Final Report Summary - HATICE (Healthy Aging Through Internet Counselling in the Elderly)
Executive Summary:
Background and aim
People over 65 with multiple cardiovascular risk factors or manifest cardiovascular disease are at increased risk of poor clinical outcome: myocardial infarction, stroke, dementia and death. Insufficient adherence to effective and evidence-based interventions plays an important role in suboptimal prevention. Improved patient engagement has great potential to improve management of individuals at risk.
The overall aim of HATICE was to develop a comprehensive, innovative internet-based interactive intervention strategy for optimisation of management of older people with multiple cardiovascular risk factors or cardiovascular disease. This widely applicable and generic intervention strategy was immediately put to the test in an investigator-initiated randomised controlled trial.
Results and impacts
Shared data platform
- The data of the preDIVA trial, FINGER trial and MAPT trial have been pooled in the shared data platform developed within HATICE. The pooled data have been used for identification of characteristics that either impede or stimulate optimal management of multiple cardiovascular diseases or risk factors, specifically in older persons, which was highly valuable to optimize the HATICE intervention and will be useful for future intervention studies in this area. Additional, pooled analyses on the effect of the three interventions on cognition and cardiovascular risk factors are ongoing.
- The data sharing platform is generic and can be applied to other studies.
Intervention platform for the randomised controlled trial
- The developed HATICE interactive internet intervention platform is a web-based, cloud deployment solution with minimal total cost of ownership and is easily adaptable for use in other EU member states and their health-care systems. It allows for tailor-made interventions specifically suited to the needs of older persons and will engage and thus empower older persons by shifting the locus of control from traditional health care providers to the elderly themselves. An ongoing example is that HATICE will form the basis of a mHealth intervention in older people with low socioeconomic status SES in the UK and in China (PRODEMOS, H2020, grant agreement no 779238).
- The internet-based intervention strategy is expected to reduce new cardiovascular events and possibly also dementia in older populations in the long term. This is expected to result in a substantial lowering of healthcare costs. Because of the high costs that are associated with stroke, myocardial infarction and cognitive impairment it is highly likely that any risk reduction will eventually lead to lower healthcare costs. But also short term reductions of health care costs can be achieved because the internet platform itself can reduce the need for scheduled office consultations.
Trial results
- Knowledge on the results of the randomised trial on the effects of the interactive internet intervention stimulating coach-supported self-management will enable health policy stakeholders throughout the EU to optimize national prevention programs. Furthermore, our results contribute the design of evidence based interventions.
- The manuscript with the trial results has been drafted and is submitted to a high impact journal for peer review. The analyses of the cost effectiveness analyses are currently being performed.
Project Context and Objectives:
People over 65 with multiple cardiovascular risk factors or manifest cardiovascular disease are at increased risk of poor clinical outcome: myocardial infarction, stroke, dementia and death. Improved patient engagement has great potential to improve management of individuals at risk since insufficient adherence to effective and evidence-based interventions plays an important role in suboptimal prevention. Current knowledge on treatment of cardiovascular risk factors mostly comes from trials targeting one specific factor only, e.g. blood pressure, cholesterol or blood glucose levels, studied in a specific research setting. Little was known about the effect of multi-component interventions in a ‘real world’ setting. Presence of several vascular risk factors can lead to a cumulative increased risk and an intervention simultaneously aimed at multiple risk factors is therefore a potentially powerful tool. The European Dementia Prevention Initiative (EDPI,www.edpi.org) was launched by some of the HATICE partners prior to the start of HATICE. Participants in EDPI are all performing investigator-initiated RCTs evaluating whether a multi-component intervention aimed at vascular and life-style related risk factors can decrease the risk of cognitive decline, dementia and cardiovascular disease. Data sharing and pooled analyses of three recently completed RCTs guaranteed optimal use of the existing infrastructure.
The overall aim of HATICE was to develop a comprehensive, innovative internet-based interactive intervention strategy for optimisation of management of elderly with multiple cardiovascular risk factors or cardiovascular disease. In HATICE, this widely applicable and generic intervention strategy was immediately put to the test in an investigator-initiated randomised controlled trial.
