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Aging WellNCT04208880

ACAR Brain Health Intervention Study

A study testing TBH Brain Workout 1.0, Brain Health Book Club and TBH Brain Workout 2.0 in people with Aging Well, run by University of Alabama, Tuscaloosa at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging Well
What is being tested?
TBH Brain Workout 1.0, Brain Health Book Club and TBH Brain Workout 2.0
Could I receive a placebo?
No, everyone receives an active treatment
How many people
294 participants
Where
1 siteUnited States
Study dates
1 Jan 2018to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 60 and older

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ian M McDonough, PhD contact

205-737-3442

immcdonough@ua.edu

Carpantato Myles, MSM, CIM, CIP contact

205-348-5746

cmyles@fa.ua.edu

United States1 site, 1 recruiting
  • The University of Alabama

    Tuscaloosa, Alabama, 35487

    Ian M McDonough, PhD, 205-737-3442, immcdonough@ua.edu

    Recruiting

Other trials in United States

About this study

Official title: ACAR Brain Health Intervention Study: A Preliminary Investigation of Subjective Memory and Well-Being

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.

Read the detailed description

Current evidence suggests that behavioral lifestyle modifications may improve everyday cognitive performance, thereby reducing dementia risk. 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 cognitively independent adults residing in independent living facilities through the Acts Center for Applied Research (ACAR). Each TBH program trains skills across the wellness spectrum demonstrated to impact cognitive risk, use social-based training methods, and has experiential learning activities. Each of the two TBH educational programs has two levels of difficulty. The TBH Brain Workout program will consist of 8 sessions that covers topics to 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 TBH Memory program will consist of 8 sessions that covers education on how memory works, what environmental factors impact memory, and memory strategies. Participants in both TBH programs will be guided through activities with a trainer, but also will have active learning activities that will include teaching others (collaborative learning), competitive teams, and whole class activities. The more challenging versions of each program (level 2.0) will also include "challenge" activities that encourage them to engage daily in an activity that requires movement, an activity that requires giving thanks, or an activity than requires mental stimulation. Participants will log which challenge activities they engaged in each week. 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.

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
Aging Well
Being tested
TBH Brain Workout 1.0, Brain Health Book Club, TBH Brain Workout 2.0, TBH Memory 1.0, TBH Memory 2.0
Keywords
Subjective Memory, Intervention, Brain Health, Educational Program, Well-being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TBH Brain Workout 1.0Behavioural

    TBH Brain Workout program with easy challenge activities.

  • Brain Health Book ClubBehavioural

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

  • TBH Brain Workout 2.0Behavioural

    TBH Brain Workout program with moderately difficult challenge activities.

  • TBH Memory 1.0Behavioural

    TBH Memory program with easy challenge activities.

  • TBH Memory 2.0Behavioural

    TBH Memory program with moderately difficult challenge activities

Study groups in NCT04208880
Study groupRoleWhat they receive
TBH Brain Workout 1.0ExperimentalThe 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.
Receives: Behavioral: TBH Brain Workout 1.0
TBH Brain Workout 2.0ExperimentalThe 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.
Receives: Behavioral: TBH Brain Workout 2.0
TBH Memory 1.0ExperimentalThe 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.
Receives: Behavioral: TBH Memory 1.0
TBH Memory 2.0ExperimentalThe 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.
Receives: Behavioral: TBH Memory 2.0
Book ClubActive comparatorThe 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.
Receives: Behavioral: Brain Health Book Club
No Contact Wait ListNo interventionThe Wait List group will simply take the the surveys at each time point as the other groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 months

  2. 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.

    Measured: 2 months

Secondary outcomes (5)
  1. TBH Brain Workout Groups: Center for Epidemiological Survey-Depression (Radloff, 1977)

    Self-reported assessment of depressive symptoms, ranging from 0 to 60 where higher scores indicate more depression.

    Measured: 2 months

  2. TBH Brain Workout Groups: Daily Habits Questionnaire

    Self-reported assessment of engagement in daily activities that promote brain health, ranging from 30 to 210 where higher scores represent more engagement in daily health habits.

    Measured: 2 months

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

    Self-reported assessment of subjective memory on contentment (ranging from 9-72), ability (ranging from 0-77), and strategy (ranging from 9-64) with higher scores being better.

    Measured: 2 months

  4. All Groups: 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.

    Measured: 4 months

  5. All Groups: 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study start1 Jan 2018
  3. Primary completionJan 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to one of six groups in parallel for the duration of the study.
Masking
None (open label)
Enrolment
294 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04208880
Sponsor's protocol ID
ACARTBH
Status last verified
Dec 2019
First submitted
18 Dec 2019
Last updated
23 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19413133
  • 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.

    PubMed 25504093
  • 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.

    PubMed 18504506
  • 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.

    PubMed 31187723
  • 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.

    PubMed 29055814
  • 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.

    PubMed 11773220
  • Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK542796/

    PubMed 31219687

Questions about this trial

What is this clinical trial studying?

A study testing TBH Brain Workout 1.0, Brain Health Book Club and TBH Brain Workout 2.0 in people with Aging Well, run by University of Alabama, Tuscaloosa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ian M McDonough, PhD (205-737-3442, immcdonough@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Health Fund of Knowledge Questionnaire (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04208880, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.

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