Memory ImpairmentNCT03244111
Examining the Effect of a Simple Memory Tool
A study testing simple memory tool in people with Memory Impairment, run by University of Manitoba at 1 site in Canada.
Trial summary
Objective: There have been a wide variety of interventions to assist with cognition and memory of older adults; however, it is often unclear if the interventions have an impact on daily life memory performance and goal attainment. Read more about this study
- Who is it for?
- Ages 55 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Impairment
- What is being tested?
- simple memory tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 1 Dec 2017
- 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 55 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy cognition
- high level of cognition as determined by MOCA scores
- lower level of cognition as determined by MOCA scores
- such as mild cognitive impairment (MCI)
Who cannot join
- If there is impairment that does not allow participants to perform intervention tasks on their own, then assistance may occur by a caregiver. As long as the participant is willing to be involved they can participate in the study. If participants are having too much difficulty they may wish to withdraw from study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba
Verena Menec, PhD, (204) 272-3184, Verena.Menec@umanitoba.ca
About this study
Objective: There have been a wide variety of interventions to assist with cognition and memory of older adults; however, it is often unclear if the interventions have an impact on daily life memory performance and goal attainment. The objectives of this study are to examine: 1) whether an intervention that involves a simple memory tool assists with daily life memory performance and goal attainment of older adults; and 2) whether the intervention has a different effect for individuals with healthy cognition versus individuals with mild cognitive impairment (MCI).
Research Questions: Can a simple memory tool assist with daily life memory performance and goal attainment for older adults? Does the simple memory tool have a different effect for individuals with healthy cognition and individuals with MCI? Methods: The study will use a mixed 2 X 3 design with cognition (healthy, MCI) as the between subjects factor and time (session 1, 2, 3) as the within-subjects factor. There will be 40 older adults who have healthy cognition and 20 older adults who have MCI. The study will consist of 3 sessions for each participant. The sessions will be held once a week and incorporate: a) the Montreal Cognitive Assessment (MOCA) to determine level of cognition (healthy, MCI); b) the Prospective and Retrospective Memory Questionnaire (PRMQ) to help determine daily memory performance; c) a memory recall test for recent daily events to help determine daily memory performance; d) the goals of the participants using the Goal Attainment Scaling (GAS); and e) the development of checklists that are tailored to address goals. In between the sessions, participants will perform the checklists and update the diary with notes of what they want to remember on a daily basis. The hypotheses are that: 1) memory performance (i.e., measured with memory recall of daily events and PRMQ), and goal attainment will increase from session to session; 2) participants with healthy cognition will have better memory performance and goal attainment than participants with MCI; and 3) participants with healthy cognition will have greater gains in memory performance and goal attainment than participants with MCI.
Read the detailed description
Method Participants The sample will consist of older adults (aged 55 or older). There will be 30 participants: 15 participants will have healthy cognition, and 15 participants will have MCI. The sample size was chosen in consideration to assumptions of robustness for repeated measures analysis of variance (ANOVA), and considerations to power (i.e., standard deviation and effect size from the pilot project). Participants will be recruited from the Centre on Aging participant database and the Alzheimer's Society of Manitoba. Individuals who are in the Centre on Aging participant database have given their consent to be contacted by researchers about their willingness to participate in specific research projects. The participants in the database have healthy cognition, and this should provide ample participants for the healthy cognition group for the study. The Centre on Aging participant database has been approved by the Health REB (REB #HS14652). The Alzheimer's Society of Manitoba will be also be contacted to recruit participants because they have contact information of potential participants who have cognitive impairments (i.e., MCI).
Procedure The study will consist of 3 sessions. The sessions will involve a participant meeting with the principal investigator individually for one hour sessions, either at the University of Manitoba (Bannatyne campus or Fort Garry campus), or if participants prefers, in his or her own home.
First session - Preliminary Procedures. During the first session, the principal investigator will describe the project, provide an informed consent form and answer any questions. Once the participant provides written consent, an interview will collect demographics (e.g., age, sex) and memory related information (e.g., difficulties, strategies).
First session - Memory and Goals. Memory assessments will be administered with the MOCA and PRMQ. The researcher will then interview the participant about the participant's memory difficulties and goals the participant has in regards to memory. The interview will be audiotaped and then the goals will be transcribed onto a goals form for the participant's record. A memory recall written test will also be performed that asks participants to list events that they were involved in during the previous week (i.e., the participant's may include events related to goals or any events that they may want to remember).
First session - Work Folder. The researcher and the participant will collaborate to create a daily checklist that the participant will use over the next week. The daily checklist will relate to goals of the participant.
Between Sessions. Between sessions, the participant will use the simple memory tool by using the work materials. The participant will perform tasks from a checklist each day. The participant will also use the pocket notebook to write down any events that they may want to remember (e.g., future tasks that they may want to put on checklists, diary entries that they may later want to transfer to the diary form).
