting to participate in the Healthlines Trials Previous primary outcome measures until 26/04/2013: QRisk2 score measured at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/04/2013: 1. QRISK2 as a continuous variable 2. Quality of life (EQ-5D-5L) 3. Patient satisfaction 4. Patient perceived access to care 5. Exercise behaviour 6. Cardiovascular risk factors (BP, cholesterol, smoking status, weight, BMI, diet) 7. Use of telehealth interventions 8. Self management skills 9. Self efficacy 10. Medication adherence 11. Health literacy 12. Care coordination 13. (Sub-study only) Retention in the Healthlines studies. We will keep a record of all patients who were identified as potential participants and which intervention group they were in. Previous secondary outcome measures until 26/04/2013: 1. QRISK2 as a continuous variable 2. Quality of life (EQ-5D-5L) 3. Patient satisfaction 4. Patient perceived access to care 5. Exercise behaviour 6. Cardiovascular risk factors (BP, cholesterol, smoking status, weight, BMI, diet) 7. Use of telehealth interventions 8. Self management skills 9. Self efficacy 10. Medication adherence 11. Health literacy 12. Care coordination | — |
Countries
United Kingdom
Outcome results
None listed