AgingNCT01163279
Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction.
A study testing Real world strategy approach and Psychosocial Education in people with Aging, run by Baycrest at 1 site in Canada.
Trial summary
Healthy older adults with self-reported cognitive difficulties who receive strategy training will demonstrate greater performance benefits on measures of real-world activities, relative to those receiving a control intervention, immediately post treatment and at follow-up. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Real world strategy approach and Psychosocial Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All participants must score within 1.5 standard deviation (SD) of age and education-corrected normative data for the Montreal Cognitive Assessment and on a battery of neuropsychological tests of attention, memory and executive function (which will insure that participants are unlikely to meet the criteria for Mild Cognitive Impairment (MCI)).
- No clinically relevant depression (scores ≤22) on the Center for Epidemiologic Studies Depression Scale (CES-D)
- Fluent in written and spoken English
- Self-reported complains about cognitive function
Who cannot join
- Recent bereavement (within last 6 months)
- History of neurological disease
- Psychiatric illness requiring hospitalization and/or history or current substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintaining Autonomy as we Age: Investigating the Application of a Strategy Training Approach for Ameliorating the Effects of Age-related Executive Dysfunction - Part II
Healthy older adults with self-reported cognitive difficulties who receive strategy training will demonstrate greater performance benefits on measures of real-world activities, relative to those receiving a control intervention, immediately post treatment and at follow-up.
- Conditions
- Aging
- Being tested
- Real world strategy approach, Psychosocial Education
- Keywords
- Age-related changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real world strategy approachBehavioural
Also called Adopted Cognitive Orientation to Occupational Performance (CO-OP)
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 Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Not described Receives: Behavioral: Real world strategy approach |
| Psychosocial Education | Active comparator | Not described Receives: Behavioral: Psychosocial Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)
COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.
Measured: Immediately post intervention (2 months) and 3 months later
Secondary outcomes (10)
General Self Efficacy Scale (GSE)
GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- General Health Subscale
Stanford Patient Education Research Center has different measures of health related behaviors. General Health is one of the subscales. scores range 1-5 and higher score indicate better general health
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- Health Distress Subscale
Stanford Patient Education Research Center has different measures of health related behaviors. Health distress is one of the subscales. Scores range 0-20 and higher score indicates more distress.
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- Physical Activity Subscale
Stanford Patient Education Research Center has different measures of health related behaviors. Physical activity is one of the subscales. Scores indicate number of hours of physical activity per week
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- Communication With Physicians Subscale
Stanford Patient Education Research Center has different measures of health related behaviors. communication with physicians is one of the subscales. Scores range 1-15 and higher score indicates more preparation for visits and greater ability to ask questions
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale
Stanford Patient Education Research Center has different measures of health related behaviors. Visits to physician and emergency department in the past six months subscale is one of the subscales.
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time
This is a measure of executive function. The score reflects the average of the participant's first-move times, i.e. the time a participant took to make the first move
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
DKEFS Tower Test- Achievement Score
This is a measure of executive function. Total achievement scores indicate the highest score participants scored on the test. The lowest score possible is 0 and the highest score possible is 30. Higher scores indicate better performance.
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
DKEFS Word Fluency
This is a measure of executive function where participants are given a letter and asked to generate as many words as they can think of within 60 seconds
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
DKEFS Trail Making- Condition 4: Number-letter Switching
DKEFS trail making condition 4 is a measure of executive function that requires the participant to switch back and forth between connecting numbers and letters in a sequence
Measured: Baseline, Immediately post intervention (2 months) and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163279
- Sponsor's protocol ID
- REB1021
- Status last verified
- Nov 2017
- First submitted
- 14 Jul 2010
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Autonomy as we Age: Investigating the Application of a Strategy Training Approach for Ameliorating the Effects of Age-related Executive Dysfunction - Part II
- ClinicalTrials.gov ID
- NCT01163279
- Acronym / sponsor ID
- REB1021
- Conditions
- Aging
- Keywords
- Age-related changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Posted 12 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy older adults with self-reported cognitive difficulties who receive strategy training will demonstrate greater performance benefits on measures of real-world activities, relative to those receiving a control intervention, immediately post treatment and at follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Real world strategy approach |
| Psychosocial Education | Active comparator | Behavioral: Psychosocial Education |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- All participants must score within 1.5 standard deviation (SD) of age and education-corrected normative data for the Montreal Cognitive Assessment and on a battery of neuropsychological tests of attention, memory and executive function (which will insure that participants are unlikely to meet the criteria for Mild Cognitive Impairment (MCI)).
- No clinically relevant depression (scores ≤22) on the Center for Epidemiologic Studies Depression Scale (CES-D)
- Fluent in written and spoken English
- Self-reported complains about cognitive function
Key exclusion criteria (3 listed)
- Recent bereavement (within last 6 months)
- History of neurological disease
- Psychiatric illness requiring hospitalization and/or history or current substance abuse
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 approachAlso: Adopted Cognitive Orientation to Occupational Performance (CO-OP)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. | Behavioural | Cognitive 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 Sudoku puzzles. Homework will consist of reading assignments related to the session topics. | Behavioural | Psychosocial Education |
Primary outcome
Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)
Time frame: Immediately post intervention (2 months) and 3 months later
COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.
10 secondary outcomes
General Self Efficacy Scale (GSE)
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- General Health Subscale
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- Health Distress Subscale
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- Physical Activity Subscale
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- Communication With Physicians Subscale
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
DKEFS Tower Test- Achievement Score
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
DKEFS Word Fluency
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
DKEFS Trail Making- Condition 4: Number-letter Switching
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
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 approach and Psychosocial Education in people with Aging, 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 4 inclusion and 3 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 18 Dec 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?
Yes. Results are posted in the registry (first posted 12 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) (time frame: Immediately post intervention (2 months) and 3 months later). 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 18 Dec 2017.