Project Results:
Shared data platform
A platform to share data was developed within the HATICE project. This platform provides a way for HATICE partners to share data from the three recently completed RCTs, in order to carry out separate and pooled data analysis. In the platform raw data can be uploaded, which is then automatically recoded to uniform encodings between the studies. Subsequently the recoded datasets can be merged. Also the data of the HATICE trial will soon be shared via the shared data platform. Only HATICE partners have access to the shared data platform.
Data pooled data set
Individual participant data were pooled from three recently completed RCTs with a total of 6435 participants. These were the following multi-domain interventions: the Prevention of dementia by intensive vascular care trial (preDIVA, ISRCTN 29711771)(1), the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability trial (FINGER, NCT 01041989)(2) and the ‘Multidomain Alzheimer Preventive Trial (MAPT, NCT 00672685)’ (3). The intervention was operationalized differently in the three trials, but all targeted vascular risk factors aiming to prevent cognitive decline and /or dementia. The pooled dataset consisted of 172 variables, of which 101 were present in the original FINGER database, 105 in MAPT and 91 in preDIVA.
Internet intervention platform
An interactive Internet intervention platform was designed for older people.(4) The development of the platform followed five phases: (1) conceptual framework; (2) platform concept and functional design; (3) platform building (software and content); (4) testing and pilot study; and (5) final product. We performed a meta-analysis, reviewed guidelines for cardiovascular diseases, and consulted end users, experts, and software developers to create the platform concept and content. The software was built in iterative cycles. In the pilot study, 41 people aged approximately 65 years used the platform for 8 weeks. Participants used the interactive features of the platform and appreciated the coach support. During all phases adjustments were made to incorporate all improvements from the previous phases. The final platform is a personal, secured, and interactive platform supported by a coach.
Data intervention trial
A myriad of data has been collected during 18 months of follow up in the 2724 HATICE participants. Not only the BMI, systolic blood pressure and LDL cholesterol for the primary outcome, but also for the secondary outcomes: an extensive cognitive test battery, information on depression (GDS) and anxiety (HADS), diet (MEDAS), disability and functioning with the late life function and disability instrument (LLFDI), self-efficacy with the Partners in Health questionnaire (PIH), physical activity with the community health activities model program for seniors questionnaire (CHAMPS), and quality of life with the EuroQol (EQ5D) and blood was drawn for assessment of lipids, glucose, glycosylated haemoglobin (HbA1c) and c-reactive protein. The effect of the intervention on all of these outcomes has been analyzed and a manuscript has been drafted and submitted to a high impact international peer reviewed journal.
1. Moll van Charante, E.P. et al., Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. The Lancet, 2016. 388(10046): p. 797-805.
2. Ngandu, T., et al., A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. The Lancet, 2015. 385(9984): p. 2255-2263.
3. Andrieu, S., et al., Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol, 2017. 16(5): p. 377-389.
4. Jongstra S, Beishuizen C, Andrieu S, Barbera M, van Dorp M, van de Groep B, Guillemont J, Mangialasche F, van Middelaar T, Moll van Charante P, Soininen H, Kivipelto M, Richard E. Development and Validation of an Interactive Internet Platform for Older People: The Healthy Ageing Through Internet Counselling in the Elderly Study. Telemed J E Health. 2017 Feb;23(2):96-104. doi: 10.1089/tmj.2016.0066. Epub 2016 Jul 27.
Potential Impact:
Potential impact
Shared data platform
- The data of the preDIVA trial, FINGER trial and MAPT trial have been pooled in the shared data platform developed within HATICE. The pooled data have been used for identification of characteristics that either impede or stimulate optimal management of multiple cardiovascular diseases or risk factors and will be used for many more pooled analyses like the ongoing analyses on the effect of the three interventions on cognition and cardiovascular risk factors making specific subgroup analyses possible that would not be achievable based on the data of the individual studies due to the sample size. Thereby the data in the platform is used trial development as well as to scientific advances.
