French Memory Support System: A Pilot Study

NCT ID: NCT05253365

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2023-03-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Memory Support System participants

Group Type: EXPERIMENTAL

Memory Support System

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

Bruyère Health Research Institute.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil W Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Bruyère Health Research Institute.

Octavio Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute, Bruyere Research Institute

Locations

Bruyere Research Institute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

M16-21-035

Identifier Type: -

Identifier Source: org_study_id