Clinical trial NCT02023944: Maintaining Cognitive Health in Aging Veterans
Official title: Maintaining Cognitive Health in Aging Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy People Programs
Keywords: Memory
Aging
Healthy People
Intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge of Memory Aging Questionnaire-Revised
timeFrame: Within 1 week of start of program
Secondary outcomes:
measure: Multifactorial Memory Questionnaire (MMQ)
timeFrame: Within 1 week of start of program
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
name: Maureen O'Connor, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.