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AgedeMINDNCT03336320

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

A study testing ICT Multidomain Intervention Training in people with Aged, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aged
What is being tested?
ICT Multidomain Intervention Training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteFrance
Study dates
23 Nov 2017to 31 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

France1 site

  • Toulouse University Hospital (CHU de Toulouse)

    Toulouse, 31059

Other trials in France

About this study

Official title: Feasibility and Acceptability of a Web-based Multidomain Intervention With Connected Devices Made to Maintain Cognitive Function in Older Adults: a Pilot Randomised Controlled Trial

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.

Read the detailed 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).

Conditions
Aged
Being tested
ICT Multidomain Intervention Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICT Multidomain Intervention TrainingDevice

    Also called Information and Communications Technologies

    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.

Study groups in NCT03336320
Study groupRoleWhat they receive
Multidomain Intervention GroupExperimentalHome-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.
Receives: Device: ICT Multidomain Intervention Training
Control GroupActive comparatorParticipants 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.
Receives: Device: ICT Multidomain Intervention Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance to the protocol

    Compliance to measure the feasibility of the study: Participants will be asked to connect the physical exercise interface at least twice a week, the cognitive stimulation interface at least twice a week, and the nutritional interface at least once each 15 days. Participants who adhere to >75% of this frequency of web-site use will be considered adheres (quantitative approach)

    Measured: Assessment at the end of the intervention: 6 months after the inclusion

  2. Content analysis from recorded interviews

    a content analysis from recorded interviews that will be conducted at the end of the intervention period to measure the acceptability of the trial procedures (qualitative approach)

    Measured: Assessment at the end of the intervention: 6 months after the inclusion

Secondary outcomes (8)

  1. Score from MMSE

    score from MMSE

    Measured: Assessment of these measures at the end of the intervention: 6 months after the inclusion

  2. Score FCSRT

    Score from FCSRT

    Measured: Assessment of these measures at the end of the intervention: 6 months after the inclusion

  3. Score DSST

    score DSST

    Measured: Assessment of these measures at the end of the intervention: 6 months after the inclusion

  4. Score Fluency tests

    Score Fluency tests

    Measured: Assessment of these measures at the end of the intervention: 6 months after the inclusion

  5. Physical activity Monitoring

    Physical data will automatically be transferred from the wrist-worn activity monitors (Fitbit Flex 2) to the application and will generate data regarding participant's number of steps walked, energy expenditure, and walking speed, in a weekly basis

    Measured: Assessment of these measures at the end of the intervention: 6 months after the inclusion

  6. Short Physical Performance Battery

    Physical function will be evaluated by the validated short performance battery SPPB, which is based on three physical tests: timed short distance walk (4 meters at usual pace), timed repeated chair stands (5-repetition chair rise), and timed balance tests (standing balance) (20). Each of these tests is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the test. A summary score ranging from 0 (worst performers) to 12 (best performers) is calculated by adding walking speed, chair stands and balance scores. From the timed short distance walk test we will calculate participants' walking speed in meters/sec; therefore, although walking speed composes the SPPB overall score, it will also be analyzed separately.

    Measured: Assessment of these measures at the end of the intervention: 6 months after the inclusion

  7. Mini-Nutritional Assessment (MNA)

    This questionnaire is composed of 18 items aiming at classifying older adults as normally nourished (24≤score≤30), at risk of malnutrition (17≤score≤23.5) or malnourished (score<17).

    Measured: Assessment of these measures at the end of the intervention: 6 months after the inclusion

  8. Health-related quality of life and Health economic Euro-QoL 5D-3L

    The health-related quality of life will be assessed by the Euro-QoL 5D-3L, a valid and short questionnaire including five questions on mobility, autonomy, daily activities, pain and depression.

    Measured: Assessment of these measures at the end of the intervention: 6 months after the inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start23 Nov 2017
  3. Primary completion31 Jan 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03336320
Sponsor's protocol ID
RC31/17/0071
Acronym
eMIND
Status last verified
Oct 2021
First submitted
9 Oct 2017
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Andrieu S, Coley N, Lovestone S, Aisen PS, Vellas B. Prevention of sporadic Alzheimer's disease: lessons learned from clinical trials and future directions. Lancet Neurol. 2015 Sep;14(9):926-944. doi: 10.1016/S1474-4422(15)00153-2. Epub 2015 Jul 23.

    PubMed 26213339

  • Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. 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 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

    PubMed 25771249

  • Vellas B, Carrie I, Gillette-Guyonnet S, Touchon J, Dantoine T, Dartigues JF, Cuffi MN, Bordes S, Gasnier Y, Robert P, Bories L, Rouaud O, Desclaux F, Sudres K, Bonnefoy M, Pesce A, Dufouil C, Lehericy S, Chupin M, Mangin JF, Payoux P, Adel D, Legrand P, Catheline D, Kanony C, Zaim M, Molinier L, Costa N, Delrieu J, Voisin T, Faisant C, Lala F, Nourhashemi F, Rolland Y, Van Kan GA, Dupuy C, Cantet C, Cestac P, Belleville S, Willis S, Cesari M, Weiner MW, Soto ME, Ousset PJ, Andrieu S. MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA. J Prev Alzheimers Dis. 2014 Jun;1(1):13-22.

    PubMed 26594639

  • Pothier K, Soriano G, Lussier M, Naudin A, Costa N, Guyonnet S, Piau A, Ousset PJ, Nourhashemi F, Vellas B, de Souto Barreto P. 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. 2018 Sep;30(9):1127-1135. doi: 10.1007/s40520-018-0897-x. Epub 2018 Jan 24.

    PubMed 29368298

Questions about this trial

What is this clinical trial studying?

A study testing ICT Multidomain Intervention Training in people with Aged, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance to the protocol (time frame: Assessment at the end of the intervention: 6 months after the inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03336320, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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