Feasibility and Acceptability of a Web-based Multidomain Intervention to Maintain Cognitive Function in Older Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-23

Study Completion Date

2019-10-31

Brief Summary

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The primary purpose of the protocol is to evaluate the feasibility and acceptability of a home-based (using information and communication technologies) intervention composed of nutritional counselling, exercise and cognitive training in older adults and its potential effect on various health outcomes.

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Detailed Description

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Nutritional interventions, physical exercise and cognitive training have been used to delay cognitive decline during aging, with mixed results being obtained. However, few studies have investigated the health benefits of combining two or more of those interventions (ie, the so-called multidomain approach) in older adults. Intensive in-person multidomain intervention may difficultly be translated into the "real world" of healthcare systems because currently unpractical.

Therefore, (cost-)effective interventions provided at distance and without the physical presence of healthcare professionals have the potential to be better translatable from research to real life. Information and Communications Technologies (ICT) have a crucial role to play in this context. However, to the best of our knowledge, no studies have investigated the effects of an ICT multidomain intervention on cognition in the elderly yet.

Thus, the main objective of eMIND is to test the feasibility and acceptability of a 6-month, home-based multidomain intervention composed of nutritional counselling, exercise, and cognitive training provided using ICT solutions in people aged 65 or over.

Secondary objectives include to obtaining preliminary data on the effects of the intervention on clinical outcomes in order to inform the design and sample size calculations of a future trial.

eMIND has a mixed design, being composed of a randomized controlled trial (RCT, with two groups: the ICT multidomain intervention group vs Control Group) and a qualitative study (semi-structured interview to assess the easiness-of-use of the website).

Conditions

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Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Multidomain Intervention Group

Home-based multidomain intervention composed of nutritional counselling, exercise (balance, gait, , and cognitive training provided using ICT solutions. A web platform, containing information, questionnaires, videos, games, and tests related to each one of the three components of the multidomain intervention will be made available to participants in this group.

Group Type EXPERIMENTAL

ICT Multidomain Intervention Training

Intervention Type DEVICE

Intervention composed of cognitive training (reasoning and memory training), nutritional counselling (advices to raise awareness about the importance of promoting a diversified and balanced diet), and physical exercises (program and monitoring of progression). The access of control group to the website will be limited to general information about eMIND study and links to the website of health authorities regarding to the healthy ageing topics.

Control Group

Participants from CG will also be equipped with wrist worn accelerometers (that will record daily activity data continuously) but contrary to MIG, participants won't have access to the password encrypted application, and therefore, to the multidomain intervention. However, they will be able to access the study website with overall information on the eMIND study and links to the website of health authorities (such as "http://www.mangerbouger.fr/PNNS" or the World Health Organization "http://www.who.int/topics/ageing/fr/") regarding healthy ageing topics. Plus, in order to control for the social aspect of MIG, participants in CG will receive monthly phone calls from the research team.

Group Type ACTIVE_COMPARATOR

ICT Multidomain Intervention Training

Intervention Type DEVICE

Intervention composed of cognitive training (reasoning and memory training), nutritional counselling (advices to raise awareness about the importance of promoting a diversified and balanced diet), and physical exercises (program and monitoring of progression). The access of control group to the website will be limited to general information about eMIND study and links to the website of health authorities regarding to the healthy ageing topics.

Interventions

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ICT Multidomain Intervention Training

Intervention composed of cognitive training (reasoning and memory training), nutritional counselling (advices to raise awareness about the importance of promoting a diversified and balanced diet), and physical exercises (program and monitoring of progression). The access of control group to the website will be limited to general information about eMIND study and links to the website of health authorities regarding to the healthy ageing topics.

Intervention Type DEVICE

Other Intervention Names

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Information and Communications Technologies

Eligibility Criteria

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Inclusion Criteria

* Mini-mental State Examination ≥ 24
* Presenting subjective memory complaints
* Have easy access to internet (defined as Internet access at home or elsewhere at least twice a week)

Exclusion Criteria

* Terminal illness with life expectancy less than 6 months;
* Diagnosis of dementia of any subtype according with DSM-V
* diagnosis of neurodegenerative diseases, particularly Parkinson's disease;
* Major depression
* unstable cardiovascular condition or any other health condition that might be deteriorated by physical exercise;
* Dependency in ≥ 1 activity of daily living (basic ADL) already participating in structured sessions of physical exercise or cognitive stimulation ≥ 2 times/week in the last 2 months prior to the date of baseline assessments

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No