AgingNCT02087137
Functional Impact of a Memory Intervention Program
A study testing Memory and Aging Program in people with Aging, run by Baycrest at 1 site in Canada.
Trial summary
Normal aging is associated with decline in some aspects of memory, and this can be a risk factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches positive adaptation to age-related memory changes, including strategies for minimizing the everyday impact of normal memory change and… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Memory and Aging Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Oct 2015
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-90
- Available to participate in all testing and intervention sessions (located in Toronto, Canada)
Who cannot join
- health conditions with major effects on cognition, including a current or previous history of stroke, brain surgery, or diagnosed neurological disorder
- dependence in instrumental activities of daily living
- cognitive impairment, defined as performance below cutoff for cognitive impairment on a standardized cognitive test, the Telephone Interview for Cognitive Status (Brandt, Spencer, \& Folstein, 1988).
- affective impairment, defined as performance below cutoff for depression on standardized depression screen, the Geriatric Depression Scale (Yesavage et al., 1983)
Trial locations and contacts
1 site in 1 country.
About this study
Normal aging is associated with decline in some aspects of memory, and this can be a risk factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches positive adaptation to age-related memory changes, including strategies for minimizing the everyday impact of normal memory change and positive lifestyle change to maximize brain health. Prior research has shown that the Memory and Aging program is effective in increasing participants' knowledge about memory, use of memory strategies, and confidence in memory function, as well as adoption of healthier lifestyle practices and reduction in intention to use unneeded health care resources.
Although not one of the stated goals of the program, informal feedback from participants suggests that the educational content and skills training in the Memory and Aging Program has led some participants to change behaviours in ways that lead to significant improvements in their everyday functioning. For example, graduating participants often volunteer examples of how they have applied what they have learned to succeed in everyday memory tasks such as learning a new name or keeping track of future plans. Based on this participant feedback, it is hypothesized that the knowledge, skills, and confidence gained by Memory and Aging Program participants may lead to positive behaviour changes that, in turn, lead to improved everyday functioning. The present study will test this hypothesis using a randomized controlled pretest-posttest design.
- Conditions
- Aging
- Being tested
- Memory and Aging Program
- Keywords
- aging, memory, memory training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory and Aging ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Memory and Aging Program | Active comparator | The Memory and Aging Program intervention consists of five 2-hour sessions conducted over five consecutive weeks. The content of the program includes: (a) the provision of factual information (i.e., about memory, age-related memory changes, lifestyle factors affecting memory, and memory strategies) in an informal lecture format; and (b) memory intervention (i.e., practice and application of several evidence-based memory strategies) in a hands-on interactive format. Receives: Behavioral: Memory and Aging Program |
| Wait-list Control | No intervention | Participants randomized to the wait-list control group will receive no intervention following randomization. They will be offered the intervention immediately following completion of the week 14 outcome testing session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in healthy lifestyle behaviours as measured by Health Promoting Lifestyle Profile II (Walker, Sechrist, & Pender, 1987)
Measured: Baseline, Week 8, week 14
Change from baseline in memory strategy use as measured by the Memory Strategy Toolbox (modified from Troyer, 2001)
Measured: Baseline, Week 8, week 14
Attainment of individualized goals for (a) lifestyle change, (b) memory strategy use, and (c) functional outcomes of memory strategy use as measured by Goal Attainment Scaling (Gordon, Powell, & Rockwood, 2000; Kiresuk, Smith, & Cardillo, 1994)
Measured: Baseline, Week 8, week 14
Secondary outcomes (5)
Change in positive and negative affect as measured by Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
Measured: Baseline, Week 8, week 14
Change in general health status as measured by the RAND 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992).
Measured: Baseline, Week 8, week 14
General Self-Efficacy Scale (Schwarzer & Jerusalem, 1995)
Measured: Baseline, Week 8, week 14
Prospective and Retrospective Memory Questionnaire (Smith, Della Sala, Logie, & Maylor, 2000)
Measured: Baseline, Week 8, week 14
Self-report health status, lifestyle changes, attitudes about aging
Measured: Baseline, Week 8, week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Vandermorris, Ph.D., C.Psych., Baycrest
- Investigators
- Susan Vandermorris, PhD, Principal investigator, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087137
- Sponsor's protocol ID
- 14-21
- Status last verified
- Jan 2016
- First submitted
- 12 Mar 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Brandt, J., Spencer, M., & Folstein, M. (1988). The Telephone Interview for Cognitive Status. Neuropsychiatry, Neuropsychology, & Behavioral Neurology, 1(2), 111-117.
