NCT02969460

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

November 30, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

November 17, 2016

Last Update Submit

October 9, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • RBANS score

    Repeatable Battery for the Assessment of Neuropsychological Status total score

    week 24

  • RBANS score

    Repeatable Battery for the Assessment of Neuropsychological Status total score

    week 52

Secondary Outcomes (4)

  • PHQ-9

    week 24

  • PHQ-9

    week 52

  • GAD-7

    week 24

  • GAD-7

    week 52

Study Arms (1)

Neurotrack Virtual Cognitive Health Program

EXPERIMENTAL

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

Interventions

Neurotrack Virtual Cognitive Health Program

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidation Health

San Mateo, California, 94401, United States

Location

Related Publications (2)

  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

November 30, 2016

Primary Completion

April 18, 2018

Study Completion

April 18, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations