Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial

Abstract

Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies.Design Pragmatic, multicentre, randomised controlled trial.Setting 42 general practices in three areas of England.Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score.Interventions Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone.Main outcome measures The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked.Results 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic −2.7 mm Hg (95% confidence interval −4.7 to −0.6 mm Hg), mean diastolic −2.8 (−4.0 to −1.6 mm Hg); weight −1.0 kg (−1.8 to −0.3 kg), and body mass index −0.4 ( −0.6 to −0.1) but not cholesterol −0.1 (−0.2 to 0.0), smoking status (adjusted odds ratio 0.4, 0.2 to 1.0), or overall cardiovascular risk as a continuous measure (−0.4, −1.2 to 0.3)). The intervention was associated with improvements in diet, physical activity, drug adherence, and satisfaction with access to care, treatment received, and care coordination. One serious related adverse event occurred, when a participant was admitted to hospital with low blood pressure.Conclusions This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk, and there was no overall improvement in average risk. The Healthlines service was, however, associated with improvements in some risk behaviours, and in perceptions of support and access to care.Trial registration Current Controlled Trials ISRCTN 27508731.

Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial

“…The intervention was intended to promote behaviour change, optimisation of medication, improved coordination of care and improved medication adherence in patients with a high risk of developing CVD. Development of the intervention,9 the protocol for the trial10 and the main results of the trial have been published elsewhere 11…”

Providing heart failure rehabilitation in the home via telerehabilitation

“…These recommendations in combination with the motivating influences are consistent with the patient characteristics and effective chronic disease components of the TECH model. Some suggested strategies to maximise a successful telehealth implementation include facilitate confidence with technology, access fast reliable internet, adopt simple inexpensive technology, promote self-monitoring, encourage active participation and regularly review patient progress (Salisbury et al, 2015). Consistent with previous work (Hoaas et al, 2016;Kairy et al, 2013), most of our participants preferred to complement telerehabilitation with in-person visits.…”

“…Patient experience with technology and exercise were self-reported. Patient characteristics such as age and confidence with technology have been suggested to have an impact on how telehealth can affect outcomes (Salisbury et al, 2015). Participants were recruited concurrently with data analysis and recruitment continued until data saturation was reached.…”

“…The program is consistent with the TElehealth in CHronic disease (TECH) model (Salisbury et al, 2015), that includes a focus on patient and clinician engagement and effective chronic disease management for facilitating the best chance of success for telehealth interventions. For instance, we implemented engagement strategies through information booklets, demonstration sessions and introductory letters.…”

“…Quantitative: A survey was developed with seven open-ended questions identified from the literature (Salisbury et al, 2015;Steele et al, 2012), and from clinical and research experience.…”