- The data sharing platform is generic and can be used to pool many other studies
Intervention platform for the randomised controlled trial
- The developed HATICE interactive internet intervention with minimal total cost of ownership is easily adaptable for use in other EU member states and their health-care systems. It allows for tailor-made interventions specifically suited to the needs of older persons and will engage and thus empower older persons by shifting the locus of control from traditional health care providers to the elderly themselves.
- The developed HATICE interactive internet intervention platform lays the foundation for future (international) prevention or treatment strategies. An ongoing example is that HATICE will form the basis of a mHealth intervention in older people with low SES in the UK and in China (PRODEMOS, H2020, grant agreement no 779238).
- If implemented, the internet-based intervention strategy is expected to reduce new cardiovascular events and possibly also dementia in the elderly population in the long term. Because of the high costs that are associated with stroke, myocardial infarction and cognitive impairment it is highly likely that any risk reduction will eventually lead to lowering of healthcare costs. But also short term reductions of health care costs can be achieved because the internet platform itself can reduce the need for scheduled office consultations.
Trial results
- Knowledge on the specific results of the randomised trial on the effects of the interactive internet intervention stimulating coach-supported self-management will enable health policy stakeholders throughout the EU to optimize national prevention programs. Furthermore, our results contribute the design of evidence based interventions.
- The manuscript of the trial results has been drafted and is submitted to a high impact peer reviewed journal. The cost effectiveness analyses are currently being performed.
Dissemination activities
In total, 15 manuscripts were published in peer reviewed international papers by the HATICE consortium and many manuscripts are in the pipeline. Furthermore, there were the following dissemination activities:
- 89 oral presentations to a scientific event and 57 to a wider public
- 39 posters were presented at a scientific event
- 4 articles published in the popular press
- 5 interviews, 2 videos, and 6 tv clips
- 2 media briefings and 2 press releases
All dissemination activities are shown in the table A1.
Exploitation of the results
The knowledge acquired in the HATICE project as well as the internet intervention platform will be used as the basis for the development of a mHealth intervention in older people with low SES in the UK and in China (PRODEMOS, H2020, grant agreement no 779238).
List of Websites:
Public website address: http://www.hatice.eu/
Contact via the contact form on the website: http://www.hatice.eu/contact
Background and aim
People over 65 with multiple cardiovascular risk factors or manifest cardiovascular disease are at increased risk of poor clinical outcome: myocardial infarction, stroke, dementia and death. Insufficient adherence to effective and evidence-based interventions plays an important role in suboptimal prevention. Improved patient engagement has great potential to improve management of individuals at risk.
The overall aim of HATICE was to develop a comprehensive, innovative internet-based interactive intervention strategy for optimisation of management of older people with multiple cardiovascular risk factors or cardiovascular disease. This widely applicable and generic intervention strategy was immediately put to the test in an investigator-initiated randomised controlled trial.
Results and impacts
Shared data platform
- The data of the preDIVA trial, FINGER trial and MAPT trial have been pooled in the shared data platform developed within HATICE. The pooled data have been used for identification of characteristics that either impede or stimulate optimal management of multiple cardiovascular diseases or risk factors, specifically in older persons, which was highly valuable to optimize the HATICE intervention and will be useful for future intervention studies in this area. Additional, pooled analyses on the effect of the three interventions on cognition and cardiovascular risk factors are ongoing.
- The data sharing platform is generic and can be applied to other studies.
Intervention platform for the randomised controlled trial
- The developed HATICE interactive internet intervention platform is a web-based, cloud deployment solution with minimal total cost of ownership and is easily adaptable for use in other EU member states and their health-care systems. It allows for tailor-made interventions specifically suited to the needs of older persons and will engage and thus empower older persons by shifting the locus of control from traditional health care providers to the elderly themselves. An ongoing example is that HATICE will form the basis of a mHealth intervention in older people with low socioeconomic status SES in the UK and in China (PRODEMOS, H2020, grant agreement no 779238).
- The internet-based intervention strategy is expected to reduce new cardiovascular events and possibly also dementia in older populations in the long term. This is expected to result in a substantial lowering of healthcare costs. Because of the high costs that are associated with stroke, myocardial infarction and cognitive impairment it is highly likely that any risk reduction will eventually lead to lower healthcare costs. But also short term reductions of health care costs can be achieved because the internet platform itself can reduce the need for scheduled office consultations.
