Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment

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.

Interventions

• Five Lives MED · DEVICE

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (7)

• Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité, Paris, Île-de-France Region, France · NOT_YET_RECRUITING
• Devon Partnership NHS Trust, Exeter, Devon, United Kingdom · RECRUITING
• Lancashire & South Cumbria NHS Foundation Trust, Preston, Lancashire, United Kingdom · RECRUITING
• Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, United Kingdom · ACTIVE_NOT_RECRUITING
• Somerset NHS Foundation Trust, Taunton, Somerset, United Kingdom · RECRUITING
• East London NHS Foundation Trust, London, United Kingdom · ACTIVE_NOT_RECRUITING
• South London & Maudsley NHS Foundation Trust, London, United Kingdom · ACTIVE_NOT_RECRUITING