Healthy People ProgramsNCT02023944
Maintaining Cognitive Health in Aging Veterans
A study testing Memory and Aging Course in people with Healthy People Programs, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Interventions aimed at disseminating information about cognitive aging and lifestyle factors that contribute to successful cognitive aging, in addition to providing broad cognitive skills training, may improve the psychological wellness and day-to-day functioning of the aging Veteran population. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy People Programs
- What is being tested?
- Memory and Aging Course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2013to 1 Nov 2017
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans age 50 and older who are concerned about their memory.
- Veterans age 50 and older who want to learn about memory processes.
Who cannot join
- Participants will be excluded if they display impairment on a cognitive screening measure, as determined using age and education corrected criteria with a minimum 90% specificity (using criteria: Schretlen, Testa, and Pearlson, 2010) as follows:
- Age Education MMSE Cut-off Specificity Sensitivity
- 51-55 / 26 or <
- 56-60 / 25 or <
- 61-65 / 25 or <
- 66-70 / 25 or <
Show all 10Show fewer
- 71-75 / 23 or <
- 76-80 / 23 or <
- 86+ / 22 or <
- Or self or informant reported diagnosis of a brain disorder affecting cognition such as Alzheimer's disease, Mild Cognitive Impairment, Parkinson's disease, other dementia, stroke, or brain injury or diagnosis of a major mental illness such as major depression, schizophrenia, or bipolar disorder; active alcohol or substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
Interventions aimed at disseminating information about cognitive aging and lifestyle factors that contribute to successful cognitive aging, in addition to providing broad cognitive skills training, may improve the psychological wellness and day-to-day functioning of the aging Veteran population. This 12-week course aims to teach older Veterans (age 50+) about brain aging, lifestyle factors that contribute to successful aging, and techniques that can boost cognition in daily life.
Read the detailed description
The proportion of Veterans over age 65 has risen from 11% to 26% from 1980 to 1990, and is estimated to rise to over 50% by 2030. Due to the growing number of older Veterans, health issues specific to the aging Veteran population is a primary concern for the Veterans Health Administration. Fear of developing dementia is common among older adults and minor memory lapses that were previously of little concern may be misinterpreted as signaling the beginning stages of dementia. Although normal cognitive aging is not the same as pathological aging, the impact of normal age-related changes warrants intervention since it can cause emotional distress and functional difficulties impacting occupational, recreational, and social pursuits and subjective cognitive impairment, defined as a noticed cognitive change without objective evidence of decline on neuropsychological testing may be the earliest precursor for dementia. While cognitive changes can be expected as we age, there is a growing body of literature demonstrating that modifiable lifestyle factors can influence functional ability and quality of life as one ages. In addition, cognitive training may result in improvements in cognition and functioning in older adults. Unfortunately, many older adults lack knowledge about cognitive aging and the factors that contribute to successful cognitive aging, which limits their ability to make changes that can improve the odds of successful cognitive aging. The need to disseminate information related to brain health has recently been recognized by key agencies involved in promoting the welfare of older adults, including the National Institutes of Neurological Disorders and Stroke, Mental Health, and Aging as well as the Centers for Disease Control and Prevention and the Alzheimer's Association. The current study builds upon previous work on cognitive intervention in older adults by investigating a multi-component intervention which includes psychoeducation about cognitive aging, presentation of lifestyle factors that contribute to successful cognitive aging, and broad cognitive skills training. Using a randomized controlled trial design, 72 Veterans will be assigned to either the intervention group (36) or a no treatment control group (36). Veterans will undergo baseline assessment, which will be used for comparison immediately following the intervention and at 3 and 6 month followup. Outcomes include knowledge of cognitive aging, measures of psychological wellness, and indicators of cognitive and functional ability.
- Conditions
- Healthy People Programs
- Being tested
- Memory and Aging Course
- Keywords
- Memory, Aging, Healthy People, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory and Aging CourseOther
This is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | 12-week course on memory and aging, consists of psychoeducation and skills training Receives: Other: Memory and Aging Course |
| Control, No Intervention | No intervention | No Intervention, considered "treatment as usual" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Memory Aging Questionnaire-Revised
Measures laypersons' knowledge of memory changes in adulthood for research or educational purposes using true/false/"don't know" questions, with half of the questions pertaining to normal memory aging and the other half covering pathological memory deficits due to non-normative factors, such as dementia. Test-retest reliability and convergent and discriminant validity were established at adequate levels. Minimum value is 0, maximum value is 28, higher scores indicate better knowledge of memory aging.
