Clinical trial NCT03336320: Feasibility and Acceptability of a Web-based Multidomain Intervention to Maintain Cognitive Function in Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Fondation pour la Recherche Médicale
First posted: 2017-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Compliance to the protocol
timeFrame: Assessment at the end of the intervention: 6 months after the inclusion
measure: Content analysis from recorded interviews
timeFrame: Assessment at the end of the intervention: 6 months after the inclusion
Secondary outcomes:
measure: Score from MMSE
timeFrame: Assessment of these measures at the end of the intervention: 6 months after the inclusion
measure: Score FCSRT
timeFrame: Assessment of these measures at the end of the intervention: 6 months after the inclusion
measure: Score DSST
timeFrame: Assessment of these measures at the end of the intervention: 6 months after the inclusion
measure: Score Fluency tests
timeFrame: Assessment of these measures at the end of the intervention: 6 months after the inclusion
measure: Physical activity Monitoring
timeFrame: Assessment of these measures at the end of the intervention: 6 months after the inclusion
measure: Short Physical Performance Battery
timeFrame: Assessment of these measures at the end of the intervention: 6 months after the inclusion
measure: Mini-Nutritional Assessment (MNA)
timeFrame: Assessment of these measures at the end of the intervention: 6 months after the inclusion
measure: Health-related quality of life and Health economic Euro-QoL 5D-3L
timeFrame: Assessment of these measures at the end of the intervention: 6 months after the inclusion
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital (CHU de Toulouse)
Study officials:
affiliation: Gérontopôle, CHU Toulouse
name: Bruno VELLAS, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrieu S, Coley N, Lovestone S, Aisen PS, Vellas B. Prevention of sporadic Alzheimer's disease: lessons learned from clinical trials and future directions. Lancet Neurol. 2015 Sep;14(9):926-944. doi: 10.1016/S1474-4422(15)00153-2. Epub 2015 Jul 23.
citation: Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
citation: Vellas B, Carrie I, Gillette-Guyonnet S, Touchon J, Dantoine T, Dartigues JF, Cuffi MN, Bordes S, Gasnier Y, Robert P, Bories L, Rouaud O, Desclaux F, Sudres K, Bonnefoy M, Pesce A, Dufouil C, Lehericy S, Chupin M, Mangin JF, Payoux P, Adel D, Legrand P, Catheline D, Kanony C, Zaim M, Molinier L, Costa N, Delrieu J, Voisin T, Faisant C, Lala F, Nourhashemi F, Rolland Y, Van Kan GA, Dupuy C, Cantet C, Cestac P, Belleville S, Willis S, Cesari M, Weiner MW, Soto ME, Ousset PJ, Andrieu S. MAPT STUDY: A MULTIDOMAIN APPROACH FOR PREVENTING ALZHEIMER'S DISEASE: DESIGN AND BASELINE DATA. J Prev Alzheimers Dis. 2014 Jun;1(1):13-22.