Elucidating the Necessary Active Components of Training (ENACT)

May 4, 2022 updated by: Clemson University

Elucidating the Necessary Components and Mechanisms of Cognitive Training

Loss of independence, cognitive decline, and difficulties in everyday function are areas of great concern for older adults and their families. Cognitive training is one low cost, noninvasive training intervention that has repeatedly demonstrated reliable transfer effects to maintained cognition, everyday function, health, and most recently, a 29% reduction in incident dementia. Importantly, many of these everyday function effects are maintained across five to ten years including: maintained driving mobility, 50% reduction in at-fault vehicle crashes, and maintained Instrumental Activities of Daily Living (IADL). Although clearly an important and effective intervention, the moderators and mechanisms underlying this program are unknown.

The overall objective in this planning grant is to lay the conceptual and methodological foundation to explore cognitive, psychosocial, lifestyle behaviors, and biomarker mechanisms and moderators of two forms of conceptually driven cognitive training. Additionally, this study will examine how cognitive and psychosocial factors within daily life account for the transfer of cognitive training to everyday function. We will use a factorial design to randomize adults ages 55-85 to 0, 10, 20, 30, or 40 hours of two forms of cognitive training, a combined training, or an active comparison condition (Phase 1). An additional sample of participants will complete 20 hours of two forms of cognitive training or the active comparison group as well as provide blood samples (Phase 2).

Across the study period, participants will complete cognitive, health, lifestyle, and psychosocial assessments at baseline, posttest, and approximately three month follow-up assessments in person or remotely using a study-provided laptop. Additionally, all participants will be asked to complete daily cognitive, health, lifestyle, and psychosocial measures daily using study-provided smartphones.

This study will allow us to test the feasibility of our enrollment, assessment and training protocols for a future multisite clinical trial. This exploratory study is the first of its kind and will be used to provide important data relevant to a future larger randomized controlled trial examining mediators of cognitive training in a representative sample of adults. This information will assist in the future development of more effective home- and community-based interventions that maintain everyday function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Clemson University Institute for Engaged Aging
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Phase 1:

    • Age 55-85 community-dwelling adults
    • Written informed consent obtained
    • No reported evidence of or diagnosis of dementia/Alzheimer's Disease; score of 5 or greater on the MIS-t administered during phone screening
    • Willing and able to participate in the up to 9 months of the study duration
    • Is proficient in written and spoken English

  • Phase 2:

    • All Phase 1 criteria plus willingness and ability to provide two blood samples at baseline and posttest

Exclusion Criteria:

  • Phase 1 exclusions:

    • Failure to meet any of the above eligibility criteria
    • Use of video games for more than 2 hours/week over the previous 2 years
    • Currently engaged in a cognitive program such as Brain HQ or Lumosity
  • Phase 2 exclusion:

In addition to Phase 1 exclusion, also criteria below:

• Inability or unwillingness to travel to Clemson to provide two in-person blood samples at baseline and posttest

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No contact
0 hours of activities during intervention period of study
Experimental: TDD1
10 hours of top-down driven cognitive training games
Behavioral: TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Experimental: TDD2
10 hours of top-down driven cognitive training games
Behavioral: TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
Experimental: TDD1 + TDD2
20 hours of top-down driven cognitive training games
Behavioral: TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Behavioral: TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
Experimental: BUD1
10 hours of bottom-up driven cognitive training games
Behavioral: BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Experimental: BUD2
10 hours of bottom-up driven cognitive training games
Behavioral: BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Experimental: BUD1 + BUD2
20 hours of bottom-up driven cognitive training games
Behavioral: BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Behavioral: BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Experimental: BUD2 + TDD2
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Behavioral: TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
Behavioral: BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Experimental: BUD1 + TDD1
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Behavioral: TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Behavioral: BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Experimental: BUD2 + TDD1
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Behavioral: TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Behavioral: BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Experimental: BUD2 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Behavioral: TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Behavioral: TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
Behavioral: BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Experimental: BUD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Behavioral: TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
Behavioral: BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Experimental: BUD1 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Behavioral: TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Behavioral: TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
Behavioral: BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Experimental: BUD1 + BUD2 + TDD2
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Behavioral: TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
Behavioral: BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Behavioral: BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Experimental: BUD1 + BUD2 + TDD1
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Behavioral: TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Behavioral: BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Behavioral: BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Experimental: BUD1 + BUD2 + TDD1 + TDD2
20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Behavioral: TDD1
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Behavioral: TDD2
10 hours of top-down driven computerized cognitive training designed to improve executive function
Behavioral: BUD1
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Behavioral: BUD2
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Active Comparator: CSA10
10 hours of cognitive stimulating activities
Behavioral: CSA10
10 hours of computerized games
Active Comparator: CSA20
20 hours of cognitive stimulating activities
Behavioral: CSA20
20 hours of computerized games
Active Comparator: CSA30
30 hours of cognitive stimulating activities
Behavioral: CSA30
30 hours of computerized games
Active Comparator: CSA40
40 hours of cognitive stimulating activities
Behavioral: CSA40
40 hours of computerized games

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protocol compliance
Time Frame: Baseline through 3 month follow-up visit
Participants complete laptop and phone activities as outlined in the study protocol
Baseline through 3 month follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complex Instrumental Activities of Daily Living
Time Frame: Baseline through 3 month follow-up visit
Measures of everyday functioning as detailed in the study protocol
Baseline through 3 month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clemson University

Collaborators

University of Alabama at Birmingham
National Institute on Aging (NIA)
Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2022

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01AG062370 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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