Managing Vascular Dementia Risk Factors With SymTrend

Phase 1

• Conditions: Vascular Dementia

• Registration Number: NCT03702543
• Lead Sponsor: SymTrend Inc.

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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-08
• Last Update Submitted: 2018-10-08
• Study First Posted: 2018-10-11
• Last Update Posted: 2018-10-11
• Study Start: 2018-10-15
• Primary Completion: 2019-10-14
• Study Completion: 2019-10-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• Inability to use smartphone,
• Inability to read English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fatigue is reduced if originally is a problem	three months	Hours sleep increases and frequency of sleep interruption reduces

Trial Locations

Locations (1)

Neurology Department, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States