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Maintaining Independence and Quality of Life in Aging Adults Through Targeted Cognitive Training

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ABI Wellness Program
Sponsored by
Kwantlen Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • T-MoCA score between 19 - 23

Exclusion Criteria:

  • Potential participants are under the age of 65 years at the time of screening
  • Scoring results in a range outside of 19-23 on the MoCA
  • Those who have have a diagnosed illness or diagnosed injury which is known to directly and negatively impact cognition
  • Are known (legally) to be deemed incapable; unable to appreciate information that is relevant to making decisions or is unable to appreciate the reasonably foreseeable consequences of either making or not making a decision.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    The "intervention group" will participate in the 6-month interdisciplinary comprehensive rehabilitation program. The ABI Wellness (ABIW) program aimed at this population would be 7 hours a week (2 days per week will be scheduled for the intervention group), consisting of around 4 hours of cognitive training (through specified drills, cognitive exercises focused on executive functioning), 1 hour of physical exercise, 1 hour of mindfulness sessions (meditation) and scheduled break times.

    The "non-intervention" group or control group will have all the same pre-tests administered as the intervention group, however, will not participate in the cognitive program. The control group will be required to complete the assessment periods only, however, keep a record of their daily activities in a log format which is presented in the materials included herein. No other intervention or programming will be provided.

    Outcomes

    Primary Outcome Measures

    Montreal Cognitive Assessment
    Telephone Montreal Cognitive Assessment (T- MoCA) - non-invasive screening tool which takes approximately 10 minutes to complete. Thirty items assessing multiple cognitive domains are contained in the MoCa: short-term memory; visuospatial abilities via clock drawing; and a cube copy task; executive functioning via an adaptation of Trail Making phonemic fluency, and verbal abstraction; attention, concentration, and working memory via target detection, serial subtraction, digits forward, and digits backward; language via confrontation naming with low-familiarity animals, and repetition of complex sentences; and orientation to time and place (Nasreddine et al., 2005). The MoCA is scored by obtaining an item total.
    Memory Alteration Test
    Memory Alteration Test (M@T) - A non-invasive memory screening test used to discriminate between subjects with subjective memory complaints (SMC) Without objective memory impairment and patients with amnesic mild cognitive impairment (A-MCI) and with Mild Alzheimers disease (AD). (M@T), which is a memory screening test, capable for discriminating between subjects with subjective memory complaints (SMC) (without objective memory impairment) and patients with amnestic mild cognitive impairment (A-MCI) and with mild Alzheimer's disease (AD). This is a cognitive test with high internal consistency and validity, short application (5-10 min), easy to perform and to interpret (Carnero-Pardo et al., 2011a).
    Mild Cognitive Impairment Questionnaire
    Mild Cognitive Impairment Questionnaire (MCQ) -QOL will be measured using the 13-item MCQ tool designed to take 5 minutes to administer. The MCQ tool uses a scale of 0-4 (none, rarely, sometimes, often, or always) to assess two constructs - Practical Concerns and Emotional Concerns. Scores are transformed and presented on a metric of 0 (no problems) to 100 (maximum impact of MCI). Scale scores are interpreted using the following guide: a scale score of 0-20 indicates 'never' experiencing the issue, 21-40 'rarely' experiencing it, 41-60 'sometimes' experiencing it,61-80 'often' experiencing it, 81-100 'always' experiencing it. The MCQ has been shown to have great stability and reliability through test-retest and substantial validity with this population.
    Neuro-QOL
    Neuro-QOL This research tool measures the physical, mental, and social effects experienced by adults with neurological conditions. The measurement takes approximately 30 minutes to complete and will be administered three times.

    Secondary Outcome Measures

    Qualitative Interviews
    Interviews - Semi-structured interviews will occur with all participants in the study including the intervention and the control group with a focus upon lived experience specific to quality of life.

