Health TrialsbyHealthPanel

Memory Support System Feasibility Study

ConditionMild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorBruyère Health Research Institute.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Memory Support System

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Memory Support System participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From study start date up to 19 months.

Secondary outcomes

1

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.

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.
2

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).

Time frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
3

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.

Time frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
4

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).

Time frame
Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bruyère Health Research Institute.

Lead sponsor

Ottawa Hospital Research Institute

Collaborator

Source ClinicalTrials.gov
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