Memory Support System Feasibility Study

Implementation of the Memory Support System: A Feasibility Study

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 the patient's interest in and the patient's 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

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Memory Support System

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neil Thomas, MD; Phone Number: 613-562-6322; Email: nthomas@bruyere.org
• Study Contact Backup: Name: Fjolla Berbatovci; Phone Number: 613-562-6328; Email: fberbatovci@bruyere.org

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 5C8
      • Recruiting
      • Bruyère Health Research Institute
      • Contact: Neil Thomas, MD; Phone Number: 613-562-6322; Email: nthomas@bruyere.org
      • Contact: Fjolla Berbatovci; Phone Number: 1236 613-562-6262; Email: FBerbatovci@bruyere.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Memory Support System participants	Behavioral: Memory Support System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From study start date up to 19 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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).	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
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.	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
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).	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
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).	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
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).	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
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).	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
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).	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

Collaborators and Investigators

• Sponsor: Bruyère Health Research Institute.
• Collaborators: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Neil Thomas, MD, Bruyère Health Research Institute.; Principal Investigator: Octavio Santos, PhD, Ottawa Hospital Research Institute, Bruyère Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cognition; Intervention; French
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: M16-23-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No