Measured: Within 1 week of start of program
Secondary outcomes (1)
Multifactorial Memory Questionnaire (MMQ)
The MMQ is a measure constructed to reflect aspects of memory that are potentially amenable to clinical intervention. The scale consists of three subscales - memory contentment, memory ability, and memory strategy use. Higher scores indicate, respectively, greater contentment, ability, and strategy use. Minimum 0, maximum 80
Measured: Within 1 week of start of program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study start1 Nov 2013
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
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.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Healthy People ProgramsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Maureen O'Connor, PsyD, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023944
- Sponsor's protocol ID
- E1389-P
- Status last verified
- Feb 2019
- First submitted
- 24 Dec 2013
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hisnanick JJ. Changes over time in the ADL status of elderly US veterans. Age Ageing. 1994 Nov;23(6):505-11. doi: 10.1093/ageing/23.6.505.
PubMed 9231946Commissaris CJ, Ponds RW, Jolles J. Subjective forgetfulness in a normal Dutch population: possibilities for health education and other interventions. Patient Educ Couns. 1998 May;34(1):25-32. doi: 10.1016/s0738-3991(98)00040-8.
PubMed 9697554Royall DR, Palmer R, Chiodo LK, Polk MJ. Declining executive control in normal aging predicts change in functional status: the Freedom House Study. J Am Geriatr Soc. 2004 Mar;52(3):346-52. doi: 10.1111/j.1532-5415.2004.52104.x.
PubMed 14962147Royall DR, Palmer R, Chiodo LK, Polk MJ. Executive control mediates memory's association with change in instrumental activities of daily living: the Freedom House Study. J Am Geriatr Soc. 2005 Jan;53(1):11-7. doi: 10.1111/j.1532-5415.2005.53004.x.
PubMed 15667370Dodge HH, Kita Y, Takechi H, Hayakawa T, Ganguli M, Ueshima H. Healthy cognitive aging and leisure activities among the oldest old in Japan: Takashima study. J Gerontol A Biol Sci Med Sci. 2008 Nov;63(11):1193-200. doi: 10.1093/gerona/63.11.1193.
PubMed 19038834Reisberg B, Shulman MB, Torossian C, Leng L, Zhu W. Outcome over seven years of healthy adults with and without subjective cognitive impairment. Alzheimers Dement. 2010 Jan;6(1):11-24. doi: 10.1016/j.jalz.2009.10.002.
PubMed 20129317Depp C, Vahia IV, Jeste D. Successful aging: focus on cognitive and emotional health. Annu Rev Clin Psychol. 2010;6:527-50. doi: 10.1146/annurev.clinpsy.121208.131449.
PubMed 20192798La Rue A. Healthy brain aging: role of cognitive reserve, cognitive stimulation, and cognitive exercises. Clin Geriatr Med. 2010 Feb;26(1):99-111. doi: 10.1016/j.cger.2009.11.003.
PubMed 20176296Unverzagt FW, Smith DM, Rebok GW, Marsiske M, Morris JN, Jones R, Willis SL, Ball K, King JW, Koepke KM, Stoddard A, Tennstedt SL. The Indiana Alzheimer Disease Center's Symposium on Mild Cognitive Impairment. Cognitive training in older adults: lessons from the ACTIVE Study. Curr Alzheimer Res. 2009 Aug;6(4):375-83. doi: 10.2174/156720509788929345.
PubMed 19689237Papp KV, Walsh SJ, Snyder PJ. Immediate and delayed effects of cognitive interventions in healthy elderly: a review of current literature and future directions. Alzheimers Dement. 2009 Jan;5(1):50-60. doi: 10.1016/j.jalz.2008.10.008.
PubMed 19118809Lustig C, Shah P, Seidler R, Reuter-Lorenz PA. Aging, training, and the brain: a review and future directions. Neuropsychol Rev. 2009 Dec;19(4):504-22. doi: 10.1007/s11065-009-9119-9. Epub 2009 Oct 30.
PubMed 19876740Anderson LA, Day KL, Beard RL, Reed PS, Wu B. The public's perceptions about cognitive health and Alzheimer's disease among the U.S. population: a national review. Gerontologist. 2009 Jun;49 Suppl 1:S3-11. doi: 10.1093/geront/gnp088.
