search
Back to results

Neurotrack Virtual Cognitive Health Study

Primary Purpose

Subjective Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurotrack Virtual Cognitive Health Program
Sponsored by
Evidation Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Subjective Cognitive Decline

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Evidation Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurotrack Virtual Cognitive Health Program

Arm Description

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.

Outcomes

Primary Outcome Measures

RBANS score
Repeatable Battery for the Assessment of Neuropsychological Status total score
RBANS score
Repeatable Battery for the Assessment of Neuropsychological Status total score

Secondary Outcome Measures

PHQ-9
Patient-health questionnaire 9-item scale
PHQ-9
Patient-health questionnaire 9-item scale
GAD-7
Generalized anxiety disorder 7-item scale
GAD-7
Generalized anxiety disorder 7-item scale

Full Information

First Posted
November 17, 2016
Last Updated
October 9, 2018
Sponsor
Evidation Health
Collaborators
Neurotrack
search

1. Study Identification

Unique Protocol Identification Number
NCT02969460
Brief Title
Neurotrack Virtual Cognitive Health Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evidation Health
Collaborators
Neurotrack

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurotrack Virtual Cognitive Health Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neurotrack Virtual Cognitive Health Program
Primary Outcome Measure Information:
Title
RBANS score
Description
Repeatable Battery for the Assessment of Neuropsychological Status total score
Time Frame
week 24
Title
RBANS score
Description
Repeatable Battery for the Assessment of Neuropsychological Status total score
Time Frame
week 52
Secondary Outcome Measure Information:
Title
PHQ-9
Description
Patient-health questionnaire 9-item scale
Time Frame
week 24
Title
PHQ-9
Description
Patient-health questionnaire 9-item scale
Time Frame
week 52
Title
GAD-7
Description
Generalized anxiety disorder 7-item scale
Time Frame
week 24
Title
GAD-7
Description
Generalized anxiety disorder 7-item scale
Time Frame
week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Evidation Health
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31518248
Citation
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.
Results Reference
derived
PubMed Identifier
30104186
Citation
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.
Results Reference
derived

Learn more about this trial

Neurotrack Virtual Cognitive Health Study

We'll reach out to this number within 24 hrs