Skip to main content
Clinical Trials/NCT05253365
NCT05253365
Completed
Not Applicable

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

Bruyere Research Institute1 site in 1 country10 target enrollmentMarch 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Bruyere Research Institute
Enrollment
10
Locations
1
Primary Endpoint
Adherence to French Memory Support System Intervention
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2022
End Date
March 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Bruyere Research Institute
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Adherence to French Memory Support System Intervention

Time Frame: 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 Outcomes

  • Everyday Cognition questionnaire.(Baseline and at 8 week follow-up.)
  • Center for Epidemiologic Studies Depression Scale(Baseline, treatment end and at 8 week follow-up.)
  • Functional Assessment Questionnaire(Baseline and at 8 week follow-up.)
  • Quality of Life in Alzheimer Disease(Baseline and at 8 week follow-up.)
  • State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project(Baseline and at 8 week follow-up.)
  • Chronic Disease Self-efficacy Scale(Baseline and at 8 week follow-up.)
  • Caregiver Burden Inventory Short-Form(Baseline and at 8 week follow-up.)

Study Sites (1)

Loading locations...

Similar Trials