- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969460
Neurotrack Virtual Cognitive Health Study
October 9, 2018 updated by: Evidation Health
The Neurotrack Virtual Cognitive Health Study is a 12-month long, prospective study that aims to evaluate the impact of the Neurotrack Virtual Cognitive Health Coaching Program on cognitive ability, anxiety and depression, and lifestyle behaviors for individuals who show signs of subjective cognitive decline.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Mateo, California, United States, 94401
- Evidation Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 60-75
- Individuals who show signs of subjective cognitive decline (assessed by scoring ≥ 1 on the Subjective Cognitive Decline [Short Form] Questionnaire and endorsing the Personal Worry Item on the questionnaire)
- Have the ability to make and receive phone calls
- Have the ability to send and receive text messages
- Access to a desktop computer, video-teleconferencing and reliable internet connection
- Motivated to use a daily coaching program
Exclusion Criteria:
- Significant history of mental illness, substance abuse, learning disability, or neurologic conditions
- History of dementia
- Ophthalmologic/visual problems that prevent individual from viewing a computer screen at a normal distance (e.g., legal blindness, detached retinas, occlusive cataracts)
- Currently participating in a formal cognitive-training coaching program
- Currently pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neurotrack Virtual Cognitive Health Program
This program is a multi-domain lifestyle intervention designed to prevent or delay cognitive decline and impairment in older at-risk adults.
The first 6 months of the program emphasizes lifestyle change, while the last 6 months of the program emphasizes habit reinforcement.
The program focuses on nutrition, physical exercise, and cognitive training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RBANS score
Time Frame: week 24
|
Repeatable Battery for the Assessment of Neuropsychological Status total score
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week 24
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RBANS score
Time Frame: week 52
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Repeatable Battery for the Assessment of Neuropsychological Status total score
|
week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PHQ-9
Time Frame: week 24
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Patient-health questionnaire 9-item scale
|
week 24
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PHQ-9
Time Frame: week 52
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Patient-health questionnaire 9-item scale
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week 52
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GAD-7
Time Frame: week 24
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Generalized anxiety disorder 7-item scale
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week 24
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GAD-7
Time Frame: week 52
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Generalized anxiety disorder 7-item scale
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week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kumar S, Tran J, Moseson H, Tai C, Glenn JM, Madero EN, Krebs C, Bott N, Juusola JL. The Impact of the Virtual Cognitive Health Program on the Cognition and Mental Health of Older Adults: Pre-Post 12-Month Pilot Study. JMIR Aging. 2018 Nov 9;1(2):e12031. doi: 10.2196/12031.
- Bott N, Kumar S, Krebs C, Glenn JM, Madero EN, Juusola JL. A Remote Intervention to Prevent or Delay Cognitive Impairment in Older Adults: Design, Recruitment, and Baseline Characteristics of the Virtual Cognitive Health (VC Health) Study. JMIR Res Protoc. 2018 Aug 13;7(8):e11368. doi: 10.2196/11368.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2016
Primary Completion (Actual)
April 18, 2018
Study Completion (Actual)
April 18, 2018
Study Registration Dates
First Submitted
November 17, 2016
First Submitted That Met QC Criteria
November 17, 2016
First Posted (Estimate)
November 21, 2016
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
October 9, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EH-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subjective Cognitive Decline
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Beijing Hospital of Traditional Chinese MedicineUnknownSubjective Cognitive Decline | Subjective Cognitive ComplaintChina
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University of WaterlooUniversity of Ottawa; Baycrest; Université de MontréalRecruiting
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Vanderbilt University Medical CenterNot yet recruiting
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Indiana UniversityNational Institute on Aging (NIA)CompletedSubjective Cognitive DeclineUnited States
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Centre de Recherche de l'Institut Universitaire...Canadian Institutes of Health Research (CIHR); Rotman Research Institute at...Active, not recruitingSubjective Cognitive DeclineCanada
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BaycrestCompletedSubjective Cognitive DeclineCanada
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Vanderbilt University Medical CenterRecruiting
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IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity of ChietiCompletedSubjective Cognitive DeclineItaly
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National Cheng Kung UniversityUnknownEffects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive DeclineSubjective Cognitive DeclineTaiwan
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University Hospital TuebingenCompletedSubjective Cognitive DeclineGermany
Clinical Trials on Neurotrack Virtual Cognitive Health Program
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Badalona Serveis AssistencialsPublic Health Agency of Barcelona; Reality Telling SLCompletedCognitive Dysfunction | Mild Cognitive ImpairmentSpain
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University of Massachusetts, LowellSpaulding Rehabilitation Hospital; Hugo W. Moser Research Institute at Kennedy...Recruiting
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Mackay Medical CollegeTri-Service General Hospital; National Defense Medical Center, TaiwanCompletedMental Health Issue
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Icahn School of Medicine at Mount SinaiActive, not recruiting
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Lady Davis InstituteNot yet recruitingCognitive Decline | Depression in Old Age
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University of DenverStanford University; University of Colorado, BoulderCompletedMajor Depressive Disorder | RecurrentUnited States
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Lady Davis InstituteSuspendedDepression Anxiety DisorderCanada
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Philadelphia College of Osteopathic MedicineNational Institutes of Health (NIH)Not yet recruitingObesity
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University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)CompletedMajor Depressive DisorderUnited States
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Stockholm UniversityPBM; MimerseCompletedSocial Anxiety | Public Speaking | Social Anxiety Disorder, Performance OnlySweden