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Managing Vascular Dementia Risk Factors With SymTrend

NCT ID: NCT03702543

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-10-14

Brief Summary

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Individuals with uncontrolled vascular disease are at risk for an insidious progression of brain injury starting in early to midlife and ultimately culminating in a vascular dementia, robbing them of activities of daily living independence. Successful containment of this progression requires rigorous vascular risk factor management - the control of blood pressure, blood sugars, weight, and alcohol consumption; the cessation of smoking, and an increase in aerobic activity. SymTrend's mobile and web system for managing vascular risk factors will help improve adherence to health and lifestyle strategies, will stem cognitive decline, and will preserve independence in the community for older adults.

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Detailed Description

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Neurologists from Massachusetts General Hospital will refer 10 adults with vascular mild cognitive impairment for participation in this project. The patients will be given Bluetooth devices appropriate for their condition and will be trained to use SymTrend and Apple Health software. They will use the software and devices for three months; will receive messages throughout from the system and/or a research coordinator about their progress, with encouragement and strategies to fully manage their symptoms; and their neurologist will be in communication with them about the progress charts and will adjust their care on the basis of this real-time data.

Conditions

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Vascular Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

In this feasibility study, a customized electronic diary will be provided to collect data 1) from bluetooth devices, 2) from Apple Health app information, and 3) from self-reported diary information. Researchers will provide feedback via charts and reminders/text messages to encourage management of vascular risk factors.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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SymTrend, Inc.

Use of SymTrend and Apple Health apps with feedback and strategies provided.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Prior incidence of neurological event such as transient ischemic attack, stroke.

Exclusion Criteria

* Inability to use smartphone,
* Inability to read English
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

SymTrend Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minna Levine, Phd

Role: PRINCIPAL_INVESTIGATOR

SymTrend Inc.

Locations

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Neurology Department, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Minna Levine, Phd

Role: CONTACT

[email protected]
16174917510

Other Identifiers

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1R43AG060851-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R43AG060851-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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