Clinical trial NCT03702543: Managing Vascular Dementia Risk Factors With SymTrend
Official title: Managing Vascular Dementia Risk Factors With SymTrend
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Vascular Dementia
Lead sponsor: SymTrend Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: Massachusetts General Hospital
First posted: 2018-10-11
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Inability to use smartphone,
* Inability to read English

Primary outcomes:
measure: Improved management of blood sugar
timeFrame: three months
measure: Improved blood pressure management
timeFrame: three months
measure: Reduced smoking
timeFrame: three months
measure: Weight is reduced if necessary
timeFrame: three months
measure: Activity level is increased
timeFrame: three months
Secondary outcomes:
measure: Fatigue is reduced if originally is a problem
timeFrame: three months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Neurology Department, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: SymTrend Inc.
name: Minna Levine, Phd
role: PRINCIPAL_INVESTIGATOR
References: