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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ReMemory-MCI training
Control intervention
Sponsored by
Consorci Sanitari de Terrassa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Life-logging, Cognitive Training, Mild Cognitive Impairment, Memory, Information and communications technology (ICT) in healthcare, Portable camera

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental intervention

    Control intervention

    Arm Description

    ReMemory-MCI training

    Control intervention

    Outcomes

    Primary Outcome Measures

    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.
    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)
    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).
    Change in executive function, set-shifting after receiving treatment
    Set-shifting was measured using the Colors Trails Test
    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
    Change in executive function, inhibition after receiving treatment
    Inhibition was measured using the Five Digit Test
    Change in processing speed after receiving treatment
    Processing speed was measured using the Detection Task from the computerized neurocognitive battery Cogstate battery

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 31, 2015
    Last Updated
    January 9, 2019
    Sponsor
    Consorci Sanitari de Terrassa
    Collaborators
    University of Barcelona, Associació Vallès Amics de la Neurologia, Fundació La Marató de TV3
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02592187
    Brief Title
    A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)
    Acronym
    ReMemory-MCI
    Official Title
    A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    February 2019 (Anticipated)
    Study Completion Date
    February 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Consorci Sanitari de Terrassa
    Collaborators
    University of Barcelona, Associació Vallès Amics de la Neurologia, Fundació La Marató de TV3

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment
    Keywords
    Life-logging, Cognitive Training, Mild Cognitive Impairment, Memory, Information and communications technology (ICT) in healthcare, Portable camera

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental intervention
    Arm Type
    Experimental
    Arm Description
    ReMemory-MCI training
    Arm Title
    Control intervention
    Arm Type
    Active Comparator
    Arm Description
    Control intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    ReMemory-MCI training
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control intervention
    Primary Outcome Measure Information:
    Title
    Change in memory after receiving treatment
    Description
    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.
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in attention after receiving treatment
    Description
    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)
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in working memory after receiving treatment
    Description
    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).
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in executive function, set-shifting after receiving treatment
    Description
    Set-shifting was measured using the Colors Trails Test
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in executive function,verbal fluency
    Description
    erbal Fluency was measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animals
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in executive function, inhibition after receiving treatment
    Description
    Inhibition was measured using the Five Digit Test
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in processing speed after receiving treatment
    Description
    Processing speed was measured using the Detection Task from the computerized neurocognitive battery Cogstate battery
    Time Frame
    after 16 sessions treatment and 3 months
    Secondary Outcome Measure Information:
    Title
    Change in subjective memory complaints after receiving treatment
    Description
    subjective memory complaints was measured using Memory Faiures of EveryDay (MFE) Test
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in functional capacity after receiving treatment
    Description
    Functional capacity was measured using Functional Assessment Questionnaire (FAQ) and the UCSD Performance-Based Skills Assessment (UPSA).
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in depression and anxiety after receiving treatment
    Description
    depression and anxiety were measured using the Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in quality of life
    Description
    Quality of life was measured using Quality of Life-Alzheimer Disease (QoL-AD)
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in Neuropsychiatric symptoms
    Description
    Neuropsychiatric symptoms was measured using Neuropsychiatric Inventory Questionnaire (NPI)
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in Caregiver Burden
    Description
    Caregiver Burden was measured using the Zarit Caregiver Burden Scale
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in patient's self-esteem
    Description
    Self-Esteem was measured using the Rosenberg Self-Esteem Scale
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in patient and caregiver's perception of social support
    Description
    Perception of social support was measured using the Duke-UNC Functional Social Support Questionnaire
    Time Frame
    after 16 sessions treatment and 3 months
    Title
    Change in neuroplasticiy
    Description
    neuroplasticiy was measured using Brain-derived neutrophic factor (BDNF) serum levels
    Time Frame
    after 16 sessions treatment and 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maite Garolera, PhD
    Organizational Affiliation
    Consorci Sanitari de Terrassa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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