French Memory Support System: A Pilot Study

Study Overview
=================
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.

Official Title
-----------------
French Memory Support System: A Pilot Study / Un Systeme de Support de Memoire en Francais: Une Etude de Faisabilite

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Behavioral: Memory Support System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary 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), treatment end, and at 8 week follow-up after treatment end. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, treatment end and at 8 week follow-up. | 
| 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 and at 8 week follow-up. | 
| 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 and at 8 week follow-up. | 
| 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 and at 8 week follow-up. | 
| 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 and at 8 week follow-up. | 
| 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 and at 8 week follow-up. | 
| 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 and at 8 week follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition, french