Memory Support System Feasibility Study

Study Overview
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Brief Summary
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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 their interest in and their 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
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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.

Official Title
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Implementation of the Memory Support System: A Feasibility Study

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Memory Support System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memory Support System participants<br> | Behavioral: Memory Support System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Intervention, French