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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Five Lives MED | Experimental | Participants will use the Five Lives MED app, where they will be offered ~30 min daily sessions including a healthy-habit-forming component and cognitive training. They will be able to complete maximum one session per day and will be advised to complete a minimum of 3 sessions per week. The participants can complete more sessions if they wish. After each session they have ad-libitum access to the cognitive-training games and educational articles. |
|
| Control | No Intervention | Participants in the control group will receive an informational leaflet with up-to-date standard advice on sleep hygiene, diet, and physical exercise, with an explanation on how these relate to brain health. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 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. | Baseline and Study Exit (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Mild Behavioural Impairment Checklist (MBI-C) | The Mild Behavioral Impairment Checklist (MBI-C) is a 34-item tool designed to detect the onset of neuropsychiatric symptoms that are significant and persistent, particularly in individuals who are at risk for developing dementia. The MBI-C assesses symptoms across five core domains: decreased motivation, affective dysregulation, impulse control, social inappropriateness, and abnormal perception or thought content. Each item in the checklist is rated based on whether the symptom has been present for at least six months, with severity ratings ranging from mild to severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Kawadler, PhD | Contact | +447850104116 | jamie@fivelives.health | |
| Philip Vassilev, PhD | Contact | +33689397243 | philip@fivelives.health |
| Name | Affiliation | Role |
|---|---|---|
| Ivan Koychev, MD, PhD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Broca, Service de gériatrie Hôpitaux Universitaire Paris Centre, Université Paris Cité | Not yet recruiting | Paris | Île-de-France Region | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16631882 | Background | 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/S0140-6736(06)68542-5. | |
| 27042901 |
| Label | URL |
|---|---|
| World Health Organization. Global Status Report on the Public Health Response to Dementia. World Health Organization; 2021. 137 p. | View source |
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The anonymised IPD may be shared with other organisations and researchers, only if the participant has provided informed consent to do so and only if the data is used for other research that has passed ethical approval. Thus, the plan for IPD sharing is currently undecided as it remains to be determined if study audit will be conducted and if future studies will make use of the IPD.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Baseline and Study Exit (12 weeks) |
| Amsterdam IADL Questionnaire (A-IADL-Q-SV) | The Amsterdam Instrumental Activities of Daily Living Questionnaire - Short Version (A-IADL-Q-SV) is a concise, informant-based tool designed to assess impairments in instrumental activities of daily living (IADL) in individuals with cognitive decline, including those with dementia. The short version consists of 30 items, covering various daily activities such as household tasks, managing finances, using technology, and leisure activities. The total score, or T-score, is normally distributed with a mean of 50 and a standard deviation of 10. The T-score range is approximately 20-80, with higher scores indicating better daily functioning | Baseline and Study Exit (12 weeks) |
| D-KEFS Trail Making Test | The Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test is a neuropsychological assessment used to evaluate various aspects of executive functioning, particularly cognitive flexibility, processing speed, and attention. It consists of five conditions that assess visual scanning, number sequencing, letter sequencing, number-letter switching, and motor speed. Each condition has raw and scaled scores, with higher scaled scores indicating better performance. | Baseline and Study Exit (12 weeks) |
| 30-second Chair Stand test (30CST) | The 30-Second Chair Stand Test (30CST) is a functional fitness test designed to assess lower body strength and endurance, particularly in older adults. The test involves counting how many times an individual can fully stand up from a seated position and sit back down in a chair without using their arms, all within a 30-second period. A higher score indicates better performance. This test is commonly used to evaluate the risk of falls and overall functional mobility in seniors. | Baseline and Study Exit (12 weeks) |
| Five Lives cognitive tests | Five Lives offers five digital cognitive tests via iPad or smartphone, each targeting different cognitive functions.
Higher scores indicate better performance. | Baseline and Study Exit (12 weeks) |
| QoL in Alzheimer's disease (QOL-AD) | The Quality of Life in Alzheimer's Disease (QOL-AD) scale is a 13-item questionnaire designed to assess the quality of life of individuals diagnosed with Alzheimer's disease from both the patients and informants perspectives. It measures areas such as physical health, mood, relationships, and the ability to perform daily activities. Each item is rated on a 4-point scale from 1 (poor) to 4 (excellent), with total scores ranging from 13 to 52, where higher scores indicate a better perceived quality of life. | Baseline and Study Exit (12 weeks) |
| Alzheimer's Disease Knowledge Scale (ADKS) | The Alzheimer's Disease Knowledge Scale (ADKS) is a 30-item true/false questionnaire designed to assess knowledge about Alzheimers disease across several domains, including risk factors, symptoms, diagnosis, treatment, caregiving, and disease progression. Higher scores indicate better knowledge. | Baseline and Study Exit (12 weeks) |
| International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire (IPAQ) is a widely used self-report tool designed to measure physical activity levels. The IPAQ has been adapted for use with older adults, including those aged 65 and above. The IPAQ can be particularly useful in assessing physical activity levels in this demographic, helping to understand the frequency, intensity, and duration of various types of physical activity, such as walking, moderate, and vigorous activities. Scores will be expressed in metabolic equivalent (MET)-min per week, which higher MET-min indicating more physical activity. | Baseline and Study Exit (12 weeks) |
| Devon Partnership NHS Trust | Recruiting | Exeter | Devon | EX2 5AF | United Kingdom |
|
| Lancashire & South Cumbria NHS Foundation Trust | Recruiting | Preston | Lancashire | PR5 6AW | United Kingdom |
|
| Oxford University Hospitals NHS Foundation Trust | Active, not recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| Somerset NHS Foundation Trust | Recruiting | Taunton | Somerset | TA1 5DA | United Kingdom |
|
| East London NHS Foundation Trust | Active, not recruiting | London | E1 8DE | United Kingdom |
| South London & Maudsley NHS Foundation Trust | Active, not recruiting | London | SE5 8AF | United Kingdom |
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