Does Computerized Cognitive Training Improve Executive Functioning in the Older Adult?

NCT03170492 | Unknown DMC

• 1 other identifier: 947324
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment, Mild; Executive Dysfunction

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Executive Function Performance Test

  30 minutes

Study Arms (2)

Computerized Cognitive Training

EXPERIMENTAL

RehaCom for 480 minutes over 12 weeks.

Other: RehaCom Computerized Cognitive Training for 480 minutes

Pencil-and-Paper Cognitive Training

ACTIVE COMPARATOR

Table-top based activities for 480 minutes over 12 weeks.

Other: Pencil-and-Paper Cognitive Training for 480 minutes

Interventions

RehaCom Computerized Cognitive Training for 480 minutes OTHER

Student OT doctoral researchers will guide the subject when participating in the RehaCom program. RehaCom is computer hardware and software designed for assisted cognitive rehabilitation. The program is designed to target specific aspects of attention, concentration, memory, perception, and problem-solving. As the training goes on, the tasks will become easier or harder depending on the subject's performance. The first session will begin with a screening module with an example and a practice session to make sure the client understands the task. After screening, the results page shows the subject's performance compared with age-matched norms. This gives a helpful indication as to the severity of the deficit and advises the researcher on the particular training module to be used. The subject will continue the training modules for a total of 480 minutes of training over 12 weeks.

Computerized Cognitive Training

Pencil-and-Paper Cognitive Training for 480 minutes OTHER

Student OT doctoral researchers will engage the subject in various pen-and-paper exercises designed to improve cognitive functions: attention and concentration, memory, language, calculation, and orientation. These could include, but are not limited to: word puzzles, calculation or number puzzles, and map reading. The subject will continue the training modules for a total of 480 minutes of training over 12 weeks.

Pencil-and-Paper Cognitive Training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Members of Mercy LIFE West Philadelphia
• 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.

You may not qualify if:

• Younger than 55 years old
• MMSE score \< 21/30
• MoCA \<18
• Inability to visually read information in the informed consent.

Sponsors & Collaborators

• University of the Sciences in Philadelphia: lead
• GenesisCAREs: collaborator

Study Sites (1)

Mercy LIFE- West Philadelphia

Philadelphia, Pennsylvania, 18049, United States

Location

Related Publications (14)

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  BACKGROUND

• 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

  BACKGROUND

• Delis, D.C., Kaplan, E. & Kramer, J.H. (2001). The Delis-Kaplan Executive Function System. San Antonio, TX: The Psychological Corporation.

  BACKGROUND

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  PMID: 17362383 BACKGROUND

• Gaitan 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.

  PMID: 22473855 BACKGROUND

• Jaeggi SM, Buschkuehl M, Jonides J, Shah P. Short- and long-term benefits of cognitive training. Proc Natl Acad Sci U S A. 2011 Jun 21;108(25):10081-6. doi: 10.1073/pnas.1103228108. Epub 2011 Jun 13.

  PMID: 21670271 BACKGROUND

• 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.

  BACKGROUND

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  PMID: 2060803 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian 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. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24417410 BACKGROUND

• Singh-Manoux A, Richards M, Marmot M. Leisure activities and cognitive function in middle age: evidence from the Whitehall II study. J Epidemiol Community Health. 2003 Nov;57(11):907-13. doi: 10.1136/jech.57.11.907.

  PMID: 14600119 BACKGROUND

• Strauss, E., Sherman, E.M.S. & Spreen, O. (2006) Trail making test. In: A Compendium of Neuropsychological Tests. New York: Oxford University Press, 655-659.

  BACKGROUND

• Trzepacz PT, Hochstetler H, Wang S, Walker B, Saykin AJ; Alzheimer's Disease Neuroimaging Initiative. Relationship between the Montreal Cognitive Assessment and Mini-mental State Examination for assessment of mild cognitive impairment in older adults. BMC Geriatr. 2015 Sep 7;15:107. doi: 10.1186/s12877-015-0103-3.

  PMID: 26346644 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sara Benham, OTD

  University of the Sciences in Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 31, 2017
• Study Start: January 30, 2017
• Primary Completion: November 3, 2017
• Study Completion: July 31, 2018
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)