The Everyday Function Intervention Trial

NCT04651582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-10-02

No results posted yet for this study

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

Interventions

BEHAVIORAL

Cognitive Training

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

BEHAVIORAL

Cognitive Stimulating Activities

20 hours of traditional computer games

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Clemson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2022-10-27
Completion
2022-10-27

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04651582 on ClinicalTrials.gov