ACAR Brain Health Intervention Study

NCT04208880 | Unknown

• 1 other identifier: ACARTBH
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to assess the effectiveness of four Total Brain Health educational programs, TBH Brain Workout (1.0 and 2.0) and TBH Memory (1.0 and 2.0), in older adults residing in independent living facilities through the Acts Center for Applied Research (ACAR). Each TBH program trains for lifestyle intervention skills across the wellness spectrum shown by research to promote cognitive performance and reduce dementia risk, using social-based training methods, and experiential learning activities. Each TBH program also has two levels of difficulty (1.0 and 2.0), which will be assessed in independent groups. 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. All groups other than the wait-list control group will have 8 sessions across 2 months. 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. The investigators 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, the investigators 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.

Conditions

Aging Well

Keywords

Subjective Memory; Intervention; Brain Health; Educational Program; Well-being

Outcome Measures

Primary Outcomes (2)

• Brain Health Fund of Knowledge Questionnaire

  Test of knowledge of lifestyle factors that improve brain health, ranging from 0 to 30 with a higher score representing better knowledge.

  2 months

• Memory Controllability Inventory: Potential for Improvement (Lachman, 1995)

  Self-reported assessment of one's own potential to improve their own cognition with a minimum score of 3 and maximum of 21 with higher scores indicating greater potential for improvement.

  2 months

Secondary Outcomes (5)

• TBH Brain Workout Groups: Center for Epidemiological Survey-Depression (Radloff, 1977)

  2 months

• TBH Brain Workout Groups: Daily Habits Questionnaire

  2 months

• TBH Memory Groups: Multifactorial Memory Questionnaire (Troyer & Rich, 2002)

  2 months

• All Groups: Brain Health Fund of Knowledge Questionnaire

  4 months

• All Groups: Memory Controllability Inventory: Potential for Improvement (Lachman, 1995)

  4 months

Other Outcomes (3)

• All Groups: Modifiable Dementia Risk Questionnaire (based on Deckers et al., 2015)

  2 and 4 month time points

• All Groups: Revised UCLA Loneliness Scale (Hughes et al., 2004)

  2 and 4 month time points

• All Groups: The Social Disconnectedness Scale (Cornwell et al., 2009)

  2 and 4 month time points

Study Arms (6)

TBH Brain Workout 1.0

EXPERIMENTAL

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.

Behavioral: TBH Brain Workout 1.0

TBH Brain Workout 2.0

EXPERIMENTAL

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.

Behavioral: TBH Brain Workout 2.0

TBH Memory 1.0

EXPERIMENTAL

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.

Behavioral: TBH Memory 1.0

TBH Memory 2.0

EXPERIMENTAL

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.

Behavioral: TBH Memory 2.0

Book Club

ACTIVE COMPARATOR

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.

Behavioral: Brain Health Book Club

No Contact Wait List

NO INTERVENTION

The Wait List group will simply take the the surveys at each time point as the other groups.

Interventions

TBH Brain Workout 1.0 BEHAVIORAL

TBH Brain Workout program with easy challenge activities.

TBH Brain Workout 1.0

Brain Health Book Club BEHAVIORAL

Each week a new chapter will be read that contains new information to enhance brain health.

Book Club

TBH Brain Workout 2.0 BEHAVIORAL

TBH Brain Workout program with moderately difficult challenge activities.

TBH Brain Workout 2.0

TBH Memory 1.0 BEHAVIORAL

TBH Memory program with easy challenge activities.

TBH Memory 1.0

TBH Memory 2.0 BEHAVIORAL

TBH Memory program with moderately difficult challenge activities

TBH Memory 2.0

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60 and older

You may not qualify if:

• Diagnosed with a memory disorder
• Currently engaging in other cognitive or brain training research

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead

Study Sites (1)

The University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 19413133 BACKGROUND

• 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.

  PMID: 25504093 BACKGROUND

• 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.

  PMID: 18504506 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31187723 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29055814 BACKGROUND

• 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.

  PMID: 11773220 BACKGROUND

• Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK542796/

  PMID: 31219687 BACKGROUND

Central Study Contacts

Ian M McDonough, PhD

CONTACT

205-737-3442; immcdonough@ua.edu

Carpantato Myles, MSM, CIM, CIP

CONTACT

205-348-5746; cmyles@fa.ua.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants are assigned to one of six groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 23, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)