Gordon J, Rockwood K, Powell C. Assessing patients' views of clinical changes. JAMA. 2000 Apr 12;283(14):1824-5. No abstract available.
PubMed 10770141Kiresuk, T. J., Smith, A., & Cardillo, J. E. (1994). Goal attainment scaling: Applications, theory, and measurement. Hillsdale, NJ: Lawrence Erlbaum Associates.
Troyer, A. K. (2001). Improving memory knowledge, satisfaction, and functioning via an education and intervention program for older adults. Aging, Neuropsychology, and Cognition, 8(4), 256-268.
Troyer AK, Hafliger A, Cadieux MJ, Craik FI. Name and face learning in older adults: effects of level of processing, self-generation, and intention to learn. J Gerontol B Psychol Sci Soc Sci. 2006 Mar;61(2):P67-74. doi: 10.1093/geronb/61.2.p67.
PubMed 16497956Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.
PubMed 11773220Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.
PubMed 3644262Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
PubMed 7183759Vandermorris S, Au A, Gardner S, Troyer AK. Initiation and maintenance of behaviour change to support memory and brain health in older adults: A randomized controlled trial. Neuropsychol Rehabil. 2022 May;32(4):611-628. doi: 10.1080/09602011.2020.1841656. Epub 2020 Nov 17.
PubMed 33203317Herdman KA, Vandermorris S, Davidson S, Au A, Troyer AK. Comparable achievement of client-identified, self-rated goals in intervention and no-intervention groups: reevaluating the use of Goal Attainment Scaling as an outcome measure. Neuropsychol Rehabil. 2019 Dec;29(10):1600-1610. doi: 10.1080/09602011.2018.1432490. Epub 2018 Feb 12.
PubMed 29430998
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Impact of a Memory Intervention Program
- ClinicalTrials.gov ID
- NCT02087137
- Acronym / sponsor ID
- 14-21
- Conditions
- Aging
- Keywords
- aging, memory, memory training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Mar 2014 (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.
Normal aging is associated with decline in some aspects of memory, and this can be a risk factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches positive adaptation to age-related memory changes, including strategies for minimizing the everyday impact of normal memory change and positive lifestyle change to maximize brain health. Prior research has shown that the Memory and Aging program is effective in increasing participants' knowledge about memory, use of memory strategies, and confidence in memory function, as well as adoption of healthier lifestyle practices and reduction in intention to use unneeded health care resources.
Although not one of the stated goals of the program, informal feedback from participants suggests that the educational content and skills training in the Memory and Aging Program has led some participants to change behaviours in ways that lead to significant improvements in their everyday functioning. For example, graduating participants often volunteer examples of how they have applied what they have learned to succeed in everyday memory tasks such as learning a new name or keeping track of future plans. Based on this participant feedback, it is hypothesized that the knowledge, skills, and confidence gained by Memory and Aging Program participants may lead to positive behaviour changes that, in turn, lead to improved everyday functioning. The present study will test this hypothesis using a randomized controlled pretest-posttest design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory and Aging Program | Active comparator | Behavioral: Memory and Aging ProgramThe Memory and Aging Program intervention consists of five 2-hour sessions conducted over five consecutive weeks. The content of the program includes: (a) the provision of factual information (i.e., about memory, age-related memory changes, lifestyle factors affecting memory, and memory strategies) in an informal lecture format; and (b) memory intervention (i.e., practice and application of several evidence-based memory strategies) in a hands-on interactive format. |
| Wait-list Control | No intervention | –Participants randomized to the wait-list control group will receive no intervention following randomization. They will be offered the intervention immediately following completion of the week 14 outcome testing session. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 50-90
- Available to participate in all testing and intervention sessions (located in Toronto, Canada)
Key exclusion criteria (4 listed)
- health conditions with major effects on cognition, including a current or previous history of stroke, brain surgery, or diagnosed neurological disorder
- dependence in instrumental activities of daily living
- cognitive impairment, defined as performance below cutoff for cognitive impairment on a standardized cognitive test, the Telephone Interview for Cognitive Status (Brandt, Spencer, \& Folstein, 1988).