Trial results
- Knowledge on the results of the randomised trial on the effects of the interactive internet intervention stimulating coach-supported self-management will enable health policy stakeholders throughout the EU to optimize national prevention programs. Furthermore, our results contribute the design of evidence based interventions.
- The manuscript with the trial results has been drafted and is submitted to a high impact journal for peer review. The analyses of the cost effectiveness analyses are currently being performed.
Project Context and Objectives:
People over 65 with multiple cardiovascular risk factors or manifest cardiovascular disease are at increased risk of poor clinical outcome: myocardial infarction, stroke, dementia and death. Improved patient engagement has great potential to improve management of individuals at risk since insufficient adherence to effective and evidence-based interventions plays an important role in suboptimal prevention. Current knowledge on treatment of cardiovascular risk factors mostly comes from trials targeting one specific factor only, e.g. blood pressure, cholesterol or blood glucose levels, studied in a specific research setting. Little was known about the effect of multi-component interventions in a ‘real world’ setting. Presence of several vascular risk factors can lead to a cumulative increased risk and an intervention simultaneously aimed at multiple risk factors is therefore a potentially powerful tool. The European Dementia Prevention Initiative (EDPI,www.edpi.org) was launched by some of the HATICE partners prior to the start of HATICE. Participants in EDPI are all performing investigator-initiated RCTs evaluating whether a multi-component intervention aimed at vascular and life-style related risk factors can decrease the risk of cognitive decline, dementia and cardiovascular disease. Data sharing and pooled analyses of three recently completed RCTs guaranteed optimal use of the existing infrastructure.
The overall aim of HATICE was to develop a comprehensive, innovative internet-based interactive intervention strategy for optimisation of management of elderly with multiple cardiovascular risk factors or cardiovascular disease. In HATICE, this widely applicable and generic intervention strategy was immediately put to the test in an investigator-initiated randomised controlled trial.
Project Results:
Shared data platform
A platform to share data was developed within the HATICE project. This platform provides a way for HATICE partners to share data from the three recently completed RCTs, in order to carry out separate and pooled data analysis. In the platform raw data can be uploaded, which is then automatically recoded to uniform encodings between the studies. Subsequently the recoded datasets can be merged. Also the data of the HATICE trial will soon be shared via the shared data platform. Only HATICE partners have access to the shared data platform.
Data pooled data set
Individual participant data were pooled from three recently completed RCTs with a total of 6435 participants. These were the following multi-domain interventions: the Prevention of dementia by intensive vascular care trial (preDIVA, ISRCTN 29711771)(1), the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability trial (FINGER, NCT 01041989)(2) and the ‘Multidomain Alzheimer Preventive Trial (MAPT, NCT 00672685)’ (3). The intervention was operationalized differently in the three trials, but all targeted vascular risk factors aiming to prevent cognitive decline and /or dementia. The pooled dataset consisted of 172 variables, of which 101 were present in the original FINGER database, 105 in MAPT and 91 in preDIVA.
Internet intervention platform
An interactive Internet intervention platform was designed for older people.(4) The development of the platform followed five phases: (1) conceptual framework; (2) platform concept and functional design; (3) platform building (software and content); (4) testing and pilot study; and (5) final product. We performed a meta-analysis, reviewed guidelines for cardiovascular diseases, and consulted end users, experts, and software developers to create the platform concept and content. The software was built in iterative cycles. In the pilot study, 41 people aged approximately 65 years used the platform for 8 weeks. Participants used the interactive features of the platform and appreciated the coach support. During all phases adjustments were made to incorporate all improvements from the previous phases. The final platform is a personal, secured, and interactive platform supported by a coach.
