Memory Support System Feasibility Study

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Memory Support System

• Registration Number: NCT05999929
• Lead Sponsor: Bruyere Research Institute

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.

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-10
• Study First Posted: 2023-08-21
• Study Start: 2023-12-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Memory Support System participants	Memory Support System	-

Primary Outcome Measures

Name	Time	Method
Interest in completion of MSS training	From study start date up to 19 months.	Percentage of participants that complete the feasibility survey and agree or strongly agree with the statement that they are interested in completing MSS training.

Secondary Outcome Measures

Name	Time	Method
Center for Epidemiologic Studies Depression Scale	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.	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).
Everyday Cognition questionnaire.	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.	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.
Quality of Life in Alzheimer Disease	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.	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).
Functional Assessment Questionnaire	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.	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).
Adherence to French Memory Support System Intervention	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.	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.
Chronic Disease Self-efficacy Scale	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.	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).
State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.	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).
Caregiver Burden Inventory Short-Form	Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.	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).

Trial Locations

Locations (1)

Bruyere Research Institute; 🇨🇦 Ottawa, Ontario, Canada