Executive Dysfunction Clinical Trial
— CCTOfficial title:
Does Computerized Cognitive Training Improve Executive Functioning in the Older Adult?
Verified date | November 2017 |
Source | University of the Sciences in Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Explanation of the study: As the older adult population continues to rise, so will normal
cognitive aging. This increase raises concern for maintaining cognitive function and possibly
delaying the onset of disorders such as dementia. Cognitive training (CT) is one potential
solution which may be done using computer programs, pencil-and-paper problem solving
activities, or everyday tasks. Traditional, skilled occupational therapy (OT) is not
reimbursed for this type of preventative or maintenance services. CT may be a fundable answer
for older adults to maintain or even improve cognitive function. The purpose is to determine
if computerized CT, utilizing a specific program (RehaCom), improves executive functioning in
the older adult with mild cognitive impairment, as compared to pencil-and-paper CT.
How study is performed: Participants who meet the inclusion criteria will complete a
9-question demographic survey and pre-test standardized cognitive tests. The experimental
group will complete RehaCom computer training and the control group will complete
paper-and-pencil based training. All trainings will take place at Mercy LIFE and will be
conducted by trained OT students. Subjects will complete a total of 480 minutes of training
over a 12-week period, within 30 to 60 minutes sessions. After the 480 minutes of training,
subjects will complete the cognitive post-tests.
How data is collected, de-identified and analyzed: Participants who enroll will be assigned a
code number linked to their first and last name. This coding will de-identify participants
before analyzing or reporting. All signed forms, data collected, and data identified will be
kept in a locked cabinet in the researcher's office. All stored files will be shredded one
year after the study.
Interventions/tests/medications:
Computerized CT: RehaCom is a computer program that was designed to assist cognitive
rehabilitation. The program targets attention, concentration, memory, perception, and
problem-solving, with trainings lasting for a total of 480 minutes over 12 weeks.
Pencil-and-paper CT: Various pencil-and-paper exercises to improve attention, concentration,
memory, language, and orientation will be used. Such exercises may include word puzzles,
calculation or number puzzles, and map reading, for a total of 480 minutes of training over
12 weeks.
Potential risks: Risks of feeling segregated are minimal, as all members have been offered
the opportunity to use the site's computer room. Risks may include cognitive fatigue (in both
groups) or overstimulation during computer use. Breaks will be given at any sign of these
symptoms. There is a small possibility that the participant may become too overwhelmed or
stressed with the cognitive training. Upon notice of these symptoms, activities will cease
immediately.
Potential and expected benefits: Participants may gain a greater insight into cognitive
abilities and improvement of executive functioning skills. Increased knowledge on effects of
using cognitive software in a community-based setting may also occur. Mercy LIFE will receive
the benefit of continued use of the RehaCom software and laptop as the equipment will be left
at the site. Additionally, these findings may help other community-based sites incorporate
specific cognitive training for other older adults.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | July 31, 2018 |
Est. primary completion date | November 3, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - Members of Mercy LIFE West Philadelphia - 55 years of age and older - Initial score of =20/30 on the Mini Mental State Examination (MMSE) - A current score of =17/30 on the Montreal Cognitive Assessment (MoCA) - Visual skills required to adequately view images on computer screens and paper, assessed by the subject's ability to read the information in the informed consent. Exclusion Criteria: - Younger than 55 years old - MMSE score < 21/30 - MoCA <18 - Inability to visually read information in the informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Mercy LIFE- West Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of the Sciences in Philadelphia | GenesisCAREs |
United States,
Alzheimer's Association. (2016, July 27). New reports from the Alzheimer's Association International Conference® 2016. Retrieved from: https://www.alz.org/aaic/releases_2016/wed_300_ET.asp
Baum, C. & Wolf, T. (2013). Executive Function Performance Test (EFPT). Retrieved from http://www.ot.wustl.edu/about/resources/executive-function-performance-test-efpt-308
Delis, D.C., Kaplan, E. & Kramer, J.H. (2001). The Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation.
Gaitán A, Garolera M, Cerulla N, Chico G, Rodriguez-Querol M, Canela-Soler J. Efficacy of an adjunctive computer-based cognitive training program in amnestic mild cognitive impairment and Alzheimer's disease: a single-blind, randomized clinical trial. Int J Geriatr Psychiatry. 2013 Jan;28(1):91-9. doi: 10.1002/gps.3794. Epub 2012 Apr 3. — View Citation
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Muller, K. D. (2016). A review of computer-based cognitive training for individuals with mild cognitive impairment and Alzheimer's Disease. Perspectives of the ASHA Special Interest Groups, 1(2), 47-61.
Mungas D. In-office mental status testing: a practical guide. Geriatrics. 1991 Jul;46(7):54-8, 63, 66. Review. — View Citation
Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. — View Citation
National Institute on Aging. (2014). Cognitive training shows staying power [Press Release]. Retrieved from https://www.nia.nih.gov/newsroom/2014/01/cognitive-training-shows-staying-power
Rebok GW, Ball K, Guey LT, Jones RN, Kim HY, King JW, Marsiske M, Morris JN, Tennstedt SL, Unverzagt FW, Willis SL; ACTIVE Study Group. Ten-year effects of the advanced cognitive training for independent and vital elderly cognitive training trial on cognition and everyday functioning in older adults. J Am Geriatr Soc. 2014 Jan;62(1):16-24. doi: 10.1111/jgs.12607. Epub 2014 Jan 13. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montreal Cognitive Assessment | Montreal Cognitive Assessment (MoCA): The MoCA was developed as a more challenging test that includes executive function, higher-level language, and complex visuospatial processing to enable detection of mild impairment with less ceiling effect than the MMSE. | 10 minutes | |
Primary | Delis-Kaplan Executive Functioning System (Letter Fluency) | Delis-Kaplan Executive Functioning System (D-KEFS) Verbal Fluency Test: Measures letter fluency. The evaluator instructs the subject, "I'm going to say a letter of the alphabet. When I say begin, I want you to tell me as many words as you can that begin with that letter. You will have 60 seconds before I tell you to stop. None of the words can be names of people, or places, or numbers." Score is obtained as the number of words recalled (duplicates or errors removed). | 5 minutes | |
Primary | Trail Making Test Part A | The Trail Making Test Part A: A test of visual conceptual and visuo-motor tracking. TMT-A measures attention, visual search and motor function; scored as time to completion. | 3 minutes | |
Primary | Trail Making Test Part B | The Trail Making Test Part B: A test of visual conceptual and visuo-motor tracking. TMT-B measures executive functioning, speed of attention, visual search and motor function; scored as time to completion. | 4 minutes | |
Secondary | Executive Function Performance Test | • Executive Function Performance Test (EFPT): The EFPT assesses the performance of four selected tasks that are essential for self-maintenance and independent living, such as oatmeal preparation, using the telephone, taking medication and paying bills. Each task has five items: initiation, organization, sequencing, judgment and safety, and completion, defined as executive functions. The total score is the sum of the performance on all four tasks, scored from 0 - 100. | 30 minutes |
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