Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04822129 |
| Other study ID # |
Pending |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 26, 2021 |
| Est. completion date |
March 31, 2022 |
Study information
| Verified date |
July 2023 |
| Source |
Nova Southeastern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a research study, designed to test and create new ideas that other people can use.
The purpose of this research study is to evaluate two ways of helping people learn to keep
their brain healthy. Research has shown that things like exercise, diet, and computer-based
cognitive training (doing things that make you think and remember on a computer or tablet)
may help older persons maintain their mental functioning as they get older. We want to look
at two ways for people to a develop brain healthy lifestyle that they can use and even enjoy.
If we find that one of the ways of developing a brain healthy lifestyle is better than the
other, other older persons may be able to use it, too. When we say "brain healthy lifestyle,"
we mean doing things that help to keep you healthy, like exercising and following a good
diet. We also mean doing things that may help you think better and maintain your thinking and
reasoning as you get older.
Description:
Overview: Participants will complete a baseline battery of self-report and cognitive measures
before and after 12 weeks of weekly videoconferences and diaries of brain health-related
activities completed during weeks 1, 6, and 12. They will be randomly assigned to one of two
groups: (1) treatment as usual (TAU), in which they will receive basic information about a
brain healthy lifestyle (topics such as diet, exercise, computer-based cognitive training,
meditation as well as others) and encouraged to develop a brain-health lifestyle or (2) an
intervention based on the Cogtrastim model combined with behavior change support. This model
posits that brain healthy lifestyle should encompass activities focused on one of three basic
mechanisms related to brain health. Model-based activity choices will be integrated with an
intensive behavior change intervention focused on realistic goal setting, self-monitoring,
problem solving barriers to behavior change, and developing strategies for behavior
maintenance.
Rationale for TAU: The intervention to be used in the treatment as usual group is a
reasonable representation of what many older persons face in finding out about the importance
of brain health, selecting from the broad range of potential brain health activities, and
changing their health-related behaviors. A great deal of information is available online and
in books. Many models of programs for brain health recommend multiple activities or
interventions with little guidance on selection or prioritizing them. The TAU intervention
will mirror this situation, providing participants with multiple resources from which to
choose activities and methods of behavior change.
Baseline assessment: After completion of the informed consent interview and the participants
have given consent to be involved in study procedures, the researchers will complete an
interview with participants focused on medication use, health status, and demographic
information. They will then be given links to self-report questionnaires on RedCap and sent
an invitation e-mail to complete a cognitive assessment on the Cognifit website.
Measures will include the Memory Self-Efficacy Scale, Alzheimer Disease Risk Inventory
(ADRI), Perceived Stress Scale, Dementia Knowledge Assessment Scale, risk subscale, PROMIS
Cognitive Function, Self-Report Measure of Cognitive Abilities, Technology Use Questionnaire,
and the NIH Toolbox General Life Satisfaction Questionnaire.
Cognifit assessment: This is a commercially-available product previously used in studies of
computer-based cognitive training in older adults. The Cognitive Assessment Battery for
People Over 55 (CAB-AG) requires 20 to 30 minutes and measures various mental abilities as
well as briefly assessing mental well-being. It is a standard commercially-available product.
It provides a general score as well as subscores in domains of reasoning, memory, attention,
coordination, and perception.
INTERVENTIONS
Intervention for TAU group: Actual participation in the intervention will begin with the
first videoconference. The general format for each conference will be a brief presentation
(10-15 minutes) by a researcher on a specific topic related to brain health, with the
remainder of the time spent in discussion of the topic's importance and in answering
participants' questions about the topic or about any other concerns they have related to
developing a brain healthy lifestyle. The first videoconference will also provide
participants with an overview of the daily log form, instructions for completing it and
entering results every week in RedCap, and a reminder on the process of compensation for
completion of the logs.
Intervention for Cogtrastim group: The study intervention for this group will include a
review of the Cogtrastim model and explicit discussion of the possible mechanisms of action
of various activities that have been shown to be associated with better health in general
and, where supported by evidence, better mental functioning in older persons. Persons in this
group will be encouraged to select brain health activities based on the model. Early
videoconference sessions will also focus on strategies for behavior change, including
realistic goal setting, problem solving about possible difficulties, and assistance in
formulating a written plan to improve brain health. Participants will be encouraged to
develop a written program for brain health and to also develop self-monitoring habits.
All participants will be given access to the study website at www.sfbrainhealth.com which
will serve as a compendium of links to relevant and reviewed brain health resources (e.g.,
links to material on older adults and exercise on the websites of the Centers for Disease
Control and the National Institute on Aging).
All participants will be asked to complete a baseline assessment (RedCap questionnaires and
Cognifit cognitive assessment) prior to participating in any other study procedures. They
will be asked to complete a daily study diary of their training activities for seven days in
weeks one, six, and 12 of the study. They will be given access to the Cognifit training
activities after completion of the baseline assessments.
Cognifit training program: The Cognifit training program is based on an automated algorithm
that selects a variety of activities based on the participant's strengths and weaknesses as
well as their training history. At a summary level, Cognifit identifies which cognitive
abilities (of those covered in the applied training) are most in need of improvement, and how
long it has been since a cognitive ability has been trained. When, based on a series of
weightings of these variables, it is decided which cognitive capacity is to be trained, the
system checks which activities best train these cognitive capacities and how long it has been
since they were trained. In this way, the system ensures that training focuses heavily on the
cognitive abilities (and consequently on the tasks) that the user needs to train the most,
but without forgetting to continue training the cognitive abilities that the user has in good
condition.
Participants in both groups will be given access to weekly videoconferences brain health
topics and encouraged to develop a plan to improve their brain health during the 12 weeks of
the study. At the conclusion of this period, participants will be asked to complete the same
battery of measures they had completed at the beginning with the addition of a questionnaire
asking for ratings of the study interventions. They will be scheduled for an exit interview
during which a semi-structured interview outline will be used to assess participants'
reactions to the study and elicit their suggestions for improving future versions.
