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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama
Tuscaloosa, Alabama, 35487
Ian M McDonough, PhD, 205-737-3442, immcdonough@ua.edu
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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.
- First posted23 Dec 2019
- Study start1 Jan 2018
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian M. McDonough, University of Alabama, Tuscaloosa
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 19413133Deckers 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 25504093Hughes 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 18504506Lachman, 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 31187723Radloff, 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 29055814Troyer 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 11773220Risk 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACAR Brain Health Intervention Study: A Preliminary Investigation of Subjective Memory and Well-Being
- ClinicalTrials.gov ID
- NCT04208880
- Acronym / sponsor ID
- ACARTBH
- Conditions
- Aging Well
- Keywords
- Subjective Memory, Intervention, Brain Health, Educational Program, Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Participants are assigned to one of six groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| TBH Brain Workout 1.0 | Experimental | Behavioral: TBH Brain Workout 1.0The 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 2.0 | Experimental | Behavioral: TBH Brain Workout 2.0The 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 Memory 1.0 | Experimental | Behavioral: TBH Memory 1.0The 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 2.0 | Experimental | Behavioral: TBH Memory 2.0The 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. |
| Book Club | Active comparator | Behavioral: Brain Health Book ClubThe 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. |
| No Contact Wait List | No intervention | –The Wait List group will simply take the the surveys at each time point as the other groups. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 60 and older
Key exclusion criteria (2 listed)
- Diagnosed with a memory disorder
- Currently engaging in other cognitive or brain training research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBH Brain Workout 1.0TBH Brain Workout program with easy challenge activities. | Behavioural | TBH Brain Workout 1.0 |
| Brain Health Book ClubEach week a new chapter will be read that contains new information to enhance brain health. | Behavioural | Book Club |
| TBH Brain Workout 2.0TBH Brain Workout program with moderately difficult challenge activities. | Behavioural | TBH Brain Workout 2.0 |
| TBH Memory 1.0TBH Memory program with easy challenge activities. | Behavioural | TBH Memory 1.0 |
| TBH Memory 2.0TBH Memory program with moderately difficult challenge activities | Behavioural | TBH Memory 2.0 |
Primary outcome
Brain Health Fund of Knowledge Questionnaire
Time frame: 2 months
Test of knowledge of lifestyle factors that improve brain health, ranging from 0 to 30 with a higher score representing better knowledge.
Memory Controllability Inventory: Potential for Improvement (Lachman, 1995)
Time frame: 2 months
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.
5 secondary outcomes
TBH Brain Workout Groups: Center for Epidemiological Survey-Depression (Radloff, 1977)
Time frame: 2 months
TBH Brain Workout Groups: Daily Habits Questionnaire
Time frame: 2 months
TBH Memory Groups: Multifactorial Memory Questionnaire (Troyer & Rich, 2002)
Time frame: 2 months
All Groups: Brain Health Fund of Knowledge Questionnaire
Time frame: 4 months
All Groups: Memory Controllability Inventory: Potential for Improvement (Lachman, 1995)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Background: PubMed 19413133Cornwell 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.
- Background: PubMed 25504093Deckers 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.
- Background: PubMed 18504506Hughes 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.
- BackgroundLachman, 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: PubMed 31187723Orgeta 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.
- BackgroundRadloff, 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: PubMed 29055814Rosenberg 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.
- Background: PubMed 11773220Troyer 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.
- Background: PubMed 31219687Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK542796/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.