Feasibility and Acceptability of a Web-based Multidomain Intervention to Maintain Cognitive Function in Older Adults
- Conditions
- Aged
- Interventions
- Device: ICT Multidomain Intervention Training
- Registration Number
- NCT03336320
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group ICT Multidomain Intervention Training 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. Multidomain Intervention Group ICT Multidomain Intervention Training 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.
- Primary Outcome Measures
Name Time Method Compliance to the protocol 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)
Content analysis from recorded interviews 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
Name Time Method Score from MMSE Assessment of these measures at the end of the intervention: 6 months after the inclusion score from MMSE
Physical activity Monitoring 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
Mini-Nutritional Assessment (MNA) 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).
Score FCSRT Assessment of these measures at the end of the intervention: 6 months after the inclusion Score from FCSRT
Score DSST Assessment of these measures at the end of the intervention: 6 months after the inclusion score DSST
Score Fluency tests Assessment of these measures at the end of the intervention: 6 months after the inclusion Score Fluency tests
Short Physical Performance Battery 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.
Health-related quality of life and Health economic Euro-QoL 5D-3L 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.
Trial Locations
- Locations (1)
Toulouse University Hospital (CHU de Toulouse)
🇫🇷Toulouse, France