Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment
Efficacy of a Digital Health App Five Lives MED to Improve Cognitive Function in Patients With Mild Cognitive Impairment: a Randomised Controlled Trial
SharpTx
170 participants
Feb 20, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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 Habit Quest, the participant is guided through a series of gamified cognitive training exercises aimed at improving attention, memory, language and executive function.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06598163