Managing Vascular Dementia Risk Factors With SymTrend

Vascular Dementia Clinical Trial

Official title:

Managing Vascular Dementia Risk Factors With SymTrend

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03702543
• Other study ID #: 1R43AG060851-01
• Secondary ID: 1R43AG060851-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 15, 2018
• Est. completion date: October 14, 2019

Study information

• Verified date: October 2018
• Source: SymTrend Inc.
• Contact: Minna Levine, Phd
• Phone: 16174917510
• Email: symtrend[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to use smartphone,

• Inability to read English

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Behavioral:
• SymTrend, Inc.
Use of SymTrend and Apple Health apps with feedback and strategies provided.

Locations

Country	Name	City	State
United States	Neurology Department, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
SymTrend Inc.	Massachusetts General Hospital, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved management of blood sugar	Blood sugars are measured regularly and are maintained within bounds prescribed by MD	three months
Primary	Improved blood pressure management	Blood pressure is measured regularly and is within bounds prescribed by MD	three months
Primary	Reduced smoking	Number of cigarettes smoked is reduced or eliminated	three months
Primary	Weight is reduced if necessary	Food intake is reduced and is healthier, and as a consequence weight is reduced	three months
Primary	Activity level is increased	Step count increases continuously throughout study period	three months
Secondary	Fatigue is reduced if originally is a problem	Hours sleep increases and frequency of sleep interruption reduces	three months