Subjective Cognitive DeclineNCT02969460
Neurotrack Virtual Cognitive Health Study
A study testing Neurotrack Virtual Cognitive Health Program in people with Subjective Cognitive Decline, run by Evidation Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- Neurotrack Virtual Cognitive Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2016to 18 Apr 2018
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Subjective Cognitive Decline
- Being tested
- Neurotrack Virtual Cognitive Health Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotrack Virtual Cognitive Health ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Neurotrack Virtual Cognitive Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBANS score
Repeatable Battery for the Assessment of Neuropsychological Status total score
Measured: week 24
RBANS score
Repeatable Battery for the Assessment of Neuropsychological Status total score
Measured: week 52
Secondary outcomes (4)
PHQ-9
Patient-health questionnaire 9-item scale
Measured: week 24
PHQ-9
Patient-health questionnaire 9-item scale
Measured: week 52
GAD-7
Generalized anxiety disorder 7-item scale
Measured: week 24
GAD-7
Generalized anxiety disorder 7-item scale
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start30 Nov 2016
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evidation Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neurotrack
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969460
- Sponsor's protocol ID
- EH-003
- Status last verified
- Oct 2018
- First submitted
- 17 Nov 2016
- Last updated
- 12 Oct 2018
- Results posted
- No
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.
PubMed 31518248Bott 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.
PubMed 30104186
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotrack Virtual Cognitive Health Study
- ClinicalTrials.gov ID
- NCT02969460
- Acronym / sponsor ID
- EH-003
- Conditions
- Subjective Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Evidation HealthIndustry (pharma, biotech, devices)
- Collaborators
- Neurotrack
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 21 Nov 2016 (estimated)
- 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurotrack Virtual Cognitive Health Program | Experimental | Behavioral: Neurotrack Virtual Cognitive Health ProgramThis 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Neurotrack Virtual Cognitive Health Program | Behavioural | Neurotrack Virtual Cognitive Health Program |
Primary outcome
RBANS score
Time frame: week 24
Repeatable Battery for the Assessment of Neuropsychological Status total score
RBANS score
Time frame: week 52
Repeatable Battery for the Assessment of Neuropsychological Status total score
4 secondary outcomes
PHQ-9
Time frame: week 24
PHQ-9
Time frame: week 52
GAD-7
Time frame: week 24
GAD-7
Time frame: week 52
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 12 Oct 2018.
- Derived from this study: PubMed 31518248Kumar 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.
- Derived from this study: PubMed 30104186Bott 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurotrack Virtual Cognitive Health Program in people with Subjective Cognitive Decline, run by Evidation Health 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 6 inclusion and 5 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 12 Oct 2018. 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?
RBANS score (time frame: week 24). The study lists 2 primary outcomes in all. 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 NCT02969460, which also lists 2 linked publications.
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 12 Oct 2018.