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Haalbaarheidsstudie geheugenondersteuningssysteem

23 september 2026 bijgewerkt door: Bruyère Health Research Institute.

Implementatie van het geheugenondersteuningssysteem: een haalbaarheidsstudie

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 5C8
        • Werving
        • Bruyère Health Research Institute
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Memory Support System-deelnemers
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Interest in completion of MSS training
Tijdsspanne: From study start date up to 19 months.

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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adherence to French Memory Support System Intervention
Tijdsspanne: 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.

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.
Center for Epidemiologic Studies Depression Scale
Tijdsspanne: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

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.
Everyday Cognition questionnaire.
Tijdsspanne: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

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.
Functional Assessment Questionnaire
Tijdsspanne: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

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.
Quality of Life in Alzheimer Disease
Tijdsspanne: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

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.
State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
Tijdsspanne: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

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.
Chronic Disease Self-efficacy Scale
Tijdsspanne: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

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.
Caregiver Burden Inventory Short-Form
Tijdsspanne: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bruyère Health Research Institute.

Medewerkers

Ottawa Hospital Research Institute

Onderzoekers

  • Hoofdonderzoeker: Neil Thomas, MD, Bruyère Health Research Institute.
  • Hoofdonderzoeker: Octavio Santos, PhD, Ottawa Hospital Research Institute, Bruyère Health Research Institute

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 december 2023

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

30 april 2027

Studieregistratiedata

Eerst ingediend

3 augustus 2023

Eerst ingediend dat voldeed aan de QC-criteria

10 augustus 2023

Eerst geplaatst (Werkelijk)

21 augustus 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

23 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • M16-23-024

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified data from the study may be shared with other researchers within the HABIT consortium. Data that may be shared will include the results of the feasibility survey and the scores from the baseline, treatment end and 8 week follow up outcome measures collected from participants who complete MSS training.

IPD-tijdsbestek voor delen

Data will be available after the end date of the study and kept indefinitely.

IPD-toegangscriteria voor delen

Upon request that is approved by the study principal investigators.

IPD delen Ondersteunend informatietype

  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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