Memóriatámogatási rendszer megvalósíthatósági tanulmánya
A memóriatámogató rendszer megvalósítása: megvalósíthatósági tanulmány
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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Neil Thomas, MD
- Telefonszám: 613-562-6322
- E-mail: nthomas@bruyere.org
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Nayna Kirubakar
- Telefonszám: 1266 613-562-6262
- E-mail: nkirubakar@bruyere.org
Tanulmányi helyek
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-
Ontario
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Ottawa, Ontario, Kanada, K1H 5C8
- Toborzás
- Bruyère Health Research Institute
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Kapcsolatba lépni:
- Neil Thomas, MD
- Telefonszám: 613-562-6322
- E-mail: nthomas@bruyere.org
-
Kapcsolatba lépni:
- Nayna Kirubakar
- Telefonszám: 1266 613-562-6262
- E-mail: nkirubakar@bruyere.org
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: A memóriatámogató rendszer résztvevői
|
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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Interest in completion of MSS training
Időkeret: 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.
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Adherence to French Memory Support System Intervention
Időkeret: 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
Időkeret: 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.
Időkeret: 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.
|
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Functional Assessment Questionnaire
Időkeret: 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.
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Quality of Life in Alzheimer Disease
Időkeret: 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.
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State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
Időkeret: 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.
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Chronic Disease Self-efficacy Scale
Időkeret: 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.
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Caregiver Burden Inventory Short-Form
Időkeret: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
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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.
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Neil Thomas, MD, Bruyère Health Research Institute.
- Kutatásvezető: Octavio Santos, PhD, Ottawa Hospital Research Institute, Bruyère Health Research Institute
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- M16-23-024
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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 megosztási időkeret
Data will be available after the end date of the study and kept indefinitely.
IPD-megosztási hozzáférési feltételek
Upon request that is approved by the study principal investigators.
Az IPD megosztását támogató információ típusa
- CSR
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