Second Session. The second session will occur 7 days after the first session. Assessments for memory (i.e., memory recall test) and goals (i.e., GAS) will be performed again, similar to the first session. The MOCA will not be needed in the second session since participants have already been assigned to groups (i.e., healthy cognition or MCI). An additional step in the second session will involve goal assessment. The work folder will be updated with updated goals and checklists (i.e., similar to the first session) for the participant to use for the next 7 days.
Third Session. The third session will occur 7 days after the second session. Memory (i.e., PRMQ, memory recall test) and goals (i.e., GAS) will be assessed, similar to the second session. The third session will not include the step for updating work materials with new goals, as this is the last session. An additional step will be to administer a feedback questionnaire to gather feedback and suggestions from the participant on the study.
Tailored Intervention. The checklists are tailored individually to the goals of an individual. Since the intervention has elements that are unique for each individual, an example is included in the appendix to illustrate what the intervention might entail.
- Conditions
- Memory Impairment
- Being tested
- simple memory tool
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simple memory toolBehavioural
The goals may be implemented using the simple memory tool. Simple memory tool involves using materials such as checklists or diaries to assist with memory.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Cognition | Active comparator | The intervention will be carried out as described in the study details using the simple memory tool. The group with healthy cognition may perform better on tasks since they have a higher level of cognition. Receives: Behavioral: simple memory tool |
| MCI | Active comparator | The intervention will be carried out as described in the study details using the simple memory tool. The group with MCI may have a lower level of performance on tasks since they have a lower level of cognition. Some tasks may take longer for the participant or need more explanation from the researcher (e.g., explanation of a question). Receives: Behavioral: simple memory tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scaling (GAS) - Change from baseline to session 2 and 3
The GAS is a method for measuring goal attainment. It relies on self-report questions that ask if participants met their goals.
Measured: GAS is assessed during session 2 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.
Memory Recall Test - Change from sessions 1, 2 and 3
Participants are asked to recall events that occurred last week (i.e., between sessions with the researcher)
Measured: Memory recall is assessed during session 1, 2 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.
Prospective and Retrospective Memory Questionnaire (PRMQ) - Change from session 1 to 3
PRMQ is a questionnaire about daily memory difficulties
Measured: PRMQ is assessed during session 1 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Jun 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The MOCA is a one page test that assesses cognition. The MOCA will be administered and participants with total scores \<= 25 will be in the lower cognition group, whereas participants with total scores \> 25 will be in the higher cognition group. These are recommended cut off scores to detect mild cognitive impairment (MCI).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Saltel, University of Manitoba
- Investigators
- Verena Menec, PhD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244111
- Sponsor's protocol ID
- H2017:105
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There has been discussion that there may be a follow up study, in which case participant data may be used.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of a Simple Memory Tool
- ClinicalTrials.gov ID
- NCT03244111
- Acronym / sponsor ID
- H2017:105
- Conditions
- Memory Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 9 Aug 2017 (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.
Objective: There have been a wide variety of interventions to assist with cognition and memory of older adults; however, it is often unclear if the interventions have an impact on daily life memory performance and goal attainment. The objectives of this study are to examine: 1) whether an intervention that involves a simple memory tool assists with daily life memory performance and goal attainment of older adults; and 2) whether the intervention has a different effect for individuals with healthy cognition versus individuals with mild cognitive impairment (MCI).
Research Questions: Can a simple memory tool assist with daily life memory performance and goal attainment for older adults? Does the simple memory tool have a different effect for individuals with healthy cognition and individuals with MCI? Methods: The study will use a mixed 2 X 3 design with cognition (healthy, MCI) as the between subjects factor and time (session 1, 2, 3) as the within-subjects factor. There will be 40 older adults who have healthy cognition and 20 older adults who have MCI. The study will consist of 3 sessions for each participant. The sessions will be held once a week and incorporate: a) the Montreal Cognitive Assessment (MOCA) to determine level of cognition (healthy, MCI); b) the Prospective and Retrospective Memory Questionnaire (PRMQ) to help determine daily memory performance; c) a memory recall test for recent daily events to help determine daily memory performance; d) the goals of the participants using the Goal Attainment Scaling (GAS); and e) the development of checklists that are tailored to address goals. In between the sessions, participants will perform the checklists and update the diary with notes of what they want to remember on a daily basis. The hypotheses are that: 1) memory performance (i.e., measured with memory recall of daily events and PRMQ), and goal attainment will increase from session to session; 2) participants with healthy cognition will have better memory performance and goal attainment than participants with MCI; and 3) participants with healthy cognition will have greater gains in memory performance and goal attainment than participants with MCI.
Detailed description
Method Participants The sample will consist of older adults (aged 55 or older). There will be 30 participants: 15 participants will have healthy cognition, and 15 participants will have MCI. The sample size was chosen in consideration to assumptions of robustness for repeated measures analysis of variance (ANOVA), and considerations to power (i.e., standard deviation and effect size from the pilot project). Participants will be recruited from the Centre on Aging participant database and the Alzheimer's Society of Manitoba. Individuals who are in the Centre on Aging participant database have given their consent to be contacted by researchers about their willingness to participate in specific research projects. The participants in the database have healthy cognition, and this should provide ample participants for the healthy cognition group for the study. The Centre on Aging participant database has been approved by the Health REB (REB #HS14652). The Alzheimer's Society of Manitoba will be also be contacted to recruit participants because they have contact information of potential participants who have cognitive impairments (i.e., MCI).
