Mild Cognitive ImpairmentNCT05253365
French Memory Support System: A Pilot Study
A study testing Memory Support System in people with Mild Cognitive Impairment, run by Bruyère Health Research Institute. at 1 site in Canada.
Trial summary
The purpose of this study is to develop a linguistically and culturally appropriate adaptation of the Memory Support System (MSS), an evidence-based intervention to train persons with mild cognitive impairment (MCI) to complete personal goals and instrumental activities of daily living independently. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Memory Support System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 3 Mar 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of single or multi-domain MCI
- Clinical Dementia Rating global (CDR) score of ≤ 0.5
- Dementia Rating Scale-Second edition score of ≥ 115
- available contact with a care partner ≥ 2 times weekly
- absence or stable intake of nootropic(s) for ≥ 3 months
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: French Memory Support System: A Pilot Study / Un Systeme de Support de Memoire en Francais: Une Etude de Faisabilite
The purpose of this study is to develop a linguistically and culturally appropriate adaptation of the Memory Support System (MSS), an evidence-based intervention to train persons with mild cognitive impairment (MCI) to complete personal goals and instrumental activities of daily living independently. The study will involve development of the associated manual, training and patient forms, and outcome measures, and pilot testing of the intervention in a group of French-speaking individuals with MCI and their care partners
Read the detailed description
At enrollment, participants with MCI and their care partners will complete French measures evaluating cognitive and functional status. Participants and partners will also complete French measures of treatment adherence, instrumental activities of daily living, 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Memory Support System
- Keywords
- cognition, french
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Support SystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Memory Support System participants | Experimental | Not described Receives: Behavioral: Memory Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week after starting the treatment (MSS intervention), treatment end, and at 8 week follow-up after treatment end.
Secondary outcomes (7)
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).
Measured: Baseline, treatment end and at 8 week follow-up.
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.
Measured: Baseline and at 8 week follow-up.
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).
Measured: Baseline and at 8 week follow-up.
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).
Measured: Baseline and at 8 week follow-up.
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).
Measured: Baseline and at 8 week follow-up.
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).
Measured: Baseline and at 8 week follow-up.
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).
Measured: Baseline and at 8 week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start3 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Neil W Thomas, MD, Principal investigator, Bruyère Health Research Institute.Octavio Santos, PhD, Principal investigator, Ottawa Hospital Research Institute, Bruyere Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253365
- Sponsor's protocol ID
- M16-21-035
- Status last verified
- Aug 2023
- First submitted
- 4 Jan 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Memory Support System: A Pilot Study / Un Systeme de Support de Memoire en Francais: Une Etude de Faisabilite
- ClinicalTrials.gov ID
- NCT05253365
- Acronym / sponsor ID
- M16-21-035
- Conditions
- Mild Cognitive Impairment
- Keywords
- cognition, french
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a linguistically and culturally appropriate adaptation of the Memory Support System (MSS), an evidence-based intervention to train persons with mild cognitive impairment (MCI) to complete personal goals and instrumental activities of daily living independently. The study will involve development of the associated manual, training and patient forms, and outcome measures, and pilot testing of the intervention in a group of French-speaking individuals with MCI and their care partners
Detailed description
At enrollment, participants with MCI and their care partners will complete French measures evaluating cognitive and functional status. Participants and partners will also complete French measures of treatment adherence, instrumental activities of daily living, 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory Support System participants | Experimental | Behavioral: Memory Support System |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of single or multi-domain MCI
- Clinical Dementia Rating global (CDR) score of ≤ 0.5
- Dementia Rating Scale-Second edition score of ≥ 115
- available contact with a care partner ≥ 2 times weekly
- absence or stable intake of nootropic(s) for ≥ 3 months
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory Support SystemThe 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. | Behavioural | Memory Support System participants |
Primary outcome
Adherence to French Memory Support System Intervention
Time frame: One week after starting the treatment (MSS intervention), treatment end, 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.
7 secondary outcomes
Center for Epidemiologic Studies Depression Scale
Time frame: Baseline, treatment end and at 8 week follow-up.
Everyday Cognition questionnaire.
Time frame: Baseline and at 8 week follow-up.
Functional Assessment Questionnaire
Time frame: Baseline and at 8 week follow-up.
Quality of Life in Alzheimer Disease
Time frame: Baseline and at 8 week follow-up.
State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
Time frame: Baseline and at 8 week follow-up.
Chronic Disease Self-efficacy Scale
Time frame: Baseline and at 8 week follow-up.
Caregiver Burden Inventory Short-Form
Time frame: Baseline and at 8 week follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil W Thomas, MD principal investigator
Bruyère Health Research Institute.
Octavio Santos, PhD principal investigator
Ottawa Hospital Research Institute, Bruyere Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Support System in people with Mild Cognitive Impairment, run by Bruyère Health Research Institute. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to French Memory Support System Intervention (time frame: One week after starting the treatment (MSS intervention), treatment end, and at 8 week follow-up after treatment end.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.