Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ACAR Brain Health Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208880
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ian M. McDonough, University of Alabama, Tuscaloosa

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.

Condition or disease Intervention/treatment Phase
Aging Well Behavioral: TBH Brain Workout 1.0 Behavioral: Brain Health Book Club Behavioral: TBH Brain Workout 2.0 Behavioral: TBH Memory 1.0 Behavioral: TBH Memory 2.0 Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of six groups in parallel for the duration of the study.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ACAR Brain Health Intervention Study: A Preliminary Investigation of Subjective Memory and Well-Being
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: 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.
Behavioral: TBH Brain Workout 1.0
TBH Brain Workout program with easy challenge activities.

Experimental: 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.
Behavioral: TBH Brain Workout 2.0
TBH Brain Workout program with moderately difficult challenge activities.

Experimental: 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.
Behavioral: TBH Memory 1.0
TBH Memory program with easy challenge activities.

Experimental: 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.
Behavioral: TBH Memory 2.0
TBH Memory program with moderately difficult challenge activities

Active Comparator: 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.
Behavioral: Brain Health Book Club
Each week a new chapter will be read that contains new information to enhance brain health.

No Intervention: No Contact Wait List
The Wait List group will simply take the the surveys at each time point as the other groups.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. TBH Brain Workout Groups: Center for Epidemiological Survey-Depression (Radloff, 1977) [ Time Frame: 2 months ]
    Self-reported assessment of depressive symptoms, ranging from 0 to 60 where higher scores indicate more depression.

  2. TBH Brain Workout Groups: Daily Habits Questionnaire [ Time Frame: 2 months ]
    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.

  3. TBH Memory Groups: Multifactorial Memory Questionnaire (Troyer & Rich, 2002) [ Time Frame: 2 months ]
    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.

  4. All Groups: Brain Health Fund of Knowledge Questionnaire [ Time Frame: 4 months ]
    Test of knowledge of lifestyle factors that improve brain health, ranging from 0 to 30 with a higher score representing better knowledge.

  5. All Groups: Memory Controllability Inventory: Potential for Improvement (Lachman, 1995) [ Time Frame: 4 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.


Other Outcome Measures:
  1. All Groups: Modifiable Dementia Risk Questionnaire (based on Deckers et al., 2015) [ Time Frame: 2 and 4 month time points ]
    Self-report of having modifiable risk factors for dementia, ranging from -5.92 to 13.7 where higher is representative of a greater risk for dementia

  2. All Groups: Revised UCLA Loneliness Scale (Hughes et al., 2004) [ Time Frame: 2 and 4 month time points ]
    Self-report assessment of loneliness, ranging from 17 to 68 where higher numbers represent greater loneliness.

  3. All Groups: The Social Disconnectedness Scale (Cornwell et al., 2009) [ Time Frame: 2 and 4 month time points ]
    Self-report assessment of amount of social support, ranging from 9 to 36 where higher numbers represent greater social support.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 60 and older

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208880


Contacts
Layout table for location contacts
Contact: Ian M McDonough, PhD 205-737-3442 immcdonough@ua.edu
Contact: Carpantato Myles, MSM, CIM, CIP 205-348-5746 cmyles@fa.ua.edu

Locations
Layout table for location information
United States, Alabama
The University of Alabama Recruiting
Tuscaloosa, Alabama, United States, 35487
Contact: Ian M McDonough, PhD    205-737-3442    immcdonough@ua.edu   
Sponsors and Collaborators
University of Alabama, Tuscaloosa
Publications:
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.
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.
World Health Organization. Risk reduction of cognitive decline and dementia: WHO Guidelines (2019). ISBN: 978-92-4-155054-3. https://www.who.int/mental_health/neurology/dementia/guidelines_risk_reduction/en/

Layout table for additonal information
Responsible Party: Ian M. McDonough, Assistant Professor, University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT04208880    
Other Study ID Numbers: ACARTBH
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ian M. McDonough, University of Alabama, Tuscaloosa:
Subjective Memory
Intervention
Brain Health
Educational Program
Well-being