French Memory Support System: A Pilot Study

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

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

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Memory Support System

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 5C8
      • Bruyere Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Memory Support System participants	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One week after starting the treatment (MSS intervention), treatment end, and at 8 week follow-up after treatment end.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, treatment end and at 8 week follow-up.
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.	Baseline and at 8 week follow-up.
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).	Baseline and at 8 week follow-up.
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).	Baseline and at 8 week follow-up.
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).	Baseline and at 8 week follow-up.
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).	Baseline and at 8 week follow-up.
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).	Baseline and at 8 week follow-up.

Collaborators and Investigators

• Sponsor: Bruyere Research Institute
• Collaborators: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Neil W Thomas, MD, Bruyere Research Institute; Principal Investigator: Octavio Santos, PhD, Ottawa Hospital Research Institute, Bruyere Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: cognition; french
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: M16-21-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No