Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598163
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 050 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 11 allocation ratio
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 050 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 11 allocation ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None