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NCT Number: NCT05999929

Memory Support System 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

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Interest in completion of MSS training

    Time frame: From study start date up to 19 months.

    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 outcomes

  1. Adherence to French Memory Support System Intervention

    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.

    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.

  2. Center for Epidemiologic Studies Depression Scale

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

    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).

  3. Everyday Cognition questionnaire.

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

    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.

  4. Functional Assessment Questionnaire

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

    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).

  5. Quality of Life in Alzheimer Disease

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

    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).

  6. State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project

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

    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).

  7. Chronic Disease Self-efficacy Scale

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

    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).

  8. Caregiver Burden Inventory Short-Form

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Fjolla Berbatovci

CONTACT

[email protected]

613-562-6328

Neil Thomas, MD

CONTACT

[email protected]

613-562-6322

Sponsors and collaborators

Lead sponsor

Bruyère Health Research Institute.

Other

Collaborators

  • Ottawa Hospital Research Institute

Registry information

Official study title

Implementation of the Memory Support System: A Feasibility Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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