Pooled net change in systolic blood pressure ( 16 trials ) was -1.86 ( 95 % CI -3.17 to -0.55 ; p=0.01 ) mm Hg ; diastolic blood pressure ( 15 trials ) , -1.53 ( -2.43 to -0.62 ; p=0.001 ) mm Hg ; body mass index ( 14 trials ) , -0.13 ( -0.26 to -0.01 ; p=0.04 ) kg/m2 ; serum total cholesterol ( 14 trials ) , -0.13 ( -0.19 to -0.07 ; p<0.001 ) mmol/L. There was no significant association between interventions with a reported theoretical basis and improved intervention outcomes .
No association was observed between intervention intensity ( number of sessions and intervention duration ) and intervention outcomes .
MHBC interventions delivered to CVD-free participants in primary care did not appear to have quantitatively important effects on CVD risk factors .
BACKGROUND It is uncertain whether multiple health behaviour change ( MHBC ) interventions are effective for the primary prevention of cardiovascular disease ( CVD ) in primary care .
Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial
Objective To assess whether non- clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies . Design Pragmatic , multicentre , r and omised controlled trial . Setting 42 general practice s in three areas of Engl and . 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 r and omisation 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 re sources 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 r and omisation 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 IS RCT N 27508731
Pooled net change in systolic blood pressure ( 16 trials ) was -1.86 ( 95 % CI -3.17 to -0.55 ; p=0.01 ) mm Hg ; diastolic blood pressure ( 15 trials ) , -1.53 ( -2.43 to -0.62 ; p=0.001 ) mm Hg ; body mass index ( 14 trials ) , -0.13 ( -0.26 to -0.01 ; p=0.04 ) kg/m2 ; serum total cholesterol ( 14 trials ) , -0.13 ( -0.19 to -0.07 ; p<0.001 ) mmol/L. There was no significant association between interventions with a reported theoretical basis and improved intervention outcomes .
No association was observed between intervention intensity ( number of sessions and intervention duration ) and intervention outcomes .
MHBC interventions delivered to CVD-free participants in primary care did not appear to have quantitatively important effects on CVD risk factors .
BACKGROUND It is uncertain whether multiple health behaviour change ( MHBC ) interventions are effective for the primary prevention of cardiovascular disease ( CVD ) in primary care .