Managing Vascular Dementia Risk Factors With SymTrend

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.

Study Overview

• Status: Unknown
• Conditions: Vascular Dementia
• Intervention / Treatment: Behavioral: SymTrend, Inc.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Neurology Department, Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to use smartphone,
• Inability to read English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved management of blood sugar	Blood sugars are measured regularly and are maintained within bounds prescribed by MD	three months
Improved blood pressure management	Blood pressure is measured regularly and is within bounds prescribed by MD	three months
Reduced smoking	Number of cigarettes smoked is reduced or eliminated	three months
Weight is reduced if necessary	Food intake is reduced and is healthier, and as a consequence weight is reduced	three months
Activity level is increased	Step count increases continuously throughout study period	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue is reduced if originally is a problem	Hours sleep increases and frequency of sleep interruption reduces	three months

Collaborators and Investigators

• Sponsor: SymTrend Inc.
• Collaborators: Massachusetts General Hospital; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Minna Levine, Phd, SymTrend Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2018
• Primary Completion (Anticipated): October 14, 2019
• Study Completion (Anticipated): October 14, 2019

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Dementia, Vascular
• Other Study ID Numbers: 1R43AG060851-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No