The effectiveness and cost-effectiveness of telehealth for reducing cardiovascular risk in patients at high risk: randomised controlled trial
There is international interest in the potential of telehealth to support people with long-term health conditions, although evidence of benefits from telehealth is inconsistent and evidence about cost-effectiveness is minimal. We developed a theory-based intervention, Healthlines, and evaluated it through pragmatic randomised controlled trials in two common exemplar conditions, one of which was raised cardiovascular disease (CVD) risk due to combined effects of hypertension, obesity, smoking and/or hyperlipidaemia.Healthlines was based on Health Information Advisors providing monthly telephone support to use a range of online resources to promote self-management over 12 months. The telephone support was based on a successful behavioural programme developed in the USA. Online resources included blood pressure self-monitoring with web-based patient feedback. The advisors regularly reviewed progress and addressed medication adherence, aiming to escalate treatment when necessary using protocols. Unlike most telehealth trials which examine discrete technological interventions, the Healthlines trials evaluate a comprehensive care programme based on telehealth which was designed to support (rather than compete with) primary care.
Eligible patients were aged 40-74 years, with a 10-year risk of a CVD event ?20% calculated using QRISK2, with one or more modifiable risk factors (BP ? 140, BMI ? 30, smoking). Patients were recruited via 42 general practices in England. Participants were individually randomised to the Healthlines Service or usual care. The primary outcome was maintenance or reduction of QRISK2 after 12 months. Secondary outcomes included individual risk factors, quality of life (EQ5D), self-management skills (HeiQ) and patient access to health care. Economic analysis explored cost-effectiveness.
641 patients were recruited and randomised (325 intervention; 316 control). 91% (586/641) provided primary outcome data. Participants had a mean (SD) age of 67 (5) years and 80% (n=515) were male. Mean (SD) baseline characteristics: QRISK2 score 31 (10), Body Mass Index 31 (6), blood pressure 148/81 (SD 17/10) mmHg, 17% (109/641) smokers.More participants in the intervention group (50% (148/295)) maintained or reduced their QRISK2 score at 12 months than in the control group (43% (124/291)), although the data do not exclude a null effect: odds ratio 1.3 (95%CI 1.0,1.8, p=0.08). The intervention was associated with small improvements in BMI (-0.4 (95%CI -0.6,-0.1), systolic (-2.7mmHg (95% CI -4.7,-0.6) and diastolic (-2.8mmHg (95% CI -4.0,-1.6) blood pressure, but not in smoking status (OR 1.7 (95% CI 0.8,3.3). Data on secondary outcomes and cost-effectiveness will be presented.
The intervention was associated with small improvements in some CVD risk factors, but these were associated with a non-significant overall benefit in 10-year risk of a CVD event. However, even small improvements in CVD risk could be cost-effective because of the health consequences and high cost of incurring a stroke so this will be an important issue.
- Chris Salisbury, Medical Care Research Unit, School of Health and Related Research
- Clare Thomas, Medical Care Research Unit, School of Health and Related Research
- Louisa Edwards, Medical Care Research Unit, School of Health and Related Research
- Kimberley Horspool, Bristol Randomised Controlled Trials Collaboration, Bristol, UK
- Alexis Foster, Bristol Randomised Controlled Trials Collaboration, Bristol, UK
- Daisy Gaunt, NHS Direct, Hedge End, UK
- Padraig Dixon, NHS Direct, Hedge End, UK
- Sandra Hollinghurst, Medical Care Research Unit, School of Health and Related Research
- Shirley Large, Nottingham Health Science Partners, Nottingham Clinical Trials Unit, Nottingham, UK
- Jon Nicholl, Bristol Randomised Controlled Trials Collaboration, Bristol, UK
- Alicia O'Cathain, Bristol Randomised Controlled Trials Collaboration, Bristol, UK
- Alan Montgomery