    Full Information

    First Posted
    August 31, 2020
    Last Updated
    August 31, 2020
    Sponsor
    Kwantlen Polytechnic University
    Collaborators
    Centre for Aging and Brain Health Innovation, ABI Wellness Inc, Watson Centre Society for Brain Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04539132
    Brief Title
    Maintaining Independence and Quality of Life in Aging Adults Through Targeted Cognitive Training
    Official Title
    Maintaining Independence and Quality of Life in Aging Adults Through Targeted Cognitive Training
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    August 31, 2021 (Anticipated)
    Study Completion Date
    October 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kwantlen Polytechnic University
    Collaborators
    Centre for Aging and Brain Health Innovation, ABI Wellness Inc, Watson Centre Society for Brain Health

    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
    Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease all represent a range of degenerative conditions that have cognitive impairments which all limit the ability for older individuals to self-manage care, participate in daily activities and community participation. The consequences of these progressive diseases increase the requirement for residential care, associated medical costs and may negatively impact the overall quality of life and mental health for individuals. According to the Alzheimer Society of Canada, over the next few decades, more than 1 million Canadian's will be living with decreased cognitive ability and will require an increased amount of support, whether through family or institutional sources. Currently, there are few cognitive programs for individuals diagnosed with mild cognitive impairment or for individuals wishing to maintain their current level of cognitive ability which translates to meaningful improvements in daily living and independence, as well as generalized intelligence. To date, the Watson Centre Society for Brain Health (WCSBH) has successfully improved cognitive capacity, executive function and quality of life for over 100 individuals following a wide range of brain injury, and currently has a 77% return to work rate following completion of the full program. The program includes a combination of physical exercise, cognitive training and mindfulness meditation. The purpose of the research study is to explore the impact of an interdisciplinary cognitive rehabilitation program has upon the cognitive functioning and quality of life for individuals who are assessed to have mild cognitive impairment (MCI). In particular, the aims of this study include: 1) To evaluate changes in cognition and quality life in older adults with MCI. 2) To explore the potential for intensive cognitive intervention in slowing cognitive degeneration in older adults with MCI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participants will be divided into two groups (N = 20). One group will be the "intervention group" who will participate in the 6-month interdisciplinary comprehensive rehabilitation program whereas the "non-intervention" group or control group will have all of the same pre-tests administered as the intervention group, however, will not participate in the cognitive program.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    The "intervention group" will participate in the 6-month interdisciplinary comprehensive rehabilitation program. The ABI Wellness (ABIW) program aimed at this population would be 7 hours a week (2 days per week will be scheduled for the intervention group), consisting of around 4 hours of cognitive training (through specified drills, cognitive exercises focused on executive functioning), 1 hour of physical exercise, 1 hour of mindfulness sessions (meditation) and scheduled break times.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The "non-intervention" group or control group will have all the same pre-tests administered as the intervention group, however, will not participate in the cognitive program. The control group will be required to complete the assessment periods only, however, keep a record of their daily activities in a log format which is presented in the materials included herein. No other intervention or programming will be provided.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ABI Wellness Program
    Intervention Description
    The ABI Wellness program includes a computerized task which will be completed by all participants remotely. The exercise is a sustained visual-spatial processing task of progressively increasing difficulty. Subjects are presented with an analog clock face, initially showing only one hand. The subject uses a keyboard to enter a value for the hour shown. Feedback on the computer screen indicates whether the response is correct or incorrect. If the response was incorrect, the subject continues to respond until the correct response is entered. After this, a new clock face is shown. Once subjects reach a criterion of 90% accuracy over a series of consecutive responses, an additional hand is added to the clock face. Participants will complete the program at home, online, and will be required to be present on a video call during the exercise with the other participants and research assistants. The program is 150 hours over 6 months, through twice weekly 3-hour sessions.
