Chris Salisbury|Alicia O’Cathain|Clare Thomas|Louisa Edwards|Daisy Gaunt|Padraig Dixon|Sandra Hollinghurst|Jon Nicholl|Shirley Large|Lucy Yardley|Tom Fahey|Alexis Foster|Katy Garner|Kimberley Horspool|Mei?See Man|Anne Rogers|Catherine Pope|Alan Montgomery
Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial
University of Bristol|University of Sheffield|University of Bristol|University of Bristol|University of Bristol|University of Bristol|University of Bristol|University of Sheffield|University of Southampton|Royal College of Surgeons in Ireland|University of Sheffield|University of Bristol|University of Sheffield|University of Bristol|University of Southampton|University of Southampton|Queen's Medical Centre
bobjectivebnbspto assess whether nonclinical staff effectively manage people high risk cardiovascular disease using digital health technologies bdesignbnbsppragmatic multicentre randomised controlled trial bsettingbnbsp42 general practices three areas england bparticipantsbnbspbetween 3 december 2012 23 july 2013 recruited 641 adults aged 40 74 years 10 year cardiovascular disease risk 20 previous cardiovascular event least one modifiable risk factor systolic blood pressure 140 mm hg body mass index 30 current smoker access telephone internet email participants individually allocated intervention n325 control n316 groups using automated randomisation stratified site minimised practice baseline risk score binterventionsbnbspintervention healthlines service alongside usual care comprising regular telephone calls trained lay health advisors following scripts generated interactive software advisors facilitated self management supporting participants use online resources reduce risk factors sought optimise drug use improve treatment adherence encourage healthier lifestyles control group comprised usual care alone bmain outcome measuresbnbspthe primary outcome proportion participants responding treatment defined maintaining reducing cardiovascular risk 12 months outcomes collected six 12 months randomisation analysed masked participants masked bresultsbnbsp50 148295 participants intervention group responded treatment compared 43 124291 control group adjusted odds ratio 13 95 confidence interval 10 19 number needed treat13 difference possibly due chance p008 intervention associated reductions blood pressure difference mean systolic 27 mm hg 95 confidence interval 47 06 mm hg mean diastolic 28 40 16 mm hg weight 10 kg 18 03 kg body mass index 04 06 01 cholesterol 01 02 00 smoking status adjusted odds ratio 04 02 10 overall cardiovascular risk continuous measure 04 12 03 intervention associated improvements diet physical activity drug adherence satisfaction access care treatment received care coordination one serious related adverse event occurred participant admitted hospital low blood pressure bconclusionsbnbspthis evidence based telehealth approach associated small clinical benefits minority people high cardiovascular risk overall improvement average risk healthlines service however associated improvements risk behaviours perceptions support access care btrial registrationbnbspcurrent controlled trials isrctn 27508731