Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

Official title

Efficacy of a Digital Health App Five Lives MED to Improve Cognitive Function in Patients With Mild Cognitive Impairment: a Randomised Controlled Trial

Overview

The goal of this randomized controlled trial is to determine whether the digital health app Five Lives MED can improve cognitive function in people with mild cognitive impairment (MCI). The main question it aims to answer is: Can 12 weeks of using Five Lives MED improve global cognitive function in people diagnosed with MCI? Researchers will compare with a control group who receives a leaflet with standard health information. Participants in the intervention group will be asked to use the Five Lives MED app 3 times per week at home for 12 weeks. All participants, in both groups, will undergo cognitive testing and will complete questionnaires at baseline and exit.

Detailed description

Mild cognitive impairment is a significant public health concern. Non-pharmacological interventions, specifically multi-domain lifestyle and computerised cognitive training interventions, offer an accessible, scalable, engaging and potentially effective solution to improve cognitive function.

Five Lives MED is an interventional digital health app consisting of a physical activity habit forming coaching programme and cognitive training exercises.

The purpose of this study is to evaluate the efficacy of the Five Lives MED device; the primary hypothesis is that there is a significant difference in MoCA scores between the intervention group and the control group after the 12-week Five Lives MED intervention, with an effect size of d = 0.50 or greater favouring the intervention group.

This is a multi-centre, randomised, single-blind, controlled study in participants aged ≥ 50 years with mild cognitive impairment. Participants will be randomly assigned to the intervention (Five Lives MED) or control group for a 12-week period on a 1:1 allocation ratio.

Interventions

• Device Five Lives MED
  Five Lives MED is a mobile application that can be installed on smartphones and tablets using the Android and/or iOS operating systems for use at home. The app offers structured sessions that can be completed once per day. Once the session is completed, the app also offers optional access to additional cognitive training exercises and educational articles. The intervention sessions begins with a Habit Quest, a physical activity habit building tool delivered through a chat bot. Following the Ha

Primary outcome measures

• Montreal Cognitive Assessment (MoCA) [Time frame: Baseline and Study Exit (12 weeks)]

Secondary outcome measures (8)

• Mild Behavioural Impairment Checklist (MBI-C) [Time frame: Baseline and Study Exit (12 weeks)]
• Amsterdam IADL Questionnaire (A-IADL-Q-SV) [Time frame: Baseline and Study Exit (12 weeks)]
• D-KEFS Trail Making Test [Time frame: Baseline and Study Exit (12 weeks)]
• 30-second Chair Stand test (30CST) [Time frame: Baseline and Study Exit (12 weeks)]
• Five Lives cognitive tests [Time frame: Baseline and Study Exit (12 weeks)]
• QoL in Alzheimer's disease (QOL-AD) [Time frame: Baseline and Study Exit (12 weeks)]
• Alzheimer's Disease Knowledge Scale (ADKS) [Time frame: Baseline and Study Exit (12 weeks)]
• International Physical Activity Questionnaire (IPAQ) [Time frame: Baseline and Study Exit (12 weeks)]

Eligibility criteria

Inclusion criteria

• Diagnosis of Mild Cognitive Impairment (also known as mild cognitive disorder \[ICD-10-CM; G31.84\] or mild neurocognitive disorder (DSM-5)
• Age ≥ 50
• Participant or informant is willing and able to give informed consent for participation in the study
• Ability to read and understand English (UK) or French (France)
• Access to a mobile phone (Apple iOS 12.4 or above or Android 6.0 (Marshmallow) or above) or iPad (Apple iOS 12.4 or above only) with internet connection (mobile or WiFi).

Exclusion criteria

• Diagnosis of dementia or evidence of functional impairment inconsistent with MCI
• Severe visual impairment
• Currently undergoing any other cognitive remediation programme
• Currently taking part in any other investigational study that in the opinion of the investigator may impact the data integrity of the current study
• Physical impairment that makes using a mobile device impossible
• Lack of access to an informant
• Participant under guardianship
• Unwilling or unable to tolerate or engage with study procedures
• Physical impairment that makes standing/walking unassisted impossible.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Basic science

Study locations

United Kingdom · 6 centers

• Devon Partnership NHS Trust — Exeter
• Lancashire & South Cumbria NHS Foundation Trust — Preston
• Oxford University Hospitals NHS Foundation Trust — Oxford
• Somerset NHS Foundation Trust — Taunton
• East London NHS Foundation Trust — London
• South London & Maudsley NHS Foundation Trust — London

France · 1 center

• Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris — Paris

Publications

• Gauthier S, Reisberg B, Zaudig M, Petersen RC, Ritchie K, Broich K, Belleville S, Brodaty H, Bennett D, Chertkow H, Cummings JL, de Leon M, Feldman H, Ganguli M, Hampel H, Scheltens P, Tierney MC, Whitehouse P, Winblad B; International Psychogeriatric Association Expert Conference on mild cognitive impairment. Mild cognitive impairment. Lancet. 2006 Apr 15;367(9518):1262-70. doi: 10.1016/S0140-673 PMID 16631882
• Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313. PMID 27042901
• Jongsiriyanyong S, Limpawattana P. Mild Cognitive Impairment in Clinical Practice: A Review Article. Am J Alzheimers Dis Other Demen. 2018 Dec;33(8):500-507. doi: 10.1177/1533317518791401. Epub 2018 Aug 1. PMID 30068225
• Sachdev PS, Lipnicki DM, Kochan NA, Crawford JD, Thalamuthu A, Andrews G, Brayne C, Matthews FE, Stephan BC, Lipton RB, Katz MJ, Ritchie K, Carriere I, Ancelin ML, Lam LC, Wong CH, Fung AW, Guaita A, Vaccaro R, Davin A, Ganguli M, Dodge H, Hughes T, Anstey KJ, Cherbuin N, Butterworth P, Ng TP, Gao Q, Reppermund S, Brodaty H, Schupf N, Manly J, Stern Y, Lobo A, Lopez-Anton R, Santabarbara J; Cohort PMID 26539987
• Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 201 PMID 28735855
• Welstead M, Luciano M, Muniz-Terrera G, Taylor AM, Russ TC. Prevalence of Mild Cognitive Impairment in the Lothian Birth Cohort 1936. Alzheimer Dis Assoc Disord. 2021 Jul-Sep 01;35(3):230-236. doi: 10.1097/WAD.0000000000000433. PMID 33480611
• Gabelle A, Guery M, Doutriaux A, Bettayeb K. Forecasting the Prevalence of Alzheimer's Disease at Mild Cognitive Impairment and Mild Dementia Stages in France in 2022. J Prev Alzheimers Dis. 2023;10(2):259-266. doi: 10.14283/jpad.2023.22. PMID 36946453
• Vlachos GS, Kosmidis MH, Yannakoulia M, Dardiotis E, Hadjigeorgiou G, Sakka P, Ntanasi E, Stefanis L, Scarmeas N. Prevalence of Mild Cognitive Impairment in the Elderly Population in Greece: Results From the HELIAD Study. Alzheimer Dis Assoc Disord. 2020 Apr-Jun;34(2):156-162. doi: 10.1097/WAD.0000000000000361. PMID 31913961

Identifiers

NCT: NCT06598163 · FLMED-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