- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023944
Maintaining Cognitive Health in Aging Veterans
February 27, 2019 updated by: VA Office of Research and Development
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Bedford, Massachusetts, United States, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Veterans age 50 and older who are concerned about their memory.
- Veterans age 50 and older who want to learn about memory processes.
Exclusion Criteria:
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 <
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
12-week course on memory and aging, consists of psychoeducation and skills training
|
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.
|
No Intervention: Control, No Intervention
No Intervention, considered "treatment as usual"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within 1 week of start of program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multifactorial Memory Questionnaire (MMQ)
Time Frame: Within 1 week of start of program
|
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
|
Within 1 week of start of program
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maureen O'Connor, PsyD, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Commissaris 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.
- Royall 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.
- Royall 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.
- Dodge 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.
- Reisberg 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.
- Depp 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.
- La 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.
- Unverzagt 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.
- Papp 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.
- Lustig 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.
- Anderson 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.
- Hendrie 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.
- O'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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2013
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
November 1, 2017
Study Registration Dates
First Submitted
December 24, 2013
First Submitted That Met QC Criteria
December 24, 2013
First Posted (Estimate)
December 30, 2013
Study Record Updates
Last Update Posted (Actual)
May 31, 2019
Last Update Submitted That Met QC Criteria
February 27, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E1389-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy People Programs
-
Universidad Católica del MauleCompleted
-
Universidade do PortoFundação para a Ciência e a TecnologiaRecruitingBoxing Training, Physical-functional Fitness and Cognitive Performance in Older Adults (Boxe4Ageing)Healthy People ProgramsPortugal
-
Fundació Institut de Recerca de l'Hospital de la...CompletedHealthy People ProgramsSpain
-
Universidade Federal do vale do São FranciscoConselho Nacional de Desenvolvimento Científico e TecnológicoRecruiting
-
HES-SO Valais-WallisEnrolling by invitationHealthy PeopleSwitzerland
-
Qilu Pharmaceutical Co., Ltd.Unknown
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Acibadem UniversityMarmara UniversityCompletedHealthy Young PeopleTurkey
-
Marmara UniversityCompleted
Clinical Trials on Memory and Aging Course
-
BaycrestCentre for Aging and Brain Health InnovationCompletedAging | Cognitive DeclineCanada
-
University College, LondonCompletedAlzheimer Disease | Frontotemporal Dementia | Primary Progressive AphasiaUnited Kingdom
-
Trans Tasman Radiation Oncology GroupAustralasian Gastro-Intestinal Trials Group; Colorectal Surgical Society of... and other collaboratorsCompletedAdenocarcinoma of RectumAustralia, New Zealand
-
VA Office of Research and DevelopmentUniversity of MarylandCompleted
-
University of ChicagoNational Institute of Mental Health (NIMH)RecruitingBasic Research to Understand Hippocampal Memory FunctionUnited States
-
University of Milano BicoccaFondazione Golgi CenciCompletedLoneliness | Social IsolationItaly
-
Brown UniversityNational Institute on Aging (NIA); WestatCompleted
-
Integrative Skin Science and ResearchAgeLess Sciences Inc.Active, not recruiting
-
Hôpital le VinatierCompleted