A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)

Study Overview
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Brief Summary
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Background: Mild Cognitive Impairment (MCI) is a risk factor for dementia and represents a critical window of opportunity to intervene and alter the trajectory of both cognitive and functional decline. Emerging life-logging technologies has shown a tremendous potential to increase autobiographical memory. Objective: The main goal of the present study is to develop a Cognitive Training program (CT) for MCI based on life-logging captured by a Wearable Camera (WeC) recording specific autobiographical episodes for stimulating posteriorly episodic memory. The challenge is to create an application to manage this large collection of images, which can be easily retrieved as events by users in a therapeutic context as a multimodal cognitive stimulation. The investigators will conduct a quasi-experimental design with non-equivalent control group, evaluating the effectiveness of the life-logging re-experiencing program immediately and 3-month follow-up period. Methodology: The design is a pretest, posttest and follow-up design, where 30 adults with MCI were sequentially allocated to one of two conditions: intervention or control group. All subjects wore a lifelogging WeC during two weeks, and subsequently they were generated several videos with the most relevant information of each event. Subjects in the Intervention Group will attend 1-hour individual training sessions 2 times per week for 14 8 weeks. Main outcomes measures will be cognitive, functional, emotional and quality of life measures, as well as biochemical measures (BDNF). Expected results: The investigators expect the outcomes to provide preliminary evidence that autobiographical experimentation CT programs can positively impact cognitive functioning and may represent an effective strategy to improve memory and functionality in those who begun to experience cognitive decline.

Official Title
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A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: ReMemory-MCI training
* Behavioral: Control intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65-90 years of age Meet definition criteria for MCI (Petersen, 2004) Be receiving CT at least three month in Day Hospital during three months or more; c) having memory complaint, usually verified by an informant Having memory complaint, usually verified by an informant Memory performance below the mean score for the corresponding age and education group Having normal general cognitive functioning as determined by a Mini-Mental State Examination (MMSE) score > o = 24 Having a reliable caregiver who can supervise the patient's daily activities Having Global clinical dementia rating scale score of 0.5 Granted written informed consent accepting to participate in the study Exclusion Criteria: Neurological, psychiatric or unstable medical disorders Intellectual deficiency (Premorbid Intellectual Quotient (IQ) -Vocabulary- less 85) Relevant hearing, vision, motor or language deficits Less than 4 years of education e) acquisition of Catalonian or Spanish languages after 15 years old

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental intervention<br>ReMemory-MCI training | Behavioral: ReMemory-MCI training<br> <br> |
| Active Comparator: Control intervention<br>Control intervention | Behavioral: Control intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in memory after receiving treatment | Memory was measured using the Logical Memory Test from the Wechsler Memory Scale, IV version (WMS-IV, Spanish version); the International Shopping List Task and the One Card Learning Task from the computerized neurocognitive battery Cogstate. | after 16 sessions treatment and 3 months | 
| Change in attention after receiving treatment | Attention was measured using the Identification Task from the computerized neurocognitive battery Cogstate and the Forward Digit Span from the Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) | after 16 sessions treatment and 3 months | 
| Change in working memory after receiving treatment | orking memory was measured using the One Back Task from the computerized neurocognitive battery Cogstate and the Backward Digit Span from the Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV). | after 16 sessions treatment and 3 months | 
| Change in executive function, set-shifting after receiving treatment | Set-shifting was measured using the Colors Trails Test | after 16 sessions treatment and 3 months | 
| Change in executive function,verbal fluency | erbal Fluency was measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animals | after 16 sessions treatment and 3 months | 
| Change in executive function, inhibition after receiving treatment | Inhibition was measured using the Five Digit Test | after 16 sessions treatment and 3 months | 
| Change in processing speed after receiving treatment | Processing speed was measured using the Detection Task from the computerized neurocognitive battery Cogstate battery | after 16 sessions treatment and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective memory complaints after receiving treatment | subjective memory complaints was measured using Memory Faiures of EveryDay (MFE) Test | after 16 sessions treatment and 3 months | 
| Change in functional capacity after receiving treatment | Functional capacity was measured using Functional Assessment Questionnaire (FAQ) and the UCSD Performance-Based Skills Assessment (UPSA). | after 16 sessions treatment and 3 months | 
| Change in depression and anxiety after receiving treatment | depression and anxiety were measured using the Hospital Anxiety and Depression Scale (HADS) | after 16 sessions treatment and 3 months | 
| Change in quality of life | Quality of life was measured using Quality of Life-Alzheimer Disease (QoL-AD) | after 16 sessions treatment and 3 months | 
| Change in Neuropsychiatric symptoms | Neuropsychiatric symptoms was measured using Neuropsychiatric Inventory Questionnaire (NPI) | after 16 sessions treatment and 3 months | 
| Change in Caregiver Burden | Caregiver Burden was measured using the Zarit Caregiver Burden Scale | after 16 sessions treatment and 3 months | 
| Change in patient's self-esteem | Self-Esteem was measured using the Rosenberg Self-Esteem Scale | after 16 sessions treatment and 3 months | 
| Change in patient and caregiver's perception of social support | Perception of social support was measured using the Duke-UNC Functional Social Support Questionnaire | after 16 sessions treatment and 3 months | 
| Change in neuroplasticiy | neuroplasticiy was measured using Brain-derived neutrophic factor (BDNF) serum levels | after 16 sessions treatment and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Life-logging, Cognitive Training, Mild Cognitive Impairment, Memory, Information and communications technology (ICT) in healthcare, Portable camera