WWW.HATICE.EU

Healthy Aging

Through Internet Counselling

in the Elderly

 

 

Collaborative project co-funded by the European Unions' Seventh Framework Programme (FP7, 2007-2013) under grant agreement No 305374.

flag European Union   logo FP7 Cooperation

 

The results of the MAPT trial have recently been published in Lancet Neurology(1). The 3-year MAPT study was the first trial to evaluate the effectiveness of a multidomain lifestyle intervention, omega-3 fatty acid supplementation, or both interventions combined, compared to a placebo, on cognitive decline. In the main analysis, there were no significant effects on cognitive decline. However, the results of exploratory subgroup analyses suggested that the combined polyunsaturated fatty acid and multidomain intervention or the multidomain intervention alone might help to slow cognitive decline in people most likely to undergo decline—i.e., those with an increased dementia risk score, and those with evidence of brain amyloid pathology. This publication concludes the very successful range of publications of the finished trials in the HATICE consortium. Previously, the FINGER trial showed in the Lancet(2) that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population. PreDIVA showed in a secondary analysis in the Lancet(3) that 6 years of nurse-led intensive vascular care did not lead to a reduction of all-cause dementia, but seemed effective for the prevention of dementia in participants with untreated baseline hypertension at baseline and persons adherent to the intervention. The data of these trials were pooled in a specially designed pooled data platform to provide valuable input for the design of the HATICE trial on the effects of a blended internet intervention which included 2725 participants and will be finished in December 2017(4).

References
1. Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes 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.
2. Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, 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. Lancet. 2015;385(9984):2255-63.
3. Moll van Charante EP, Richard E, Eurelings LS, van Dalen JW, Ligthart SA, van Bussel EF, et al. Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. Lancet. 2016.
4. Richard E, Jongstra S, Soininen H, Brayne C, Moll van Charante EP, Meiller Y, et al. Healthy Ageing Through Internet Counselling in the Elderly: the HATICE randomised controlled trial for the prevention of cardiovascular disease and cognitive impairment. BMJ Open. 2016;6(6):e010806.

Over 2 years ago, the HATICE trial started recruitment of older people (>=65 years) at increased risk of cardiovascular disease and dementia. Participants randomized to the intervention group have access to an interactive internet platform, stimulating self-management of vascular risk factors, with remote support by a coach. Participants in the control group have access to a static internet platform with basic health information. We will assess the impact of the intervention on the cardiovascular risk profile and the risk of cardiovascular disease and cognitive decline. In September 2016, the last of a total of 2725 participants was recruited for the HATICE trial. Baseline data collection is very complete with less than 1% missing values.

The 12 months and final (18 months) assessments are going very smoothly. According to schedule, by 15 April in total 1764 (65%) participants have finished the 12 months assessment and 673 (25%) participants also finished the final assessment. In total 194 participants (7%) have dropped out, of whom 10 (5%) were retrieved at the final visit. Of the intervention participants, 70% is a regular and persistent user of the platform (>1 time a month). The assessments will be finished in December 2017 and the results will be published in a peer reviewed international journal.

consortium2
On 2 June 2016 the bi-annual General Assembly consortium meeting with representatives from each institution took place in Amsterdam. During this meeting the finalizing of the recruitment phase, the first experiences with the 12 months assessment and boost, and the final touch for the 18 months assessment were discussed. Also the first analyses on the baseline data were presented. It was also time to look ahead on building additional options into the shared data platform and further to utilizing the extensive data collection, beyond the plans that are already there. Also plans are made for future cooperation, beyond HATICE. It was a profitable day, underlining the next phase for HATICE.

Intensive treatment of cardiovascular risk factors had no significant preventive effect on dementia in the preDIVA study (‘Prevention of Dementia by Intensive Vascular Care’): the first investigation on intensive vascular care and dementia prevention.

For the preDIVA study 3526 Dutch men and women aged 70-78 years were randomized to either intensive vascular care or standard care. The intervention comprised of four-monthly visits to a practice nurse in the GP practice, over a period of six years (18 visits). During these visits, cardiovascular risk factors were scrutinized: smoking habits, diet, physical activity, weight, and blood pressure. Blood glucose and lipids were assessed every two years and when indicated otherwise. Based on these assessments, individually tailored lifestyle advice was given according to a detailed protocol conform prevailing Dutch GP-guidelines on cardiovascular risk management and supported by motivational interviewing techniques. If indicated, drug treatment of hypertension, dyslipidemia, and type 2 diabetes mellitus (T2DM) was initiated or optimised.

During a follow-up of 6-8 years, dementia developed in 233 participants. The incidence of dementia was 8% lower in the intervention group than in the control group, though this difference was not significant. The protective effect of the intensive vascular care was bigger in those compliant to the treatment, and in the group with hypertension and not using antihypertensive medication at baseline.
The modest result may be due to primary care settings already providing high standards of cardiovascular risk management (CVRM) in the Netherlands, making it difficult to improve overall efficacy, especially for secondary cardiovascular prevention. Multi-domain interventions to prevent dementia might have a larger impact in low and middle income countries because of the lower standards of care and given the projected increase in hypertension, incident cardiovascular disease and dementia in these settings. Especially if vascular care is started at a younger age, in people with a high dementia risk and with extra attention to compliance.

Principal investigator Van Gool concludes: “Knowledge on dementia prevention goes with baby-steps. This study shows that there is no magical bullet. But it also gave us concrete clues which people to target to prevent dementia.”

The results of the preDIVA study were published in the LANCET. As part of the HATICE project, the preDIVA data are pooled with 2 other large dementia prevention trials.

Edo esocFrom May 9th till May 12th 2016 the second ESOC (European Stroke Organisation Conference) took place in Barcelona, Spain. Edo Richard presented encouraging data on the PreDIVA trial, which illustrated the effect of a multidomain intervention on cognitive functioning in general practice. With more than 3000 attendees this was a perfect opportunity to let the world know about PreDIVA. HATICE was also enthusiastically presented in the poster area with posters on the 'baseline characteristics HATICE' and 'blood pressure variability in PreDIVA'.