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
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
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
NCT ID
NCT02592187
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
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)
We'll reach out to this number within 24 hrs