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

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ClinicalTrials.gov Identifier: NCT02592187
Recruitment Status : Active, not recruiting
First Posted : October 30, 2015
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
University of Barcelona
Associació Vallès Amics de la Neurologia
Fundació La Marató de TV3
Information provided by (Responsible Party):
Maite Garolera, Consorci Sanitari de Terrassa

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: ReMemory-MCI training Behavioral: Control intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)
Study Start Date : June 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: Experimental intervention
ReMemory-MCI training
Behavioral: ReMemory-MCI training
Active Comparator: Control intervention
Control intervention
Behavioral: Control intervention



Primary Outcome Measures :
  1. Change in memory after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    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.

  2. Change in attention after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    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)

  3. Change in working memory after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    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).

  4. Change in executive function, set-shifting after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    Set-shifting was measured using the Colors Trails Test

  5. Change in executive function,verbal fluency [ Time Frame: after 16 sessions treatment and 3 months ]
    erbal Fluency was measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animals

  6. Change in executive function, inhibition after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    Inhibition was measured using the Five Digit Test

  7. Change in processing speed after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    Processing speed was measured using the Detection Task from the computerized neurocognitive battery Cogstate battery


Secondary Outcome Measures :
  1. Change in subjective memory complaints after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    subjective memory complaints was measured using Memory Faiures of EveryDay (MFE) Test

  2. Change in functional capacity after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    Functional capacity was measured using Functional Assessment Questionnaire (FAQ) and the UCSD Performance-Based Skills Assessment (UPSA).

  3. Change in depression and anxiety after receiving treatment [ Time Frame: after 16 sessions treatment and 3 months ]
    depression and anxiety were measured using the Hospital Anxiety and Depression Scale (HADS)

  4. Change in quality of life [ Time Frame: after 16 sessions treatment and 3 months ]
    Quality of life was measured using Quality of Life-Alzheimer Disease (QoL-AD)

  5. Change in Neuropsychiatric symptoms [ Time Frame: after 16 sessions treatment and 3 months ]
    Neuropsychiatric symptoms was measured using Neuropsychiatric Inventory Questionnaire (NPI)

  6. Change in Caregiver Burden [ Time Frame: after 16 sessions treatment and 3 months ]
    Caregiver Burden was measured using the Zarit Caregiver Burden Scale

  7. Change in patient's self-esteem [ Time Frame: after 16 sessions treatment and 3 months ]
    Self-Esteem was measured using the Rosenberg Self-Esteem Scale

  8. Change in patient and caregiver's perception of social support [ Time Frame: after 16 sessions treatment and 3 months ]
    Perception of social support was measured using the Duke-UNC Functional Social Support Questionnaire

  9. Change in neuroplasticiy [ Time Frame: after 16 sessions treatment and 3 months ]
    neuroplasticiy was measured using Brain-derived neutrophic factor (BDNF) serum levels



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592187


Sponsors and Collaborators
Consorci Sanitari de Terrassa
University of Barcelona
Associació Vallès Amics de la Neurologia
Fundació La Marató de TV3
Investigators
Principal Investigator: Maite Garolera, PhD Consorci Sanitari de Terrassa

Responsible Party: Maite Garolera, Doctor, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier: NCT02592187     History of Changes
Other Study ID Numbers: Fundacio la MaratóTV3 20141510
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Keywords provided by Maite Garolera, Consorci Sanitari de Terrassa:
Life-logging
Cognitive Training
Mild Cognitive Impairment
Memory
Information and communications technology (ICT) in healthcare
Portable camera

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders