Memory Support System Feasibility Study

NCT ID: NCT05999929

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-17
• Study Completion Date: 2026-04-30

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

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Memory Support System participants

Group Type: EXPERIMENTAL

Memory Support System

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

Bruyère Health Research Institute.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Bruyère Health Research Institute.

Octavio Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute, Bruyère Health Research Institute

Locations

Bruyère Health Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Neil Thomas, MD

Role: CONTACT

nthomas@bruyere.org

613-562-6322

Fjolla Berbatovci

Role: CONTACT

fberbatovci@bruyere.org

613-562-6328

Facility Contacts

Fjolla Berbatovci

Role: primary

FBerbatovci@bruyere.org

613-562-6262 ext. 1236

Neil Thomas, MD

Role: backup

nthomas@bruyere.org

613-562-6322

Other Identifiers

M16-23-024

Identifier Type: -

Identifier Source: org_study_id