Abstract
Background
Multidomain interventions composed of nutritional counseling, exercise and cognitive trainings have shown encouraging results as effective preventive strategies delaying age-related declines. However, these interventions are time- and resource-consuming. The use of Information and Communication Technologies (ICT) might facilitate the translation from research into real-world practice and reach a massive number of people.
Aim
This article describes the protocol of the eMIND study, a randomized controlled trial (RCT) using a web-based multidomain intervention for older adults.
Methods
One hundred and twenty older adults (≥ 65 years), with a spontaneous memory complaint, will be randomly assigned to a six-month web-based multidomain (nutritional counseling, physical and cognitive trainings) intervention group with a connected accelerometer (number of steps, energy expenditure), or to a control group with access to general information on healthy aging plus the accelerometer, but no access to the multidomain intervention. The main outcome is the feasibility/acceptability of the web-based intervention. Secondary clinical outcomes include: cognitive functions, physical performance, nutritional status and cost-effectiveness.
Results
We expect a high amount of adherers (ie, > 75% compliance to the protocol) to reflect the feasibility. Acceptability, assessed through interviews, should allow us to understand motivators and barriers to this ICT intervention. We also expect to provide data on its effects on various clinical outcomes and efficiency.
Conclusion and discussion
The eMIND study will provide crucial information to help developing a future and larger web-based multidomain lifestyle RCT, which should facilitate the translation of this ICT intervention from the research world into real-life clinical practice for the healthcare of older adults.
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Acknowledgements
We would like to thank Arnaud Lendrieux (Direction de la Recherche et de l’Innovation, CHU-Toulouse), and Kathia Saillant who greatly contributed to the elaboration of this project.
Funding
This pilot study is supported by the Fondation pour la Recherche Médicale (FRM DOC20161136208; ID RCB number: 2017-A01018-45). The Centre Hospitalier Universitaire of Toulouse (CHU-Toulouse) is the sponsor of the study (protocol ID: 17 0071).
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Conflict of interest
The authors declare no conflict of interest. The sponsor, the funding agency and the French society that elaborated the eMIND web platform MHComm© had no role in designing this study and will not have any role in the execution of the intervention, in the analyses and interpretation of the data or in the decision to submit results.
Ethical approval
All procedures that will be performed in this pilot study involving human participants are in accordance with the ethical standards of the institutional and/or national research committee (CPP Tours—Région Centre—Ouest 1. Registration Number: 2017T2-10) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Signed informed consent will be obtained from all participants before baseline assessments.
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Pothier, K., Soriano, G., Lussier, M. et al. A web-based multidomain lifestyle intervention with connected devices for older adults: research protocol of the eMIND pilot randomized controlled trial. Aging Clin Exp Res 30, 1127–1135 (2018). https://doi.org/10.1007/s40520-018-0897-x
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DOI: https://doi.org/10.1007/s40520-018-0897-x