Subjective Cognitive DeclineNCT03495037
Preventing Cognitive and Functional Decline Among Seniors at Risk
A study testing Real World Strategy Training and Psychosocial Education in people with Subjective Cognitive Decline, run by Baycrest at 1 site in Canada.
Trial summary
This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of these approaches. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- Real World Strategy Training and Psychosocial Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2017to 30 Mar 2021
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have subjective cognitive complaints
- Be fluent in written and spoken English
- Able to self-identify areas of their everyday lives in which they would like to improve.
Who cannot join
- Diagnosis of neurological conditions (e.g. dementia, mild cognitive impairment, Parkinson's)
- Presence of severe depression
- Presence of substance abuse
- History of hospitalization for psychiatric reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Cognitive and Functional Decline Among Seniors at Risk: A Community-Based Randomized Trial
This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of these approaches.
Read the detailed description
Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia. Many of these individuals report difficulties with complex activities of daily living.
RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive training approach that compensates for age-related executive changes. The approach is provided within the context of individually identified everyday-life difficulties.
The psycho-education approach is a Brain-Health Workshop supplemented by intellectually stimulating activities such as doing Sudoku and/or word searches. This approach provides information people may use to inform health behaviour changes.
- Conditions
- Subjective Cognitive Decline
- Being tested
- Real World Strategy Training, Psychosocial Education
- Keywords
- Age-related cognitive changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real World Strategy TrainingBehavioural
Also called Adopted Cognitive Orientation to Occupational Performance
The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
Psychosocial EducationBehavioural
The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sodoku puzzles. Homework will consist of reading assignments related to the session topics.
| Study group | Role | What they receive |
|---|---|---|
| Real World Strategy Training | Experimental | Group intervention including education and strategy training to manage everyday functional difficulties. Receives: Behavioral: Real World Strategy Training |
| Psychosocial Education | Active comparator | Group sessions including education on brain health. Receives: Behavioral: Psychosocial Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.
The COPM is a standardized semi-structure interview in which participants identify everyday life difficulties (defined as things they need to or want to do). These issues are converted to goals with performance rated on a 10-point Likert-type scale. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.
Measured: Changes from baseline to post-intervention at 10 weeks.
Secondary outcomes (5)
Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.
See primary outcome.
Measured: Three and six months post-intervention.
Improved satisfaction with performance on trained and untrained goals identified using the COPM.
Satisfaction with performance is measured on a 10-point Likert type scale using the COPM.
Measured: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.
Improved performance on the Multiple Errands Test (MET).
The MET is an ecologically valid, performance measure being used to determine if strategies learned in RWST are transferred to novel contexts. Best performance is achieved through completing all tasks (n=12) without breaking any rules (n=9).
Measured: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.nths post-intervention.
Change in health-related Quality of Life
Health-related quality of life will be measured using the SF-36.
Measured: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.
Improved performance on neuropsychological measures of executive function.
Changes in executive function are anticipated as meta-cognitive strategy training targets the executive control system. These will be measured using the Delis-Kaplan Executive Function System.
Measured: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start2 Nov 2017
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Deirdre Dawson, Baycrest
- Investigators
- Deirdre Dawson, PhD, Principal investigator, Rotman Research Institute, Baycrest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495037
- Sponsor's protocol ID
- REB1738
- Status last verified
- Jul 2021
- First submitted
- 22 Feb 2018
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rotenberg S, Anderson ND, Binns MA, Skidmore ER, Troyer AK, Richardson J, Xie F, Nalder E, Bar Y, Davids-Brumer N, Bernick A, Dawson DR. Effectiveness of a Meta-Cognitive Group Intervention for Older Adults with Subjective Cognitive Decline or Mild Cognitive Impairment: The ASPIRE Randomized Controlled Trial. J Prev Alzheimers Dis. 2024;11(6):1534-1548. doi: 10.14283/jpad.2024.166.
PubMed 39559867
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Cognitive and Functional Decline Among Seniors at Risk: A Community-Based Randomized Trial
- ClinicalTrials.gov ID
- NCT03495037
- Acronym / sponsor ID
- REB1738
- Conditions
- Subjective Cognitive Decline
- Keywords
- Age-related cognitive changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 11 Apr 2018 (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.
This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of these approaches.
Detailed description
Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia. Many of these individuals report difficulties with complex activities of daily living.
RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive training approach that compensates for age-related executive changes. The approach is provided within the context of individually identified everyday-life difficulties.
The psycho-education approach is a Brain-Health Workshop supplemented by intellectually stimulating activities such as doing Sudoku and/or word searches. This approach provides information people may use to inform health behaviour changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real World Strategy Training | Experimental | Behavioral: Real World Strategy TrainingGroup intervention including education and strategy training to manage everyday functional difficulties. |
| Psychosocial Education | Active comparator | Behavioral: Psychosocial EducationGroup sessions including education on brain health. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have subjective cognitive complaints
- Be fluent in written and spoken English
- Able to self-identify areas of their everyday lives in which they would like to improve.
Key exclusion criteria (4 listed)
- Diagnosis of neurological conditions (e.g. dementia, mild cognitive impairment, Parkinson's)
- Presence of severe depression
- Presence of substance abuse
- History of hospitalization for psychiatric reasons
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 |
|---|---|---|
| Real World Strategy TrainingAlso: Adopted Cognitive Orientation to Occupational PerformanceThe key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals. | Behavioural | Real World Strategy Training |
| Psychosocial EducationThe active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sodoku puzzles. Homework will consist of reading assignments related to the session topics. | Behavioural | Psychosocial Education |
Primary outcome
Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.
Time frame: Changes from baseline to post-intervention at 10 weeks.
The COPM is a standardized semi-structure interview in which participants identify everyday life difficulties (defined as things they need to or want to do). These issues are converted to goals with performance rated on a 10-point Likert-type scale. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.
5 secondary outcomes
Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.
Time frame: Three and six months post-intervention.
Improved satisfaction with performance on trained and untrained goals identified using the COPM.
Time frame: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.
Improved performance on the Multiple Errands Test (MET).
Time frame: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.nths post-intervention.
Change in health-related Quality of Life
Time frame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.
Improved performance on neuropsychological measures of executive function.
Time frame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.
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 21 Jul 2021.
- Derived from this study: PubMed 39559867Rotenberg S, Anderson ND, Binns MA, Skidmore ER, Troyer AK, Richardson J, Xie F, Nalder E, Bar Y, Davids-Brumer N, Bernick A, Dawson DR. Effectiveness of a Meta-Cognitive Group Intervention for Older Adults with Subjective Cognitive Decline or Mild Cognitive Impairment: The ASPIRE Randomized Controlled Trial. J Prev Alzheimers Dis. 2024;11(6):1534-1548. doi: 10.14283/jpad.2024.166.
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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.
Deirdre Dawson, PhD principal investigator
Rotman Research Institute, Baycrest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real World Strategy Training and Psychosocial Education in people with Subjective Cognitive Decline, run by Baycrest 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 3 inclusion and 4 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 21 Jul 2021. 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?
Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention. (time frame: Changes from baseline to post-intervention at 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495037, which also lists 1 linked publication.
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 21 Jul 2021.