Older Persons Interested in Improving Their Brain HealthNCT04822129
A Comparison of Two Approaches to Developing Brain Health Programs
A study testing Treatment as Usual and Cogtrastim Model in people with Older Persons Interested in Improving Their Brain Health, run by Nova Southeastern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Persons Interested in Improving Their Brain Health
- What is being tested?
- Treatment as Usual and Cogtrastim Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 31 Mar 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential participants will be community-dwelling persons 50 years of age and older who are interested in developing a more brain healthy lifestyle and are willing to participate in a 12-week study of brain health. They must have access to a stable internet connection that will allow them to communicate with the researchers by e-mail, complete online assessments and cognitive training, and participate in videoconferences.
Who cannot join
- Persons who are not community dwelling (i.e., do not live independently) as persons in a nursing facility will not be eligible, however, persons who live independently in a facility that provides a range of support will be eligible. If, in the course of the informed consent process, it appears that the person does not have the ability to provide meaningful informed consent, they will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Collaborative Research, Nova Southeastern University
Fort Lauderdale, Florida, 33314
About this study
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.
Read the detailed 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.
- Being tested
- Treatment as Usual, Cogtrastim Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as UsualBehavioural
Also called TAU
Treatment as usual will provide participants with basic information that is readily available as well as the encouragement to develop a brain health program that may be available from medical professionals.
Cogtrastim ModelBehavioural
Also called Cogtrastim
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | 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 Dr. Ownby 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. Receives: Behavioral: Treatment as Usual |
| Cogtrastim model | Experimental | 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. Receives: Behavioral: Cogtrastim Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Australian National University Alzheimer's Disease Risk Index (ANU-ADRI)
A composite measure of personal characteristics related to risk for cognitive decline in older persons. Scores range from 0 to 76 with higher scores indicating higher exposures to risk factors for dementia.
Measured: Three months
Secondary outcomes (2)
Memory Self Efficacy Scale
A brief measure of how participants feel about their memory functioning. Scores range from 10 to 70, with higher scores indicating self-report of fewer memory problems (better memory functioning).
Measured: Three months
Dementia Knowledge Scale, Risk subscale
A brief assessment of lifestyle factors related to risk for developing dementia. Scores range from 0 to 6, with higher scores indicating greater knowledge of risk factors for dementia.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start26 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older Persons Interested in Improving Their Brain HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Ownby, M.D., Nova Southeastern University
- Investigators
- Raymond L Ownby, MD, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822129
- Sponsor's protocol ID
- Pending
- Status last verified
- Jul 2023
- First submitted
- 26 Mar 2021
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available to qualified researchers.
Publications
Ownby RL, Davenport R. An Online Shared Decision-making Intervention for Dementia Prevention: A Parallel-group Randomized Pilot Study. Curr Alzheimer Res. 2023;20(8):577-587. doi: 10.2174/0115672050274126231120112158.
PubMed 38047365
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Approaches to Developing Brain Health Programs
- ClinicalTrials.gov ID
- NCT04822129
- Acronym / sponsor ID
- Pending
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 30 Mar 2021 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Treatment as UsualIntervention 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 Dr. Ownby 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. |
| Cogtrastim model | Experimental | Behavioral: Cogtrastim ModelThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Potential participants will be community-dwelling persons 50 years of age and older who are interested in developing a more brain healthy lifestyle and are willing to participate in a 12-week study of brain health. They must have access to a stable internet connection that will allow them to communicate with the researchers by e-mail, complete online assessments and cognitive training, and participate in videoconferences.
Key exclusion criteria (1 listed)
- Persons who are not community dwelling (i.e., do not live independently) as persons in a nursing facility will not be eligible, however, persons who live independently in a facility that provides a range of support will be eligible. If, in the course of the informed consent process, it appears that the person does not have the ability to provide meaningful informed consent, they will be excluded.
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 |
|---|---|---|
| Treatment as UsualAlso: TAUTreatment as usual will provide participants with basic information that is readily available as well as the encouragement to develop a brain health program that may be available from medical professionals. | Behavioural | Treatment as usual |
| Cogtrastim ModelAlso: CogtrastimThe 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. | Behavioural | Cogtrastim model |
Primary outcome
Australian National University Alzheimer's Disease Risk Index (ANU-ADRI)
Time frame: Three months
A composite measure of personal characteristics related to risk for cognitive decline in older persons. Scores range from 0 to 76 with higher scores indicating higher exposures to risk factors for dementia.
2 secondary outcomes
Memory Self Efficacy Scale
Time frame: Three months
Dementia Knowledge Scale, Risk subscale
Time frame: Three months
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 11 Jul 2023.
- Derived from this study: PubMed 38047365Ownby RL, Davenport R. An Online Shared Decision-making Intervention for Dementia Prevention: A Parallel-group Randomized Pilot Study. Curr Alzheimer Res. 2023;20(8):577-587. doi: 10.2174/0115672050274126231120112158.
- Study website with links to brain health information.Link provided by the sponsor.
- Page on study website with study flyer and contact form.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be made available to qualified researchers.
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.
Raymond L Ownby, MD, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as Usual and Cogtrastim Model in people with Older Persons Interested in Improving Their Brain Health, run by Nova Southeastern 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 11 Jul 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?
Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04822129, which also lists 1 linked publication.
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 11 Jul 2023.