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

Toulouse University Hospital

Status: Completed

Conditions: Aged

Treatments: Device: ICT Multidomain Intervention Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03336320

RC31/17/0071

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 120 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Multidomain Intervention Group

Experimental group

Description:

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.

Treatment:

Device: ICT Multidomain Intervention Training

Control Group

Active Comparator group

Description:

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.

Treatment:

Device: ICT Multidomain Intervention Training