PubMed 19525214Hendrie HC, Albert MS, Butters MA, Gao S, Knopman DS, Launer LJ, Yaffe K, Cuthbert BN, Edwards E, Wagster MV. The NIH Cognitive and Emotional Health Project. Report of the Critical Evaluation Study Committee. Alzheimers Dement. 2006 Jan;2(1):12-32. doi: 10.1016/j.jalz.2005.11.004.
PubMed 19595852O'Connor MK, Kraft ML, Daley R, Sugarman MA, Clark EL, Scoglio AAJ, Shirk SD. The Aging Well through Interaction and Scientific Education (AgeWISE) Program. Clin Gerontol. 2018 Oct-Dec;41(5):412-423. doi: 10.1080/07317115.2017.1387212. Epub 2017 Dec 8.
PubMed 29220623
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Cognitive Health in Aging Veterans
- ClinicalTrials.gov ID
- NCT02023944
- Acronym / sponsor ID
- E1389-P
- Conditions
- Healthy People Programs
- Keywords
- Memory, Aging, Healthy People, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventions aimed at disseminating information about cognitive aging and lifestyle factors that contribute to successful cognitive aging, in addition to providing broad cognitive skills training, may improve the psychological wellness and day-to-day functioning of the aging Veteran population. This 12-week course aims to teach older Veterans (age 50+) about brain aging, lifestyle factors that contribute to successful aging, and techniques that can boost cognition in daily life.
Detailed description
The proportion of Veterans over age 65 has risen from 11% to 26% from 1980 to 1990, and is estimated to rise to over 50% by 2030. Due to the growing number of older Veterans, health issues specific to the aging Veteran population is a primary concern for the Veterans Health Administration. Fear of developing dementia is common among older adults and minor memory lapses that were previously of little concern may be misinterpreted as signaling the beginning stages of dementia. Although normal cognitive aging is not the same as pathological aging, the impact of normal age-related changes warrants intervention since it can cause emotional distress and functional difficulties impacting occupational, recreational, and social pursuits and subjective cognitive impairment, defined as a noticed cognitive change without objective evidence of decline on neuropsychological testing may be the earliest precursor for dementia. While cognitive changes can be expected as we age, there is a growing body of literature demonstrating that modifiable lifestyle factors can influence functional ability and quality of life as one ages. In addition, cognitive training may result in improvements in cognition and functioning in older adults. Unfortunately, many older adults lack knowledge about cognitive aging and the factors that contribute to successful cognitive aging, which limits their ability to make changes that can improve the odds of successful cognitive aging. The need to disseminate information related to brain health has recently been recognized by key agencies involved in promoting the welfare of older adults, including the National Institutes of Neurological Disorders and Stroke, Mental Health, and Aging as well as the Centers for Disease Control and Prevention and the Alzheimer's Association. The current study builds upon previous work on cognitive intervention in older adults by investigating a multi-component intervention which includes psychoeducation about cognitive aging, presentation of lifestyle factors that contribute to successful cognitive aging, and broad cognitive skills training. Using a randomized controlled trial design, 72 Veterans will be assigned to either the intervention group (36) or a no treatment control group (36). Veterans will undergo baseline assessment, which will be used for comparison immediately following the intervention and at 3 and 6 month followup. Outcomes include knowledge of cognitive aging, measures of psychological wellness, and indicators of cognitive and functional ability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Memory and Aging Course12-week course on memory and aging, consists of psychoeducation and skills training |
| Control, No Intervention | No intervention | –No Intervention, considered "treatment as usual" |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans age 50 and older who are concerned about their memory.
- Veterans age 50 and older who want to learn about memory processes.
Key exclusion criteria (10 listed)
- Participants will be excluded if they display impairment on a cognitive screening measure, as determined using age and education corrected criteria with a minimum 90% specificity (using criteria: Schretlen, Testa, and Pearlson, 2010) as follows:
- Age Education MMSE Cut-off Specificity Sensitivity
- 51-55 / 26 or <
- 56-60 / 25 or <
- 61-65 / 25 or <
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 CourseThis is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older. | Other | Intervention |
Primary outcome
Knowledge of Memory Aging Questionnaire-Revised
Time frame: Within 1 week of start of program
Measures laypersons' knowledge of memory changes in adulthood for research or educational purposes using true/false/"don't know" questions, with half of the questions pertaining to normal memory aging and the other half covering pathological memory deficits due to non-normative factors, such as dementia. Test-retest reliability and convergent and discriminant validity were established at adequate levels. Minimum value is 0, maximum value is 28, higher scores indicate better knowledge of memory aging.
