Memory Support System Feasibility Study
Primary Purpose
Mild Cognitive Impairment
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Memory Support System
Sponsored by

About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Cognition, Intervention, French
Eligibility Criteria
Inclusion Criteria: diagnosis of single or multi-domain MCI Clinical Dementia Rating global (CDR) score of ≤ 0.5 Montreal Cognitive Assessment score of ≥18 available contact with a care partner ≥ 2 times weekly absence or stable intake of nootropic(s) for ≥ 3 months Exclusion Criteria: visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training concurrent participation in another related clinical trial
Sites / Locations
- Bruyere Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Memory Support System participants
Arm Description
Outcomes
Primary Outcome Measures
Interest in completion of MSS training
Percentage of participants that complete the feasibility survey and agree or strongly agree with the statement that they are interested in completing MSS training.
Secondary Outcome Measures
Adherence to French Memory Support System Intervention
Change from adherence scores from one week after starting treatment (MSS intervention) at treatment end and at 8 weeks after the treatment end. Using an adherence scale from 0 to 10, with 10 being highest and a cut-off score of ≥ 7 points suggesting adherence with the MSS.
Center for Epidemiologic Studies Depression Scale
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Depression screening scale using Likert scale. Total score of 0-60 points, with higher scores signifying a worse outcome (higher levels of depression).
Everyday Cognition questionnaire.
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report measure of performance based instrumental activities of daily living. Total score of 23-92, with higher scores indicating a worse outcome.
Functional Assessment Questionnaire
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based report of performance of instrumental activities of daily living. Total score of 0-30, with higher scores indicating a worse outcome (higher level of dependence).
Quality of Life in Alzheimer Disease
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report quality of life scale. Total score of 13-52, with higher scores indicating a better outcome (better quality of life).
State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report anxiety scale. Total score of 10-40 with higher scores indicating a worse outcome (higher level of anxiety).
Chronic Disease Self-efficacy Scale
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Selected questions related to memory and cognition from self report scale. Total score of 9-90 with higher scores indicating a better outcomes (higher feeling of self-efficacy).
Caregiver Burden Inventory Short-Form
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based scale of level of caregiver burden. Total score of 0-48 with higher scores indicating a worse outcome (higher level of burden).
Full Information
NCT ID
NCT05999929
First Posted
August 3, 2023
Last Updated
August 10, 2023
Sponsor
Bruyere Research Institute
Collaborators
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05999929
Brief Title
Memory Support System Feasibility Study
Official Title
Implementation of the Memory Support System: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bruyere Research Institute
Collaborators
Ottawa Hospital Research Institute
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
The purpose of this study is to determining the feasibility of providing the Memory Support System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a clinic in Ontario, Canada. This will involve a) collecting information from patients referred to the a memory clinic and geriatric day hospital about their interest in and their preferred method to administer the MSS; and b) a cost analysis related to implementation of the MSS. The study will also measure efficacy outcomes of the MSS regarding program adherence as well as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden among a sample of individuals with MCI and their care partners
Detailed Description
A survey will be created and sent out to participants with MCI who have expressed interest in participating in research and have been seen at a memory clinic or geriatric day hospital after the initiation of the study. The survey will consist of a Likert scale and open questions related to patient interest in and preferred length of MSS administration and preference for in-person versus virtual administration.
During and after collection of the survey data, a sample of 20 individuals with MCI (ages ≥50) and their care partners will undergo MSS training.
At enrollment in the MSS training, participants with MCI and their care partners will complete measures of cognitive and functional status. Participants and partners will also complete measures of treatment adherence, IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. Participants will complete the MSS training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment. Training will be offered in English or French. After the intervention, participants and their partners will complete a semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum, and intervention logistics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Cognition, Intervention, French
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Memory Support System participants
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Memory Support System
Intervention Description
The MSS is a two-page-per-day, pocket-sized calendar/note-taking system with three sections: (a) events; (b) to do's; and (c) journaling for logging important things to be remembered (e.g., news about family/friends). MSS training consists of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after baseline assessment.
Primary Outcome Measure Information:
Title
Interest in completion of MSS training
Description
Percentage of participants that complete the feasibility survey and agree or strongly agree with the statement that they are interested in completing MSS training.
Time Frame
From study start date up to 19 months.
Secondary Outcome Measure Information:
Title
Adherence to French Memory Support System Intervention
Description
Change from adherence scores from one week after starting treatment (MSS intervention) at treatment end and at 8 weeks after the treatment end. Using an adherence scale from 0 to 10, with 10 being highest and a cut-off score of ≥ 7 points suggesting adherence with the MSS.
Time Frame
One week after starting the treatment (MSS intervention), at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Title
Center for Epidemiologic Studies Depression Scale
Description
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Depression screening scale using Likert scale. Total score of 0-60 points, with higher scores signifying a worse outcome (higher levels of depression).
Time Frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Title
Everyday Cognition questionnaire.
Description
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report measure of performance based instrumental activities of daily living. Total score of 23-92, with higher scores indicating a worse outcome.
Time Frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Title
Functional Assessment Questionnaire
Description
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based report of performance of instrumental activities of daily living. Total score of 0-30, with higher scores indicating a worse outcome (higher level of dependence).
Time Frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Title
Quality of Life in Alzheimer Disease
Description
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report quality of life scale. Total score of 13-52, with higher scores indicating a better outcome (better quality of life).
Time Frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Title
State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
Description
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report anxiety scale. Total score of 10-40 with higher scores indicating a worse outcome (higher level of anxiety).
Time Frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Title
Chronic Disease Self-efficacy Scale
Description
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Selected questions related to memory and cognition from self report scale. Total score of 9-90 with higher scores indicating a better outcomes (higher feeling of self-efficacy).
Time Frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Title
Caregiver Burden Inventory Short-Form
Description
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based scale of level of caregiver burden. Total score of 0-48 with higher scores indicating a worse outcome (higher level of burden).
Time Frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of single or multi-domain MCI
Clinical Dementia Rating global (CDR) score of ≤ 0.5
Montreal Cognitive Assessment score of ≥18
available contact with a care partner ≥ 2 times weekly
absence or stable intake of nootropic(s) for ≥ 3 months
Exclusion Criteria:
visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training
concurrent participation in another related clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Thomas, MD
Phone
613-562-6262
Ext
4071
Email
nthomas@bruyere.org
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Fievre
Phone
613-562-6262
Ext
1290
Email
JFievre@bruyere.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Thomas, MD
Organizational Affiliation
Bruyere Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Octavio Santos, PhD
Organizational Affiliation
Ottawa Hospital Research Institute, Bruyere Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bruyere Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 5C8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Fievre
Phone
613-562-6262
Ext
1290
Email
nthomas@bruyere.org
First Name & Middle Initial & Last Name & Degree
Neil Thomas, MD
Phone
613-562-6262
Ext
4071
Email
JFievre@bruyere.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data from the study may be shared with other researchers within the HABIT consortium. Data that may be shared will include the results of the feasibility survey and the scores from the baseline, treatment end and 8 week follow up outcome measures collected from participants who complete MSS training.
IPD Sharing Time Frame
Data will be available after the end date of the study and kept indefinitely.
IPD Sharing Access Criteria
Upon request that is approved by the study principal investigators.
Learn more about this trial
Memory Support System Feasibility Study
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