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CompletedNCT05253365Updated Aug 4, 2023

French Memory Support System: A Pilot Study

An interventional study of Memory Support System in Mild Cognitive Impairment, sponsored by Bruyere Research Institute. Completed at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Bruyere Research Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

The purpose of this study is to develop a linguistically and culturally appropriate adaptation of the Memory Support System (MSS), an evidence-based intervention to train persons with mild cognitive impairment (MCI) to complete personal goals and instrumental activities of daily living independently. The study will involve development of the associated manual, training and patient forms, and outcome measures, and pilot testing of the intervention in a group of French-speaking individuals with MCI and their care partners

Read the detailed description

At enrollment, participants with MCI and their care partners will complete French measures evaluating cognitive and functional status. Participants and partners will also complete French measures of treatment adherence, instrumental activities of daily living, 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.

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Conditions studied

  • Mild Cognitive Impairment

Keywords

  • cognition
  • french
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In context

Cognitive Dysfunction

3,845 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 10 is below the median of 64 across 2,810 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Bruyere Research Institute is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of single or multi-domain MCI
  • Clinical Dementia Rating global (CDR) score of ≤ 0.5
  • Dementia Rating Scale-Second edition score of ≥ 115
  • available contact with a care partner ≥ 2 times weekly
  • absence or stable intake of nootropic(s) for ≥ 3 months

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Memory Support System participants

    Behavioral: Memory Support System

Interventions

  • BehavioralMemory 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: One week after starting the treatment (MSS intervention), treatment end, and at 8 week follow-up after treatment end.

Secondary outcomes

  1. 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).

    Time frame: Baseline, treatment end and at 8 week follow-up.

  2. 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.

    Time frame: Baseline and at 8 week follow-up.

  3. 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).

    Time frame: Baseline and at 8 week follow-up.

  4. 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).

    Time frame: Baseline and at 8 week follow-up.

  5. 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).

    Time frame: Baseline and at 8 week follow-up.

  6. 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).

    Time frame: Baseline and at 8 week follow-up.

  7. 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).

    Time frame: Baseline and at 8 week follow-up.

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Study locations

1 site
  • Bruyere Research Institute
    Ottawa, Ontario K1H 5C8, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05253365
Lead sponsor
Bruyere Research Institute
Collaborators
Ottawa Hospital Research Institute
Responsible party
Sponsor
First posted
Feb 23, 2022
Start date
Mar 3, 2022
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Aug 4, 2023

Study contacts

Neil W Thomas, MD
principal investigator · Bruyere Research Institute
Octavio Santos, PhD
principal investigator · Ottawa Hospital Research Institute, Bruyere Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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