Cognitive ChangeEFITNCT04651582
The Everyday Function Intervention Trial
A study testing Cognitive Training and Cognitive Stimulating Activities in people with Cognitive Change and Cognitive Impairment, run by Clemson University at 1 site in United States.
Trial summary
Loss of independence, cognitive decline, and difficulties in everyday function are areas of great concern for older adults and their families. From a public health perspective, successful efforts that enable older adults to age within their homes, as compared to nursing homes, will save an estimated $80 billion… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Cognitive Impairment, Healthy Aging
- What is being tested?
- Cognitive Training and Cognitive Stimulating Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 27 Oct 2022
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
- Community-dwelling adults aged 65 to 90
- Ability to understand and communicate with written and spoken English
- No reported diagnosis or evidence of Alzheimer 's disease or other dementia; score of 5 or greater on the MIS-t administered during phone screening
- Able and willing to complete the 6 month protocol
- Not currently engaged in cognitive program
- No use of video games for more than 2 hours/week over the previous 2 years
- No plans to have travel outside of the US in the next 6 months
Additional criteria for MRI/sleep (in addition to the above criteria for EFIT):
- Willing to undergo an MRI of the brain two times during the EFIT study
- Be able to lie flat on the MRI table in a supine position for at least 60 minutes
- Pass the standard IRB-approved SELIC MRI-safety screening criteria (see MRI screen SELIC in CATS)
- Willing to use the study-provided Sleep Profiler for 2 nights twice during the study
- Willing to wear a study-provided FitBit throughout the study
- No pregnant or breast feeding
- Must be right handed
- Must have sufficient vision to see ANT task without glasses
- No contraindication to MRI per standard MRI safety screening
- No persons with significant claustrophobia
- No open wound on the scalp or forehead
- No allergy to extended exposure to synthetic fabrics, such as polyester or rayon
- No head tremors or tics
- No persons currently using any of the following: opioids, stimulants, or recreational drugs
- No medication changes in the past 2 weeks in anxiety or depression medications
- No medication changes in the past 2 months for sleep disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
State College, Pennsylvania, 16802
About this study
Official title: Assessing Cognitive and Psychosocial Mechanisms of Useful Field of View Cognitive Training Using Ecological Momentary Assessment
Loss of independence, cognitive decline, and difficulties in everyday function are areas of great concern for older adults and their families. From a public health perspective, successful efforts that enable older adults to age within their homes, as compared to nursing homes, will save an estimated $80 billion dollars per year. Cognitive training is one intervention that maintains cognition, everyday function, and health. Although clearly an important and effective intervention, the mediators, or mechanisms, underlying this program are unknown. Our overall objective is to assess the cognitive and psychosocial factors within daily life that account for the transfer of one form of cognitive training to everyday function. This exploratory double-blind trial will randomize older adults to 20 hours of cognitive training or cognitively stimulating activities. The investigators will assess cognitive and psychosocial factors before, during, and after training within daily life. The investigators will then compare such factors and assess how they impact the transfer of cognitive training to everyday functioning. The investigators will also include an eligible sub group of the EFIT participants who will have functional MRI brain scans and sleep evaluation using the Sleep Profiler, a clinically approved device, at pre and post brain training. The investigators will also monitor daily activity in this sub group using FitBIt watches.
Our central hypothesis is that improvements in daily processing speed and attention, key components of higher order cognitive functions, will have the strongest relationship with everyday function changes. 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. Additionally, all data collection, with the exception of MRI, can be completed remotely within the participant's home. This information will assist in the future development of more effective home- and community-based interventions that maintain everyday function.
Read the detailed description
The EFIT study is a randomized clinical trial to explore moderators and mechanisms underlying the transfer of one cognitive training program to maintained cognition and everyday function. 100 participants will complete three traditional assessments of cognitive, psychosocial, and lifestyle assessments on a study-provided laptop at baseline, post-test, and three-month follow-up. Across this study period, participants will complete daily cognitive, psychosocial, and health assessments using a study-provided smartphone. Between baseline and post-test, participants will be randomized to one of two arms: cognitive training or an active control. Both groups will complete 20 hours of activities on the study-provided laptop across a ten week period.
