Memory Support System Feasibility Study

Mild Cognitive Impairment Clinical Trial

Official title:

Implementation of the Memory Support System: A Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05999929
• Other study ID #: M16-23-024
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Bruyere Research Institute
• Contact: Neil Thomas, MD
• Phone: 613-562-6262
• Email: nthomas[@]bruyere.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Canada	Bruyere Research Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Bruyere Research Institute	Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.