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Recruiting NCT05999929

Memory Support System Feasibility Study

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Memory Support System.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Implementation of the Memory Support System: A Feasibility Study

Overview

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 the patient's interest in and the patient's 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

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.

Interventions

  • 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.

Primary outcome measures

  • Interest in completion of MSS training [Time frame: From study start date up to 19 months.]
Secondary outcome measures (8)
  • Adherence to French Memory Support System Intervention [Time frame: 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 [Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Everyday Cognition questionnaire. [Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Functional Assessment Questionnaire [Time frame: 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 [Time frame: 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 [Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Chronic Disease Self-efficacy Scale [Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]
  • Caregiver Burden Inventory Short-Form [Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • Bruyère Health Research Institute — Ottawa

Identifiers

NCT: NCT05999929 · M16-23-024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