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

NCT03336320 | Completed

• 1 other identifier: RC31/17/0071
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

• Physical activity Monitoring

  Assessment of these measures at the end of the intervention: 6 months after the inclusion

Study Arms (2)

Multidomain Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

ICT Multidomain Intervention Training DEVICE

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.

Also known as: Information and Communications Technologies

Control Group; Multidomain Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Fondation pour la Recherche Médicale: collaborator

Study Sites (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

Related Publications (4)

• 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.

  PMID: 26213339 BACKGROUND

• 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.

  PMID: 25771249 BACKGROUND

• 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.

  PMID: 26594639 BACKGROUND

• Pothier K, Soriano G, Lussier M, Naudin A, Costa N, Guyonnet S, Piau A, Ousset PJ, Nourhashemi F, Vellas B, de Souto Barreto P. A web-based multidomain lifestyle intervention with connected devices for older adults: research protocol of the eMIND pilot randomized controlled trial. Aging Clin Exp Res. 2018 Sep;30(9):1127-1135. doi: 10.1007/s40520-018-0897-x. Epub 2018 Jan 24.

  PMID: 29368298 RESULT

Study Officials

• Bruno VELLAS, Pr

  Gérontopôle, CHU Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: November 8, 2017
• Study Start: November 23, 2017
• Primary Completion: January 31, 2019
• Study Completion: October 31, 2019
• Last Updated: December 5, 2025

Record last verified: 2021-10

Locations

FR (1)