AgingNCT02655497
Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints
A study testing Cognitive training and Psychosocial education in people with Aging, run by Baycrest at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effectiveness of cognitive strategies in improving participation in daily activities within older adults who report subjective cognitive decline. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Cognitive 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
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Sep 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling older adults aged 60+
- Fluent in written and spoken English
- Have subjective cognitive complaints (SCC)
- Performance within normal limits on a neuropsychological assessment battery
- Participants must also be able to self-identify specific areas of difficulty in their everyday life that they would like to improve
Who cannot join
- Significant neurological or psychiatric history (e.g., multiple sclerosis, psychiatric illness requiring hospitalization)
- Concurrent depression
- Anaesthesia in previous 6 months; and substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effectiveness of cognitive strategies in improving participation in daily activities within older adults who report subjective cognitive decline.
Read the detailed description
The planned project explores the effects of several interventions designed to promote independence in everyday life, with older adults who identify cognitive complaints. Evidence suggests that 25-50% of community dwelling older adults report cognitive difficulties, such as reduced memory or concentration, in the absence of any diagnosed condition. Cognitive skills are crucial to living independently. The investigators plan to examine two approaches in a randomized controlled trial. Based on our successful pilot study, the investigators hypothesize that this training which combines education on healthy lifestyles and problem solving training to address everyday life difficulties, will be effective in maximizing and maintaining independence of older adults.
- Conditions
- Aging
- Being tested
- Cognitive training, Psychosocial education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Psychosocial educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Cognitive training intervention. The intervention includes seven 2-hour group sessions interspersed with four individual 45-minute sessions for a total of 17 hours of intervention over an 8-week period. The experimental group will receive real-world strategy training, a cognitive strategy based approach that trains people to improve their level of independence on meaningful activities of daily life with which they are having difficulty. Receives: Behavioral: Cognitive training |
| Psychosocial education | Active comparator | The intervention includes seven 2-hour group sessions interspersed with four individual 45-minute sessions for a total of 17 hours of intervention over an 8-week period. The control group will receive brain-health education. Receives: Behavioral: Psychosocial education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Canadian Occupational Performance Measure (COPM) scores
The Canadian Occupational Performance Measure (COPM) is the primary outcome measure. All participants will identify five everyday life activities that they need to or want to do using the COPM. The primary outcome will be (a) the number of goals improved by two points.
Measured: 8 weeks after pretest and 3 months after intervention finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Deirdre Dawson, Baycrest
- Investigators
- Deirdre Dawson, PhD, Principal investigator, Baycrest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655497
- Sponsor's protocol ID
- REB#15-29
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2015
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints
- ClinicalTrials.gov ID
- NCT02655497
- Acronym / sponsor ID
- REB#15-29
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- 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 determine the effectiveness of cognitive strategies in improving participation in daily activities within older adults who report subjective cognitive decline.
Detailed description
The planned project explores the effects of several interventions designed to promote independence in everyday life, with older adults who identify cognitive complaints. Evidence suggests that 25-50% of community dwelling older adults report cognitive difficulties, such as reduced memory or concentration, in the absence of any diagnosed condition. Cognitive skills are crucial to living independently. The investigators plan to examine two approaches in a randomized controlled trial. Based on our successful pilot study, the investigators hypothesize that this training which combines education on healthy lifestyles and problem solving training to address everyday life difficulties, will be effective in maximizing and maintaining independence of older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive trainingCognitive training intervention. The intervention includes seven 2-hour group sessions interspersed with four individual 45-minute sessions for a total of 17 hours of intervention over an 8-week period. The experimental group will receive real-world strategy training, a cognitive strategy based approach that trains people to improve their level of independence on meaningful activities of daily life with which they are having difficulty. |
| Psychosocial education | Active comparator | Behavioral: Psychosocial educationThe intervention includes seven 2-hour group sessions interspersed with four individual 45-minute sessions for a total of 17 hours of intervention over an 8-week period. The control group will receive brain-health education. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community-dwelling older adults aged 60+
- Fluent in written and spoken English
- Have subjective cognitive complaints (SCC)
- Performance within normal limits on a neuropsychological assessment battery
- Participants must also be able to self-identify specific areas of difficulty in their everyday life that they would like to improve
Key exclusion criteria (3 listed)
- Significant neurological or psychiatric history (e.g., multiple sclerosis, psychiatric illness requiring hospitalization)
- Concurrent depression
- Anaesthesia in previous 6 months; and 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 |
|---|---|---|
| Cognitive training | Behavioural | Cognitive Training |
| Psychosocial education | Behavioural | Psychosocial education |
Primary outcome
Change in the Canadian Occupational Performance Measure (COPM) scores
Time frame: 8 weeks after pretest and 3 months after intervention finished
The Canadian Occupational Performance Measure (COPM) is the primary outcome measure. All participants will identify five everyday life activities that they need to or want to do using the COPM. The primary outcome will be (a) the number of goals improved by two points.
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 18 Nov 2016.
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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
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 Cognitive training 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 5 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 Nov 2016. 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?
Change in the Canadian Occupational Performance Measure (COPM) scores (time frame: 8 weeks after pretest and 3 months after intervention finished). 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 Nov 2016.