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

Study Overview
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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.

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).

Official Title
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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

Conditions
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Aged

Intervention / Treatment
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* Device: ICT Multidomain Intervention Training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidomain Intervention Group<br>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<br>* 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.<br>* Other names: Information and Communications Technologies;|
| Active Comparator: Control Group<br>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<br>* 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.<br>* Other names: Information and Communications Technologies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Assessment at the end of the intervention: 6 months after the inclusion | 
| 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) | Assessment at the end of the intervention: 6 months after the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score from MMSE | score from MMSE | Assessment of these measures at the end of the intervention: 6 months after the inclusion | 
| Score FCSRT | Score from FCSRT | Assessment of these measures at the end of the intervention: 6 months after the inclusion | 
| Score DSST | score DSST | Assessment of these measures at the end of the intervention: 6 months after the inclusion | 
| Score Fluency tests | Score Fluency tests | Assessment of these measures at the end of the intervention: 6 months after the inclusion | 
| 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 | Assessment of these measures at the end of the intervention: 6 months after the inclusion | 
| 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. | Assessment of these measures at the end of the intervention: 6 months after the inclusion | 
| 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). | Assessment of these measures at the end of the intervention: 6 months after the inclusion | 
| 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. | Assessment of these measures at the end of the intervention: 6 months after the inclusion |