Efficacy of a Digital Health App Five Lives MED to Improve Cognitive Function in Patients With Mild Cognitive Impairment: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- SharpTx
- Enrollment
- 170
- Locations
- 7
- Primary Endpoint
- Montreal Cognitive Assessment (MoCA)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
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)
- •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.
Outcomes
Primary Outcomes
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline and Study Exit (12 weeks)
The pen and paper, full version of the Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to detect mild cognitive impairment (MCI) and early signs of dementia. It evaluates several cognitive domains, including short-term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. The MoCA is scored out of 30 points, with a score of 26 or above considered normal. Lower scores indicate potential cognitive impairment, with specific ranges often used to gauge the severity: 18-25 for mild cognitive impairment, 10-17 for moderate cognitive impairment, and below 10 for severe cognitive impairment.
Secondary Outcomes
- Mild Behavioural Impairment Checklist (MBI-C)(Baseline and Study Exit (12 weeks))
- Amsterdam IADL Questionnaire (A-IADL-Q-SV)(Baseline and Study Exit (12 weeks))
- D-KEFS Trail Making Test(Baseline and Study Exit (12 weeks))
- 30-second Chair Stand test (30CST)(Baseline and Study Exit (12 weeks))
- Five Lives cognitive tests(Baseline and Study Exit (12 weeks))
- QoL in Alzheimer's disease (QOL-AD)(Baseline and Study Exit (12 weeks))
- Alzheimer's Disease Knowledge Scale (ADKS)(Baseline and Study Exit (12 weeks))
- International Physical Activity Questionnaire (IPAQ)(Baseline and Study Exit (12 weeks))