French Memory Support System: A Pilot Study

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253365
• Other study ID #: M16-21-035
• Status: Completed
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2023
• Source: Bruyere Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Canada	Bruyere Research Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Bruyere Research Institute	Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.