French Memory Support System: A Pilot Study

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Memory Support System

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring cognition, french

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bruyere Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Memory Support System participants

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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.

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).

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).

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).

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).

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).

Full Information

NCT ID

NCT05253365

First Posted

January 4, 2022

Last Updated

August 3, 2023

Sponsor

Bruyere Research Institute

Collaborators

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05253365

Brief Title

French Memory Support System: A Pilot Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

March 3, 2022 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bruyere Research Institute

Collaborators

Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

cognition, french

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Memory Support System participants

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Memory Support System

Intervention Description

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 Outcome Measure Information:

Title

Adherence to French Memory Support System Intervention

Description

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 Outcome Measure Information:

Title

Center for Epidemiologic Studies Depression Scale

Description

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.

Title

Everyday Cognition questionnaire.

Description

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