Clinical trial NCT05253365: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: cognition
french
Lead sponsor: Bruyere Research Institute
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
First posted: 2022-02-23
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Adherence to French Memory Support System Intervention
timeFrame: One week after starting the treatment (MSS intervention), treatment end, and at 8 week follow-up after treatment end.
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline, treatment end and at 8 week follow-up.
measure: Everyday Cognition questionnaire.
timeFrame: Baseline and at 8 week follow-up.
measure: Functional Assessment Questionnaire
timeFrame: Baseline and at 8 week follow-up.
measure: Quality of Life in Alzheimer Disease
timeFrame: Baseline and at 8 week follow-up.
measure: State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
timeFrame: Baseline and at 8 week follow-up.
measure: Chronic Disease Self-efficacy Scale
timeFrame: Baseline and at 8 week follow-up.
measure: Caregiver Burden Inventory Short-Form
timeFrame: Baseline and at 8 week follow-up.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Bruyere Research Institute
state: Ontario
Study officials:
affiliation: Bruyere Research Institute
name: Neil W Thomas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute, Bruyere Research Institute
name: Octavio Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References: