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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02023944
Other study ID # E1389-P
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2013
Est. completion date November 1, 2017

Study information

Verified date February 2019
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Memory and Aging Course
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.

Locations

Country Name City State
United States Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Bedford Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. Review. — View 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. — View 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. Review. — View 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. — View 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: 1 — View Citation

Hisnanick JJ. Changes over time in the ADL status of elderly US veterans. Age Ageing. 1994 Nov;23(6):505-11. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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 f — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 1 week of start of program
Secondary 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 Within 1 week of start of program
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