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Completed

NCT Number: NCT03336320

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

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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Key information

Conditions

Aged

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICT Multidomain Intervention Training

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.

Other names: Information and Communications Technologies

Primary outcomes

  1. Compliance to the protocol

    Time frame: Assessment at the end of the intervention: 6 months after the inclusion

    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)

  2. Content analysis from recorded interviews

    Time frame: Assessment at the end of the intervention: 6 months after the inclusion

    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)

Secondary outcomes

  1. Score from MMSE

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

    score from MMSE

  2. Score FCSRT

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

    Score from FCSRT

  3. Score DSST

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

    score DSST

  4. Score Fluency tests

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

    Score Fluency tests

  5. Physical activity Monitoring

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

    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

  6. Short Physical Performance Battery

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

    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.

  7. Mini-Nutritional Assessment (MNA)

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

    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).

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

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

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Fondation pour la Recherche Médicale

Registry information

Official study 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

Acronym: eMIND

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2017
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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