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Completed

NCT Number: NCT05253365

French Memory Support System: A Pilot Study

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

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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

Bruyere Research Institute

Ottawa, Ontario, K1H 5C8, Canada

About this study

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.

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
  • 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

  • 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. Adherence to French Memory Support System Intervention

    Time frame: One week after starting the treatment (MSS intervention), treatment end, 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.

Secondary outcomes

  1. Center for Epidemiologic Studies Depression Scale

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

    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).

  2. Everyday Cognition questionnaire.

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

    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.

  3. Functional Assessment Questionnaire

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

    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).

  4. Quality of Life in Alzheimer Disease

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

    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).

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

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

    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).

  6. Chronic Disease Self-efficacy Scale

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

    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).

  7. Caregiver Burden Inventory Short-Form

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

    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).

Sponsors and collaborators

Lead sponsor

Bruyère Health Research Institute.

Other

Collaborators

  • Ottawa Hospital Research Institute

Registry information

Official study title

French Memory Support System: A Pilot Study / Un Systeme de Support de Memoire en Francais: Une Etude de Faisabilite

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2022
Registry last updated
Aug 4, 2023

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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