- affective impairment, defined as performance below cutoff for depression on standardized depression screen, the Geriatric Depression Scale (Yesavage et al., 1983)
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 and Aging Program | Behavioural | Memory and Aging Program |
Primary outcome
Change from baseline in healthy lifestyle behaviours as measured by Health Promoting Lifestyle Profile II (Walker, Sechrist, & Pender, 1987)
Time frame: Baseline, Week 8, week 14
Change from baseline in memory strategy use as measured by the Memory Strategy Toolbox (modified from Troyer, 2001)
Time frame: Baseline, Week 8, week 14
Attainment of individualized goals for (a) lifestyle change, (b) memory strategy use, and (c) functional outcomes of memory strategy use as measured by Goal Attainment Scaling (Gordon, Powell, & Rockwood, 2000; Kiresuk, Smith, & Cardillo, 1994)
Time frame: Baseline, Week 8, week 14
5 secondary outcomes
Change in positive and negative affect as measured by Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
Time frame: Baseline, Week 8, week 14
Change in general health status as measured by the RAND 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992).
Time frame: Baseline, Week 8, week 14
General Self-Efficacy Scale (Schwarzer & Jerusalem, 1995)
Time frame: Baseline, Week 8, week 14
Prospective and Retrospective Memory Questionnaire (Smith, Della Sala, Logie, & Maylor, 2000)
Time frame: Baseline, Week 8, week 14
Self-report health status, lifestyle changes, attitudes about aging
Time frame: Baseline, Week 8, week 14
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 13 Jan 2016.
- BackgroundBrandt, J., Spencer, M., & Folstein, M. (1988). The Telephone Interview for Cognitive Status. Neuropsychiatry, Neuropsychology, & Behavioral Neurology, 1(2), 111-117.
- Background: PubMed 10770141Gordon J, Rockwood K, Powell C. Assessing patients' views of clinical changes. JAMA. 2000 Apr 12;283(14):1824-5. No abstract available.
- BackgroundKiresuk, T. J., Smith, A., & Cardillo, J. E. (1994). Goal attainment scaling: Applications, theory, and measurement. Hillsdale, NJ: Lawrence Erlbaum Associates.
- BackgroundTroyer, A. K. (2001). Improving memory knowledge, satisfaction, and functioning via an education and intervention program for older adults. Aging, Neuropsychology, and Cognition, 8(4), 256-268.
- Background: PubMed 16497956Troyer AK, Hafliger A, Cadieux MJ, Craik FI. Name and face learning in older adults: effects of level of processing, self-generation, and intention to learn. J Gerontol B Psychol Sci Soc Sci. 2006 Mar;61(2):P67-74. doi: 10.1093/geronb/61.2.p67.
- Background: PubMed 11773220Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.
- Background: PubMed 3644262Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 7183759Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
- Derived from this study: PubMed 33203317Vandermorris S, Au A, Gardner S, Troyer AK. Initiation and maintenance of behaviour change to support memory and brain health in older adults: A randomized controlled trial. Neuropsychol Rehabil. 2022 May;32(4):611-628. doi: 10.1080/09602011.2020.1841656. Epub 2020 Nov 17.
- Derived from this study: PubMed 29430998Herdman KA, Vandermorris S, Davidson S, Au A, Troyer AK. Comparable achievement of client-identified, self-rated goals in intervention and no-intervention groups: reevaluating the use of Goal Attainment Scaling as an outcome measure. Neuropsychol Rehabil. 2019 Dec;29(10):1600-1610. doi: 10.1080/09602011.2018.1432490. Epub 2018 Feb 12.
- Related InfoLink provided by the sponsor.
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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.
Susan Vandermorris, PhD principal investigator
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 Memory and Aging Program 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 2 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 13 Jan 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 from baseline in healthy lifestyle behaviours as measured by Health Promoting Lifestyle Profile II (Walker, Sechrist, & Pender, 1987) (time frame: Baseline, Week 8, week 14). 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?
On the ClinicalTrials.gov record for NCT02087137, which also lists 12 linked publications.
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 13 Jan 2016.