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

  • United States
    • California
      • San Mateo, California, United States, 94401
        • Evidation Health

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.
Behavioral: Neurotrack Virtual Cognitive Health Program

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
week 24
RBANS score
Time Frame: week 52
Repeatable Battery for the Assessment of Neuropsychological Status total score
week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ-9
Time Frame: week 24
Patient-health questionnaire 9-item scale
week 24
PHQ-9
Time Frame: week 52
Patient-health questionnaire 9-item scale
week 52
GAD-7
Time Frame: week 24
Generalized anxiety disorder 7-item scale
week 24
GAD-7
Time Frame: week 52
Generalized anxiety disorder 7-item scale
week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidation Health

Collaborators

Neurotrack

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

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.

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