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Feasibility Study of a Computerized Cognitive Stimulation (PSCogStim)

Primary Purpose

Mild Cognitive Impairment, So Stated

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computerized Cognitive Stimulation
Multimedia-based internet
Sponsored by
Leila DJABELKHIR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment, So Stated focused on measuring Mild Cognitive Impairment, Computerized Cognitive Stimulation, Cognition, Psychosocial factors

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Mild Cognitive Impairment
  • Absence of history of alcohol or other substance consumption
  • No engagement in other cognitive intervention program

Exclusion Criteria:

  • Psychiatric and neurological disorders
  • Conversion toward dementia during intervention
  • Sensory and or motor deficit that could interfere with the use of computer tool

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Computerized cognitive stimulation

    Multimedia-based internet activities

    Arm Description

    Computerized Cognitive Stimulation was administered to intervention group (IG).

    Multimedia-based internet activities was administered to active control group (ACG).

    Outcomes

    Primary Outcome Measures

    GROBER-BUSCHKE TEST
    Assessment of free and cued recall of episodic memory

    Secondary Outcome Measures

    Technologies Acceptation Questionnaire
    Assessment of acceptability of communication and information technologies

    Full Information

    First Posted
    June 12, 2017
    Last Updated
    June 20, 2017
    Sponsor
    Leila DJABELKHIR
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03195829
    Brief Title
    Feasibility Study of a Computerized Cognitive Stimulation
    Acronym
    PSCogStim
    Official Title
    A Computerized Cognitive Stimulation Program in Elderly With Mild Cognitive Impairment: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Leila DJABELKHIR

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This non-pharmacological interventional feasibility study evaluate a computerized cognitive stimulation program in elderly with mild cognitive impairment.
    Detailed Description
    Involvement in social and leisure activities has been associated with a decreased risk of dementia in the elderly with Mild Cognitive Impairment (MCI). MCI is a crucial phase to prevent the worsening of cognitive decline in elderly at risk to develop dementia. These last years, the use of computerized training programs to enhance cognitive functioning showed positive and promising results. However, the effects on psychosocial factors still poorly documented in cognitive interventions in MCI. It seems essential to promote these factors involving social ties, group dynamic, the motivation, as factors that can contribute to enhance social life and cognitive functioning. This feasibility study evaluated a computer-based cognitive stimulation in elderly with MCI and explore the effects on cognitive and psychosocial components.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, So Stated
    Keywords
    Mild Cognitive Impairment, Computerized Cognitive Stimulation, Cognition, Psychosocial factors

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled pilot study, single blind
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Computerized cognitive stimulation
    Arm Type
    Experimental
    Arm Description
    Computerized Cognitive Stimulation was administered to intervention group (IG).
    Arm Title
    Multimedia-based internet activities
    Arm Type
    Active Comparator
    Arm Description
    Multimedia-based internet activities was administered to active control group (ACG).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Computerized Cognitive Stimulation
    Intervention Description
    The intervention group performed 12-week, 90-minutes per week of cognitive stimulation in group using a tablet with a commercial software with specific exercises to train the cognitive functioning and promote the relation ties in group-session.The program's difficulty level was adjusted to the MMSE score, and was gradually increased.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multimedia-based internet
    Intervention Description
    The active control group had access to different Multimedia contents (travel, photos, music, TV program, cooking recipes) using a tablet, 90-minutes per week each week during 3-months. Each group session was centered in a particular topic, participants were able to select different media free available in Internet.
    Primary Outcome Measure Information:
    Title
    GROBER-BUSCHKE TEST
    Description
    Assessment of free and cued recall of episodic memory
    Time Frame
    Baseline assessment before intervention, change from baseline at 3 months immediately after intervention
    Secondary Outcome Measure Information:
    Title
    Technologies Acceptation Questionnaire
    Description
    Assessment of acceptability of communication and information technologies
    Time Frame
    Baseline assessment before intervention, change from baseline at 3 months immediately after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Mild Cognitive Impairment Absence of history of alcohol or other substance consumption No engagement in other cognitive intervention program Exclusion Criteria: Psychiatric and neurological disorders Conversion toward dementia during intervention Sensory and or motor deficit that could interfere with the use of computer tool
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne-Sophie AR RIGAUD, Professor
    Organizational Affiliation
    Broca University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Feasibility Study of a Computerized Cognitive Stimulation

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