Memory Support System Feasibility Study

NCT05999929 | Recruiting

• 1 other identifier: M16-23-024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Conditions

Mild Cognitive Impairment

Keywords

Cognition; Intervention; French

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Adherence to French Memory Support System Intervention

  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

  Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

• Everyday Cognition questionnaire.

  Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

• Functional Assessment Questionnaire

  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

  Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

Study Arms (1)

Memory Support System participants

EXPERIMENTAL

Behavioral: Memory Support System

Interventions

Memory Support System BEHAVIORAL

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.

Memory Support System participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bruyère Health Research Institute.: lead
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Bruyère Health Research Institute

Ottawa, Ontario, K1H 5C8, Canada

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Neil Thomas, MD

  Bruyère Health Research Institute.

  PRINCIPAL INVESTIGATOR

• Octavio Santos, PhD

  Ottawa Hospital Research Institute, Bruyère Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Thomas, MD

CONTACT

613-562-6322; nthomas@bruyere.org

Fjolla Berbatovci

CONTACT

613-562-6328; fberbatovci@bruyere.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: December 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available after the end date of the study and kept indefinitely.
• Access Criteria: Upon request that is approved by the study principal investigators.

Locations

CA (1)