The Everyday Function Intervention Trial

NCT04651582 | Completed

• 1 other identifier: R21AG060216
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cognitive Change; Cognitive Impairment; Healthy Aging; Dementia

Keywords

Brain training; Cognitive training; Brain health; Everyday functioning

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  Baseline and Immediate Post-test at 14 weeks

Study Arms (2)

Cognitive Training

EXPERIMENTAL

20 hours of computerized brain exercises

Behavioral: Cognitive Training

Cognitively Stimulating Activities

ACTIVE COMPARATOR

20 hours of computerized brain exercises

Behavioral: Cognitive Stimulating Activities

Interventions

Cognitive Training BEHAVIORAL

20 hours of computerized activities designed to improve processing speed and divided attention

Cognitive Training

Cognitive Stimulating Activities BEHAVIORAL

20 hours of traditional computer games

Cognitively Stimulating Activities

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Clemson University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The Pennsylvania State University

State College, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 3, 2020
• Study Start: January 5, 2021
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)