Procedure The study will consist of 3 sessions. The sessions will involve a participant meeting with the principal investigator individually for one hour sessions, either at the University of Manitoba (Bannatyne campus or Fort Garry campus), or if participants prefers, in his or her own home.
First session - Preliminary Procedures. During the first session, the principal investigator will describe the project, provide an informed consent form and answer any questions. Once the participant provides written consent, an interview will collect demographics (e.g., age, sex) and memory related information (e.g., difficulties, strategies).
First session - Memory and Goals. Memory assessments will be administered with the MOCA and PRMQ. The researcher will then interview the participant about the participant's memory difficulties and goals the participant has in regards to memory. The interview will be audiotaped and then the goals will be transcribed onto a goals form for the participant's record. A memory recall written test will also be performed that asks participants to list events that they were involved in during the previous week (i.e., the participant's may include events related to goals or any events that they may want to remember).
First session - Work Folder. The researcher and the participant will collaborate to create a daily checklist that the participant will use over the next week. The daily checklist will relate to goals of the participant.
Between Sessions. Between sessions, the participant will use the simple memory tool by using the work materials. The participant will perform tasks from a checklist each day. The participant will also use the pocket notebook to write down any events that they may want to remember (e.g., future tasks that they may want to put on checklists, diary entries that they may later want to transfer to the diary form).
Second Session. The second session will occur 7 days after the first session. Assessments for memory (i.e., memory recall test) and goals (i.e., GAS) will be performed again, similar to the first session. The MOCA will not be needed in the second session since participants have already been assigned to groups (i.e., healthy cognition or MCI). An additional step in the second session will involve goal assessment. The work folder will be updated with updated goals and checklists (i.e., similar to the first session) for the participant to use for the next 7 days.
Third Session. The third session will occur 7 days after the second session. Memory (i.e., PRMQ, memory recall test) and goals (i.e., GAS) will be assessed, similar to the second session. The third session will not include the step for updating work materials with new goals, as this is the last session. An additional step will be to administer a feedback questionnaire to gather feedback and suggestions from the participant on the study.
Tailored Intervention. The checklists are tailored individually to the goals of an individual. Since the intervention has elements that are unique for each individual, an example is included in the appendix to illustrate what the intervention might entail.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The MOCA is a one page test that assesses cognition. The MOCA will be administered and participants with total scores <= 25 will be in the lower cognition group, whereas participants with total scores > 25 will be in the higher cognition group. These are recommended cut off scores to detect mild cognitive impairment (MCI).
| Arm | Type | Receives |
|---|---|---|
| Healthy Cognition | Active comparator | Behavioral: simple memory toolThe intervention will be carried out as described in the study details using the simple memory tool. The group with healthy cognition may perform better on tasks since they have a higher level of cognition. |
| MCI | Active comparator | Behavioral: simple memory toolThe intervention will be carried out as described in the study details using the simple memory tool. The group with MCI may have a lower level of performance on tasks since they have a lower level of cognition. Some tasks may take longer for the participant or need more explanation from the researcher (e.g., explanation of a question). |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- healthy cognition
- lower level of cognition as determined by MOCA scores
Key exclusion criteria (1 listed)
- If there is impairment that does not allow participants to perform intervention tasks on their own, then assistance may occur by a caregiver. As long as the participant is willing to be involved they can participate in the study. If participants are having too much difficulty they may wish to withdraw from study.
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 |
|---|---|---|
| simple memory toolThe goals may be implemented using the simple memory tool. Simple memory tool involves using materials such as checklists or diaries to assist with memory. | Behavioural | Healthy Cognition, MCI |
Primary outcome
Goal Attainment Scaling (GAS) - Change from baseline to session 2 and 3
Time frame: GAS is assessed during session 2 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.
The GAS is a method for measuring goal attainment. It relies on self-report questions that ask if participants met their goals.
Memory Recall Test - Change from sessions 1, 2 and 3
Time frame: Memory recall is assessed during session 1, 2 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.
Participants are asked to recall events that occurred last week (i.e., between sessions with the researcher)
Prospective and Retrospective Memory Questionnaire (PRMQ) - Change from session 1 to 3
Time frame: PRMQ is assessed during session 1 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.
PRMQ is a questionnaire about daily memory difficulties
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: Undecided. There has been discussion that there may be a follow up study, in which case participant data may be used.
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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.
Verena Menec, PhD study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simple memory tool in people with Memory Impairment, run by University of Manitoba 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Saltel (204-257-7145, umsalt23@myumanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling (GAS) - Change from baseline to session 2 and 3 (time frame: GAS is assessed during session 2 and 3 with the researcher. I.e., Session 1 is the first time the researcher meets with participant, session 2 occurs one week after session 1, session 3 occurs once week after session 2.). The study lists 3 primary outcomes in all. 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 9 Aug 2017.