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

NCT ID: NCT02592187

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-02-28

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.

Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental intervention

ReMemory-MCI training

Group Type EXPERIMENTAL

ReMemory-MCI training

Intervention Type BEHAVIORAL

Control intervention

Control intervention

Group Type ACTIVE_COMPARATOR

Control intervention

Intervention Type BEHAVIORAL

Interventions

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ReMemory-MCI training

Intervention Type BEHAVIORAL

Control intervention

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Barcelona

OTHER

Sponsor Role collaborator

Associació Vallès Amics de la Neurologia

OTHER

Sponsor Role collaborator

Fundació La Marató de TV3

OTHER

Sponsor Role collaborator

Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Maite Garolera

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maite Garolera, PhD

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari de Terrassa

Other Identifiers

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Fundacio la MaratóTV3 20141510

Identifier Type: -

Identifier Source: org_study_id

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