Clinical trial NCT05999929: Memory Support System Feasibility Study
Official title: Implementation of the Memory Support System: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Cognition
Intervention
French
Lead sponsor: Bruyere Research Institute
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
First posted: 2023-08-21
Enrollment: 40
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 determining the feasibility of providing the Memory Support System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a clinic in Ontario, Canada. This will involve a) collecting information from patients referred to the a memory clinic and geriatric day hospital about the patient's interest in and the patient's preferred method to administer the MSS; and b) a cost analysis related to implementation of the MSS. The study will also measure efficacy outcomes of the MSS regarding program adherence as well as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden among a sample of individuals with MCI and their care partners

Detailed description: A survey will be created and sent out to participants with MCI who have expressed interest in participating in research and have been seen at a memory clinic or geriatric day hospital after the initiation of the study. The survey will consist of a Likert scale and open questions related to patient interest in and preferred length of MSS administration and preference for in-person versus virtual administration.

During and after collection of the survey data, a sample of 20 individuals with MCI (ages ≥50) and their care partners will undergo MSS training.

At enrollment in the MSS training, participants with MCI and their care partners will complete measures of cognitive and functional status. Participants and partners will also complete measures of treatment adherence, IADLs, 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. Training will be offered in English or French. After the intervention, participants and their partners will complete a semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum, and intervention logistics.

Eligibility criteria: Inclusion Criteria:

* diagnosis of single or multi-domain MCI
* Clinical Dementia Rating global (CDR) score of ≤ 0.5
* Montreal Cognitive Assessment score of ≥18
* 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: Interest in completion of MSS training
timeFrame: From study start date up to 19 months.
Secondary outcomes:
measure: Adherence to French Memory Support System Intervention
timeFrame: One week after starting the treatment (MSS intervention), at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
measure: Everyday Cognition questionnaire.
timeFrame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
measure: Functional Assessment Questionnaire
timeFrame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
measure: Quality of Life in Alzheimer Disease
timeFrame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
measure: State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
timeFrame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
measure: Chronic Disease Self-efficacy Scale
timeFrame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
measure: Caregiver Burden Inventory Short-Form
timeFrame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Bruyere Research Institute
state: Ontario
Study officials:
affiliation: Bruyere Research Institute
name: Neil Thomas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute, Bruyere Research Institute
name: Octavio Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References: