French Memory Support System: A Pilot Study

NCT05253365 | Completed

• 1 other identifier: M16-21-035
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Mild Cognitive Impairment

Keywords

cognition; french

Outcome Measures

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.

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

Secondary Outcomes (7)

• Center for Epidemiologic Studies Depression Scale

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

• Everyday Cognition questionnaire.

  Baseline and at 8 week follow-up.

• Functional Assessment Questionnaire

  Baseline and at 8 week follow-up.

• Quality of Life in Alzheimer Disease

  Baseline and at 8 week follow-up.

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

  Baseline and at 8 week follow-up.

Study Arms (1)

Memory Support System participants

EXPERIMENTAL

Behavioral: Memory Support System

Interventions

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.

Memory Support System participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bruyère Health Research Institute.: lead
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Bruyere Research Institute

Ottawa, Ontario, K1H 5C8, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Neil W Thomas, MD

  Bruyère Health Research Institute.

  PRINCIPAL INVESTIGATOR

• Octavio Santos, PhD

  Ottawa Hospital Research Institute, Bruyere Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 23, 2022
• Study Start: March 3, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)