French Memory Support System: A Pilot Study
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Memory Support System participants
|
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Adherence to French Memory Support System Intervention [One week after starting the treatment (MSS intervention), treatment end, 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.
Secondary Outcome Measures
- Center for Epidemiologic Studies Depression Scale [Baseline, treatment end and at 8 week follow-up.]
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 and at 8 week follow-up.]
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.
- Functional Assessment Questionnaire [Baseline and at 8 week follow-up.]
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).
- Quality of Life in Alzheimer Disease [Baseline and at 8 week follow-up.]
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).
- State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project [Baseline and at 8 week follow-up.]
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).
- Chronic Disease Self-efficacy Scale [Baseline and at 8 week follow-up.]
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).
- Caregiver Burden Inventory Short-Form [Baseline and at 8 week follow-up.]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
diagnosis of single or multi-domain MCI
-
Clinical Dementia Rating global (CDR) score of ≤ 0.5
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Dementia Rating Scale-Second edition score of ≥ 115
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available contact with a care partner ≥ 2 times weekly
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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
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concurrent participation in another related clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bruyere Research Institute | Ottawa | Ontario | Canada | K1H 5C8 |
Sponsors and Collaborators
- Bruyere Research Institute
- Ottawa Hospital Research Institute
Investigators
- Principal Investigator: Neil W Thomas, MD, Bruyere Research Institute
- Principal Investigator: Octavio Santos, PhD, Ottawa Hospital Research Institute, Bruyere Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M16-21-035