Clinical trial NCT02592187: A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)
Official title: A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Life-logging
Cognitive Training
Mild Cognitive Impairment
Memory
Information and communications technology (ICT) in healthcare
Portable camera
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
Collaborators: name: University of Barcelona
name: Associació Vallès Amics de la Neurologia
name: Fundació La Marató de TV3
First posted: 2015-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in memory after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
measure: Change in attention after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
measure: Change in working memory after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
measure: Change in executive function, set-shifting after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
measure: Change in executive function,verbal fluency
timeFrame: after 16 sessions treatment and 3 months
measure: Change in executive function, inhibition after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
measure: Change in processing speed after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
Secondary outcomes:
measure: Change in subjective memory complaints after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
measure: Change in functional capacity after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
measure: Change in depression and anxiety after receiving treatment
timeFrame: after 16 sessions treatment and 3 months
measure: Change in quality of life
timeFrame: after 16 sessions treatment and 3 months
measure: Change in Neuropsychiatric symptoms
timeFrame: after 16 sessions treatment and 3 months
measure: Change in Caregiver Burden
timeFrame: after 16 sessions treatment and 3 months
measure: Change in patient's self-esteem
timeFrame: after 16 sessions treatment and 3 months
measure: Change in patient and caregiver's perception of social support
timeFrame: after 16 sessions treatment and 3 months
measure: Change in neuroplasticiy
timeFrame: after 16 sessions treatment and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Maite Garolera, PhD
role: PRINCIPAL_INVESTIGATOR
References: