Edo Richard1, Eric P Moll van Charante2, Marieke P Hoevenaar-Blom3, Nicola Coley4, Mariagnese Barbera5, Abraham van der Groep6, Yannick Meiller7, Francesca Mangialasche8, Cathrien B Beishuizen3, Susan Jongstra3, Tessa van Middelaar3, Lennard L Van Wanrooij3, Tiia Ngandu9, Juliette Guillemont10, Sandrine Andrieu4, Carol Brayne11, Miia Kivipelto12, Hilkka Soininen13, Willem A Van Gool3. 1. Department of Neurology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, Netherlands; Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, Netherlands. Electronic address: e.richard@amsterdamumc.nl. 2. Department of Primary Care, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, Netherlands. 3. Department of Neurology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, Netherlands. 4. INSERM, University of Toulouse UMR1027, Toulouse, France; Department of Epidemiology and Public Health, Toulouse University Hospital, Toulouse, France. 5. Institute of Clinical Medicine, Neurology, University of Eastern Finland, Kuopio, Finland. 6. Vital Health Software, Ede, Netherlands. 7. Department of Information and Operations Management, ESCP Europe, Paris, France. 8. Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet and Stockholm University, Stockholm, Sweden. 9. Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; Public Health Promotion Unit, National Institute for Health and Welfare, Helsinki, Finland. 10. INSERM, University of Toulouse UMR1027, Toulouse, France. 11. Department of Public Health and Primary Care, Cambridge Institute of Public Health, University of Cambridge, UK. 12. Institute of Clinical Medicine, Neurology, University of Eastern Finland, Kuopio, Finland; Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland; Division of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden; Neuroepidemiology and Aging Unit, School of Public Health, Imperial College London, UK. 13. Institute of Clinical Medicine, Neurology, University of Eastern Finland, Kuopio, Finland; Neurocenter, Neurology, Kuopio University Hospital, Kuopio, Finland.
Abstract
BACKGROUND: Although web-based interventions have been promoted for cardiovascular risk management over the past decade, there is limited evidence for effectiveness of these interventions in people older than 65 years. The healthy ageing through internet counselling in the elderly (HATICE) trial aimed to determine whether a coach-supported internet intervention for self-management can reduce cardiovascular risk in community-dwelling older people. METHODS: This prospective open-label, blinded endpoint clinical trial among people age 65 years or over at increased risk of cardiovascular disease randomly assigned participants in the Netherlands, Finland, and France to aninteractive internet intervention stimulating coach-supported self-management or a control platform. Primary outcome was the difference from baseline to 18 months on a standardised composite score (Z score) of systolic blood pressure, LDL cholesterol, and body-mass index (BMI). Secondary outcomes included individual risk factors and cardiovascular endpoints. This trial is registered with the ISRCTN registry, 48151589, and is closed to accrual. FINDINGS: Among 2724 participants, complete primary outcome data were available for 2398 (88%). After 18 months, the primary outcome improved in the intervention group versus the control group (0·09 vs 0·04, respectively; mean difference -0·05, 95% CI -0·08 to -0·01; p=0·008). For individual components of the primary outcome, mean differences (intervention vs control) were systolic blood pressure -1·79 mm Hg versus -0·67 mm Hg (-1·12, -2·51 to 0·27); BMI -0·23 kg/m2 versus -0·08 kg/m2 (-0·15, -0·28 to -0·01); and LDL -0·12mmol/L versus -0·07 mmol/L (-0·05, -0·11 to 0·01). Cardiovascular disease occurred in 30 (2·2%) of 1382 patients in the intervention versus 32 (2·4%) of 1333 patients in the control group (hazard ratio 0·86, 95% CI 0·52 to 1·43). INTERPRETATION: Coach-supported self-management of cardiovascular risk factors using an interactive internet intervention is feasible in an older population, and leads to a modest improvement of cardiovascular risk profile. When implemented on a large scale this could potentially reduce the burden of cardiovascular disease. FUNDING: European Commission Seventh Framework Programme.
RCT Entities:
BACKGROUND: Although web-based interventions have been promoted for cardiovascular risk management over the past decade, there is limited evidence for effectiveness of these interventions in people older than 65 years. The healthy ageing through internet counselling in the elderly (HATICE) trial aimed to determine whether a coach-supported internet intervention for self-management can reduce cardiovascular risk in community-dwelling older people. METHODS: This prospective open-label, blinded endpoint clinical trial among people age 65 years or over at increased risk of cardiovascular disease randomly assigned participants in the Netherlands, Finland, and France to an interactive internet intervention stimulating coach-supported self-management or a control platform. Primary outcome was the difference from baseline to 18 months on a standardised composite score (Z score) of systolic blood pressure, LDL cholesterol, and body-mass index (BMI). Secondary outcomes included individual risk factors and cardiovascular endpoints. This trial is registered with the ISRCTN registry, 48151589, and is closed to accrual. FINDINGS: Among 2724 participants, complete primary outcome data were available for 2398 (88%). After 18 months, the primary outcome improved in the intervention group versus the control group (0·09 vs 0·04, respectively; mean difference -0·05, 95% CI -0·08 to -0·01; p=0·008). For individual components of the primary outcome, mean differences (intervention vs control) were systolic blood pressure -1·79 mm Hg versus -0·67 mm Hg (-1·12, -2·51 to 0·27); BMI -0·23 kg/m2 versus -0·08 kg/m2 (-0·15, -0·28 to -0·01); and LDL -0·12 mmol/L versus -0·07 mmol/L (-0·05, -0·11 to 0·01). Cardiovascular disease occurred in 30 (2·2%) of 1382 patients in the intervention versus 32 (2·4%) of 1333 patients in the control group (hazard ratio 0·86, 95% CI 0·52 to 1·43). INTERPRETATION: Coach-supported self-management of cardiovascular risk factors using an interactive internet intervention is feasible in an older population, and leads to a modest improvement of cardiovascular risk profile. When implemented on a large scale this could potentially reduce the burden of cardiovascular disease. FUNDING: European Commission Seventh Framework Programme.
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