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

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ClinicalTrials.gov Identifier: NCT03336320
Recruitment Status : Active, not recruiting
First Posted : November 8, 2017
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
Fondation pour la Recherche Médicale
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

Condition or disease Intervention/treatment Phase
Aged Device: ICT Multidomain Intervention Training Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 23, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: 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.
Device: 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.
Other Name: Information and Communications Technologies

Active Comparator: 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.
Device: 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.
Other Name: Information and Communications Technologies




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336320


Locations
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France
Toulouse University Hospital (CHU de Toulouse)
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Fondation pour la Recherche Médicale
Investigators
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Principal Investigator: Bruno VELLAS, Pr Gérontopôle, CHU Toulouse

Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03336320     History of Changes
Other Study ID Numbers: RC31/17/0071
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No