Data intervention trial
A myriad of data has been collected during 18 months of follow up in the 2724 HATICE participants. Not only the BMI, systolic blood pressure and LDL cholesterol for the primary outcome, but also for the secondary outcomes: an extensive cognitive test battery, information on depression (GDS) and anxiety (HADS), diet (MEDAS), disability and functioning with the late life function and disability instrument (LLFDI), self-efficacy with the Partners in Health questionnaire (PIH), physical activity with the community health activities model program for seniors questionnaire (CHAMPS), and quality of life with the EuroQol (EQ5D) and blood was drawn for assessment of lipids, glucose, glycosylated haemoglobin (HbA1c) and c-reactive protein. The effect of the intervention on all of these outcomes has been analyzed and a manuscript has been drafted and submitted to a high impact international peer reviewed journal.
1. Moll van Charante, E.P. et al., Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. The Lancet, 2016. 388(10046): p. 797-805.
2. Ngandu, T., et al., A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. The Lancet, 2015. 385(9984): p. 2255-2263.
3. Andrieu, S., et al., Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol, 2017. 16(5): p. 377-389.
4. Jongstra S, Beishuizen C, Andrieu S, Barbera M, van Dorp M, van de Groep B, Guillemont J, Mangialasche F, van Middelaar T, Moll van Charante P, Soininen H, Kivipelto M, Richard E. Development and Validation of an Interactive Internet Platform for Older People: The Healthy Ageing Through Internet Counselling in the Elderly Study. Telemed J E Health. 2017 Feb;23(2):96-104. doi: 10.1089/tmj.2016.0066. Epub 2016 Jul 27.
Potential Impact:
Potential impact
Shared data platform
- The data of the preDIVA trial, FINGER trial and MAPT trial have been pooled in the shared data platform developed within HATICE. The pooled data have been used for identification of characteristics that either impede or stimulate optimal management of multiple cardiovascular diseases or risk factors and will be used for many more pooled analyses like the ongoing analyses on the effect of the three interventions on cognition and cardiovascular risk factors making specific subgroup analyses possible that would not be achievable based on the data of the individual studies due to the sample size. Thereby the data in the platform is used trial development as well as to scientific advances.
- The data sharing platform is generic and can be used to pool many other studies
Intervention platform for the randomised controlled trial
- The developed HATICE interactive internet intervention with minimal total cost of ownership is easily adaptable for use in other EU member states and their health-care systems. It allows for tailor-made interventions specifically suited to the needs of older persons and will engage and thus empower older persons by shifting the locus of control from traditional health care providers to the elderly themselves.
- The developed HATICE interactive internet intervention platform lays the foundation for future (international) prevention or treatment strategies. An ongoing example is that HATICE will form the basis of a mHealth intervention in older people with low SES in the UK and in China (PRODEMOS, H2020, grant agreement no 779238).
- If implemented, the internet-based intervention strategy is expected to reduce new cardiovascular events and possibly also dementia in the elderly population in the long term. Because of the high costs that are associated with stroke, myocardial infarction and cognitive impairment it is highly likely that any risk reduction will eventually lead to lowering of healthcare costs. But also short term reductions of health care costs can be achieved because the internet platform itself can reduce the need for scheduled office consultations.
Trial results
- Knowledge on the specific results of the randomised trial on the effects of the interactive internet intervention stimulating coach-supported self-management will enable health policy stakeholders throughout the EU to optimize national prevention programs. Furthermore, our results contribute the design of evidence based interventions.
- The manuscript of the trial results has been drafted and is submitted to a high impact peer reviewed journal. The cost effectiveness analyses are currently being performed.
Dissemination activities
In total, 15 manuscripts were published in peer reviewed international papers by the HATICE consortium and many manuscripts are in the pipeline. Furthermore, there were the following dissemination activities:
- 89 oral presentations to a scientific event and 57 to a wider public
- 39 posters were presented at a scientific event
- 4 articles published in the popular press
- 5 interviews, 2 videos, and 6 tv clips
- 2 media briefings and 2 press releases
All dissemination activities are shown in the table A1.
Exploitation of the results
The knowledge acquired in the HATICE project as well as the internet intervention platform will be used as the basis for the development of a mHealth intervention in older people with low SES in the UK and in China (PRODEMOS, H2020, grant agreement no 779238).
List of Websites:
Public website address: http://www.hatice.eu/
Contact via the contact form on the website: http://www.hatice.eu/contact