    Primary Outcome Measure Information:
    Title
    Montreal Cognitive Assessment
    Description
    Telephone Montreal Cognitive Assessment (T- MoCA) - non-invasive screening tool which takes approximately 10 minutes to complete. Thirty items assessing multiple cognitive domains are contained in the MoCa: short-term memory; visuospatial abilities via clock drawing; and a cube copy task; executive functioning via an adaptation of Trail Making phonemic fluency, and verbal abstraction; attention, concentration, and working memory via target detection, serial subtraction, digits forward, and digits backward; language via confrontation naming with low-familiarity animals, and repetition of complex sentences; and orientation to time and place (Nasreddine et al., 2005). The MoCA is scored by obtaining an item total.
    Time Frame
    Pre-post assessment completed 6 months apart with a 6 month follow up
    Title
    Memory Alteration Test
    Description
    Memory Alteration Test (M@T) - A non-invasive memory screening test used to discriminate between subjects with subjective memory complaints (SMC) Without objective memory impairment and patients with amnesic mild cognitive impairment (A-MCI) and with Mild Alzheimers disease (AD). (M@T), which is a memory screening test, capable for discriminating between subjects with subjective memory complaints (SMC) (without objective memory impairment) and patients with amnestic mild cognitive impairment (A-MCI) and with mild Alzheimer's disease (AD). This is a cognitive test with high internal consistency and validity, short application (5-10 min), easy to perform and to interpret (Carnero-Pardo et al., 2011a).
    Time Frame
    Pre-post assessment completed 6 months apart with a 6 month follow up
    Title
    Mild Cognitive Impairment Questionnaire
    Description
    Mild Cognitive Impairment Questionnaire (MCQ) -QOL will be measured using the 13-item MCQ tool designed to take 5 minutes to administer. The MCQ tool uses a scale of 0-4 (none, rarely, sometimes, often, or always) to assess two constructs - Practical Concerns and Emotional Concerns. Scores are transformed and presented on a metric of 0 (no problems) to 100 (maximum impact of MCI). Scale scores are interpreted using the following guide: a scale score of 0-20 indicates 'never' experiencing the issue, 21-40 'rarely' experiencing it, 41-60 'sometimes' experiencing it,61-80 'often' experiencing it, 81-100 'always' experiencing it. The MCQ has been shown to have great stability and reliability through test-retest and substantial validity with this population.
    Time Frame
    Pre-post assessment completed 6 months apart with a 6 month follow up
    Title
    Neuro-QOL
    Description
    Neuro-QOL This research tool measures the physical, mental, and social effects experienced by adults with neurological conditions. The measurement takes approximately 30 minutes to complete and will be administered three times.
    Time Frame
    Pre-post assessment completed 6 months apart with a 6 month follow up
    Secondary Outcome Measure Information:
    Title
    Qualitative Interviews
    Description
    Interviews - Semi-structured interviews will occur with all participants in the study including the intervention and the control group with a focus upon lived experience specific to quality of life.
    Time Frame
    Pre-post assessment completed 6 months apart with a 6 month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: T-MoCA score between 19 - 23 Exclusion Criteria: Potential participants are under the age of 65 years at the time of screening Scoring results in a range outside of 19-23 on the MoCA Those who have have a diagnosed illness or diagnosed injury which is known to directly and negatively impact cognition Are known (legally) to be deemed incapable; unable to appreciate information that is relevant to making decisions or is unable to appreciate the reasonably foreseeable consequences of either making or not making a decision.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tess Kroeker, PhD
    Phone
    7788778050
    Email
    Tess.Kroeker@kpu.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shaun Porter, MSc
    Phone
    1-833-414-8958
    Ext
    702
    Email
    sporter@abiwellness.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tess Kroeker, PhD
    Organizational Affiliation
    Kwantlen Polytechnic University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Shaun Porter, MSc
    Organizational Affiliation
    ABI Wellness Inc
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Maintaining Independence and Quality of Life in Aging Adults Through Targeted Cognitive Training

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