A subsample of 40 participants will also complete three additional measures. First, they will be provided a FitBit and be asked to wear the FitBit across the study period. Second, sleep measures will be obtained across two nights at baseline and post-test using an at home sleep monitor, which is clinically approved, and evaluated by a physician specializing in sleep. Finally, this subsample will also complete a fMRI session at baseline and posttest.
Except for the fMRI sessions, all data collection is complete remotely within the participants' homes.
- Conditions
- Cognitive Change, Cognitive Impairment, Healthy Aging, Dementia
- Being tested
- Cognitive Training, Cognitive Stimulating Activities
- Keywords
- Brain training, Cognitive training, Brain health, Everyday functioning
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
20 hours of computerized activities designed to improve processing speed and divided attention
Cognitive Stimulating ActivitiesBehavioural
20 hours of traditional computer games
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | 20 hours of computerized brain exercises Receives: Behavioral: Cognitive Training |
| Cognitively Stimulating Activities | Active comparator | 20 hours of computerized brain exercises Receives: Behavioral: Cognitive Stimulating Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Useful Field of View (UFOV) test at 14 and 26 weeks
This computerized assessment includes four subtests assessing processing speed, divided attention and selective attention scored in ms.
Measured: Baseline, Immediate Post-test at 14 weeks, and 3 month follow-up at 26 weeks
Change from Baseline Daily Everyday Cognitive Assessment (DECA) at 14 and 26 weeks
This computerized task assesses everyday function across simulated everyday tasks of medical, nutrition, and problem solving tasks. Task accuracy and speed are recorded.
Measured: Baseline, Immediate Post-test at 14 weeks, and 3 month follow-up at 26 weeks
Change from Baseline iFunction at 14 and 26 weeks
This computerized task assesses everyday function across simulated everyday tasks of medical, travel, and communication tasks. An overall score reflecting time and accuracy (i.e., efficiency index) is calculated to reflect performance across the ifunction subtests the proprietary software determines the score. Higher scores are better for efficiency index.
Measured: Baseline, Immediate Post-test at 14 weeks, and 3 month follow-up at 26 weeks
Secondary outcomes (1)
Change from Baseline Objective sleep at 14 weeks
The sleep profiler monitor is a proprietary FDA approved ambulatory sleep EEG device designed for in-home sleep architecture monitoring. The Profiler will provide sleep spindle data in seconds, a pertinent sleep characteristic linked to memory and learning as well as computer brain training. Sleep spindles are an EEG hallmark of non-rapid eye movement (NREM) and are typically clinically classified as bursts of synchronous ~12-15 Hz neuronal firing in thalamocortical networks.
Measured: Baseline and Immediate Post-test at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start5 Jan 2021
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lesley A. Ross, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651582
- Sponsor's protocol ID
- R21AG060216
- Other IDs
- R21AG060216
- Acronym
- EFIT
- Status last verified
- Sep 2023
- First submitted
- 18 Nov 2020
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cognitive and Psychosocial Mechanisms of Useful Field of View Cognitive Training Using Ecological Momentary Assessment
- ClinicalTrials.gov ID
- NCT04651582
- Acronym / sponsor ID
- EFIT / R21AG060216
- Conditions
- Cognitive Change, Cognitive Impairment, Healthy Aging, Dementia
- Keywords
- Brain training, Cognitive training, Brain health, Everyday functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 3 Dec 2020 (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.
