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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aged
- Sponsor
- University Hospital, Toulouse
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Compliance to the protocol
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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).
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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)
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
- Score from MMSE(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Score FCSRT(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Score DSST(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Score Fluency tests(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Short Physical Performance Battery(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(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Physical activity Monitoring(Assessment of these measures at the end of the intervention: 6 months after the inclusion)
- Mini-Nutritional Assessment (MNA)(Assessment of these measures at the end of the intervention: 6 months after the inclusion)