1 secondary outcome
Multifactorial Memory Questionnaire (MMQ)
Time frame: Within 1 week of start of program
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 9231946Hisnanick JJ. Changes over time in the ADL status of elderly US veterans. Age Ageing. 1994 Nov;23(6):505-11. doi: 10.1093/ageing/23.6.505.
- Results publication: PubMed 9697554Commissaris CJ, Ponds RW, Jolles J. Subjective forgetfulness in a normal Dutch population: possibilities for health education and other interventions. Patient Educ Couns. 1998 May;34(1):25-32. doi: 10.1016/s0738-3991(98)00040-8.
- Results publication: PubMed 14962147Royall DR, Palmer R, Chiodo LK, Polk MJ. Declining executive control in normal aging predicts change in functional status: the Freedom House Study. J Am Geriatr Soc. 2004 Mar;52(3):346-52. doi: 10.1111/j.1532-5415.2004.52104.x.
- Results publication: PubMed 15667370Royall DR, Palmer R, Chiodo LK, Polk MJ. Executive control mediates memory's association with change in instrumental activities of daily living: the Freedom House Study. J Am Geriatr Soc. 2005 Jan;53(1):11-7. doi: 10.1111/j.1532-5415.2005.53004.x.
- Results publication: PubMed 19038834Dodge HH, Kita Y, Takechi H, Hayakawa T, Ganguli M, Ueshima H. Healthy cognitive aging and leisure activities among the oldest old in Japan: Takashima study. J Gerontol A Biol Sci Med Sci. 2008 Nov;63(11):1193-200. doi: 10.1093/gerona/63.11.1193.
- Results publication: PubMed 20129317Reisberg B, Shulman MB, Torossian C, Leng L, Zhu W. Outcome over seven years of healthy adults with and without subjective cognitive impairment. Alzheimers Dement. 2010 Jan;6(1):11-24. doi: 10.1016/j.jalz.2009.10.002.
- Results publication: PubMed 20192798Depp C, Vahia IV, Jeste D. Successful aging: focus on cognitive and emotional health. Annu Rev Clin Psychol. 2010;6:527-50. doi: 10.1146/annurev.clinpsy.121208.131449.
- Results publication: PubMed 20176296La Rue A. Healthy brain aging: role of cognitive reserve, cognitive stimulation, and cognitive exercises. Clin Geriatr Med. 2010 Feb;26(1):99-111. doi: 10.1016/j.cger.2009.11.003.
- Results publication: PubMed 19689237Unverzagt FW, Smith DM, Rebok GW, Marsiske M, Morris JN, Jones R, Willis SL, Ball K, King JW, Koepke KM, Stoddard A, Tennstedt SL. The Indiana Alzheimer Disease Center's Symposium on Mild Cognitive Impairment. Cognitive training in older adults: lessons from the ACTIVE Study. Curr Alzheimer Res. 2009 Aug;6(4):375-83. doi: 10.2174/156720509788929345.
- Results publication: PubMed 19118809Papp KV, Walsh SJ, Snyder PJ. Immediate and delayed effects of cognitive interventions in healthy elderly: a review of current literature and future directions. Alzheimers Dement. 2009 Jan;5(1):50-60. doi: 10.1016/j.jalz.2008.10.008.
- Results publication: PubMed 19876740Lustig C, Shah P, Seidler R, Reuter-Lorenz PA. Aging, training, and the brain: a review and future directions. Neuropsychol Rev. 2009 Dec;19(4):504-22. doi: 10.1007/s11065-009-9119-9. Epub 2009 Oct 30.
- Results publication: PubMed 19525214Anderson LA, Day KL, Beard RL, Reed PS, Wu B. The public's perceptions about cognitive health and Alzheimer's disease among the U.S. population: a national review. Gerontologist. 2009 Jun;49 Suppl 1:S3-11. doi: 10.1093/geront/gnp088.
- Individual participant dataSharing planned: No
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.
Maureen O'Connor, PsyD principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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 Course in people with Healthy People Programs, run by VA Office of Research and Development at 1 site in United States.
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 10 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 31 May 2019. 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 United States. 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 31 May 2019). 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?
Knowledge of Memory Aging Questionnaire-Revised (time frame: Within 1 week of start of program). 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 NCT02023944, which also lists 14 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 31 May 2019; AzTrials last refreshed its copy on 1 Nov 2026.