Loss of independence, cognitive decline, and difficulties in everyday function are areas of great concern for older adults and their families. From a public health perspective, successful efforts that enable older adults to age within their homes, as compared to nursing homes, will save an estimated $80 billion dollars per year. Cognitive training is one intervention that maintains cognition, everyday function, and health. Although clearly an important and effective intervention, the mediators, or mechanisms, underlying this program are unknown. Our overall objective is to assess the cognitive and psychosocial factors within daily life that account for the transfer of one form of cognitive training to everyday function. This exploratory double-blind trial will randomize older adults to 20 hours of cognitive training or cognitively stimulating activities. The investigators will assess cognitive and psychosocial factors before, during, and after training within daily life. The investigators will then compare such factors and assess how they impact the transfer of cognitive training to everyday functioning. The investigators will also include an eligible sub group of the EFIT participants who will have functional MRI brain scans and sleep evaluation using the Sleep Profiler, a clinically approved device, at pre and post brain training. The investigators will also monitor daily activity in this sub group using FitBIt watches.
Our central hypothesis is that improvements in daily processing speed and attention, key components of higher order cognitive functions, will have the strongest relationship with everyday function changes. 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. Additionally, all data collection, with the exception of MRI, can be completed remotely within the participant's home. This information will assist in the future development of more effective home- and community-based interventions that maintain everyday function.
Detailed description
The EFIT study is a randomized clinical trial to explore moderators and mechanisms underlying the transfer of one cognitive training program to maintained cognition and everyday function. 100 participants will complete three traditional assessments of cognitive, psychosocial, and lifestyle assessments on a study-provided laptop at baseline, post-test, and three-month follow-up. Across this study period, participants will complete daily cognitive, psychosocial, and health assessments using a study-provided smartphone. Between baseline and post-test, participants will be randomized to one of two arms: cognitive training or an active control. Both groups will complete 20 hours of activities on the study-provided laptop across a ten week period.
A subsample of 40 participants will also complete three additional measures. First, they will be provided a FitBit and be asked to wear the FitBit across the study period. Second, sleep measures will be obtained across two nights at baseline and post-test using an at home sleep monitor, which is clinically approved, and evaluated by a physician specializing in sleep. Finally, this subsample will also complete a fMRI session at baseline and posttest.
Except for the fMRI sessions, all data collection is complete remotely within the participants' homes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive Training20 hours of computerized brain exercises |
| Cognitively Stimulating Activities | Active comparator | Behavioral: Cognitive Stimulating Activities20 hours of computerized brain exercises |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Cognitive Training20 hours of computerized activities designed to improve processing speed and divided attention | Behavioural | Cognitive Training |
| Cognitive Stimulating Activities20 hours of traditional computer games | Behavioural | Cognitively Stimulating Activities |
Primary outcome
Change from Baseline Useful Field of View (UFOV) test at 14 and 26 weeks
Time frame: Baseline, Immediate Post-test at 14 weeks, and 3 month follow-up at 26 weeks
This computerized assessment includes four subtests assessing processing speed, divided attention and selective attention scored in ms.
Change from Baseline Daily Everyday Cognitive Assessment (DECA) at 14 and 26 weeks
Time frame: Baseline, Immediate Post-test at 14 weeks, and 3 month follow-up at 26 weeks
This computerized task assesses everyday function across simulated everyday tasks of medical, nutrition, and problem solving tasks. Task accuracy and speed are recorded.
Change from Baseline iFunction at 14 and 26 weeks
Time frame: Baseline, Immediate Post-test at 14 weeks, and 3 month follow-up at 26 weeks
This computerized task assesses everyday function across simulated everyday tasks of medical, travel, and communication tasks. An overall score reflecting time and accuracy (i.e., efficiency index) is calculated to reflect performance across the ifunction subtests the proprietary software determines the score. Higher scores are better for efficiency index.
1 secondary outcome
Change from Baseline Objective sleep at 14 weeks
Time frame: Baseline and Immediate Post-test at 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training and Cognitive Stimulating Activities in people with Cognitive Change and Cognitive Impairment, run by Clemson University 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?
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: finished, as of the sponsor's last update on 2 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Useful Field of View (UFOV) test at 14 and 26 weeks (time frame: Baseline, Immediate Post-test at 14 weeks, and 3 month follow-up at 26 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2023.