Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
294 participants
INTERVENTIONAL
2018-01-01
2020-12-31
Brief Summary
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Detailed Description
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Each independent living community will administer one TBH program at a time such that participants will be randomly assigned to one of three categories: 1) one of the four educational programs, 2) an active "book club" that will read and discuss on tips to improve one's brain health, and 3) a wait-list control group. The older adults who agree to be a part of the research will be asked to fill out a survey at pre-intervention, post-intervention 1 (immediate), and post-intervention 2 (2 months). We predict that the participants in the TBH Brain Workout and TBH Memory programs (all difficulty levels) will have a greater knowledge about brain health, improved subjective appraisals of their memory, improved social outcomes, lower depression, and reduced dementia risk compared with the two control groups. We predict that the active book club control will differ on brain health knowledge than the wait-list control group. Due to the more cognitively challenging nature of the harder TBH programs, we also predicted that the harder versions would have greater improvement in brain health knowledge and improved subjective appraisals of their memory than the easier versions.
Power was calculated using the Bias- and Uncertainty-Corrected Sample Size (BUCCS) R package. This package was used because it allowed us to use effect sizes from a pilot study while considering bias and uncertainty in finding a similar effect size. Our pilot study used pre and post-test data from the Brain Health Fund of Knowledge Questionnaire (one of our primary outcome measures) in which we combined two active intervention groups that had earlier versions of the Total Brain Workout 1.0 and Memory 1.0 classes. The pilot data resulted in an F-value of 18.50 (effect size f = .56) from 67 total participants. Our alpha level was set to .0025 to consider a) new recommendations to set a generic alpha level to .005 and b) multiple comparisons corrections for our two primary outcome variables (i.e., Brain Health Fund of Knowledge Questionnaire and Potential for Improvement). The level of assurance and power was set to .8. Using two time points with these parameters, it was estimated that the investigators would need 49 participants per group to detect a significant effect.
Our plan is to recruit at least 49 participants from each of the six groups (four active and two control) through the through ACAR. Participation will be open for all independent living residents from January 2018 to January 2020. Participants will be aged 60 and older who have not been diagnosed with a memory disorder and are not currently engaging in other cognitive or brain training research. If the investigators are unable to reach our recruitment goals by January 2020, they will average together the 1.0 and 2.0 groups within each TBH program to achieve our desired sample size.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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TBH Brain Workout 1.0
The TBH Brain Workout program will cover education topics that encourage engagement in interventions shown to impact cognitive performance, including those to enhance intellectual (e.g., how to focus attention), physical (e.g., how to eat healthy), and socio-emotional (e.g., how to stay socially engaged) well-being. The challenge activities will be easy to master.
TBH Brain Workout 1.0
TBH Brain Workout program with easy challenge activities.
TBH Brain Workout 2.0
The TBH Brain Workout program will cover education topics that encourage engagement in interventions shown to impact cognitive performance, including those to enhance intellectual (e.g., how to focus attention), physical (e.g., how to eat healthy), and socio-emotional (e.g., how to stay socially engaged) well-being. The challenge activities will be moderately difficult to master.
TBH Brain Workout 2.0
TBH Brain Workout program with moderately difficult challenge activities.
TBH Memory 1.0
The TBH Memory program will cover educational topics on how memory works, what environmental factors impact memory, and memory strategies. The challenge activities will be easy to master.
TBH Memory 1.0
TBH Memory program with easy challenge activities.
TBH Memory 2.0
The TBH Memory program will cover educational topics on how memory works, what environmental factors impact memory, and memory strategies. The challenge activities will be moderately difficult to master.
TBH Memory 2.0
TBH Memory program with moderately difficult challenge activities
Book Club
The Book Club will be given a book to read on how to improve brain health and will discuss separate chapters across 8 sessions. These sessions will be led by the participants and no formal structure will be provided. No personal challenges will be asked of participants and no log will be required. All groups will have a sign-in sheet to record individual participation.
Brain Health Book Club
Each week a new chapter will be read that contains new information to enhance brain health.
No Contact Wait List
The Wait List group will simply take the the surveys at each time point as the other groups.
No interventions assigned to this group
Interventions
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TBH Brain Workout 1.0
TBH Brain Workout program with easy challenge activities.
Brain Health Book Club
Each week a new chapter will be read that contains new information to enhance brain health.
TBH Brain Workout 2.0
TBH Brain Workout program with moderately difficult challenge activities.
TBH Memory 1.0
TBH Memory program with easy challenge activities.
TBH Memory 2.0
TBH Memory program with moderately difficult challenge activities
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Currently engaging in other cognitive or brain training research
60 Years
ALL
Yes
Sponsors
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University of Alabama, Tuscaloosa
OTHER
Responsible Party
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Ian M. McDonough
Assistant Professor
Locations
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The University of Alabama
Tuscaloosa, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Ian M McDonough, PhD
Role: primary
References
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Cornwell EY, Waite LJ. Social disconnectedness, perceived isolation, and health among older adults. J Health Soc Behav. 2009 Mar;50(1):31-48. doi: 10.1177/002214650905000103.
Deckers K, van Boxtel MP, Schiepers OJ, de Vugt M, Munoz Sanchez JL, Anstey KJ, Brayne C, Dartigues JF, Engedal K, Kivipelto M, Ritchie K, Starr JM, Yaffe K, Irving K, Verhey FR, Kohler S. Target risk factors for dementia prevention: a systematic review and Delphi consensus study on the evidence from observational studies. Int J Geriatr Psychiatry. 2015 Mar;30(3):234-46. doi: 10.1002/gps.4245. Epub 2014 Dec 12.
Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
Lachman, M. E., Bandura, M., Weaver, S. L., & Elliott, E. (1995). Assessing memory control beliefs: The memory controllability inventory. Aging, Neuropsychology, and Cognition, 2(1), 67-84.
Orgeta V, Mukadam N, Sommerlad A, Livingston G. The Lancet Commission on Dementia Prevention, Intervention, and Care: a call for action. Ir J Psychol Med. 2019 Jun;36(2):85-88. doi: 10.1017/ipm.2018.4.
Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement, 1(3), 385-401.
Rosenberg A, Ngandu T, Rusanen M, Antikainen R, Backman L, Havulinna S, Hanninen T, Laatikainen T, Lehtisalo J, Levalahti E, Lindstrom J, Paajanen T, Peltonen M, Soininen H, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Solomon A, Kivipelto M. Multidomain lifestyle intervention benefits a large elderly population at risk for cognitive decline and dementia regardless of baseline characteristics: The FINGER trial. Alzheimers Dement. 2018 Mar;14(3):263-270. doi: 10.1016/j.jalz.2017.09.006. Epub 2017 Oct 19.
Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.
Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK542796/
Other Identifiers
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ACARTBH
Identifier Type: -
Identifier Source: org_study_id