Managing Vascular Dementia Risk Factors With SymTrend
Primary Purpose
Vascular Dementia
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SymTrend, Inc.
Sponsored by
About this trial
This is an interventional prevention trial for Vascular Dementia
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
Sites / Locations
- Neurology Department, Massachusetts General Hospital
Outcomes
Primary Outcome Measures
Improved management of blood sugar
Blood sugars are measured regularly and are maintained within bounds prescribed by MD
Improved blood pressure management
Blood pressure is measured regularly and is within bounds prescribed by MD
Reduced smoking
Number of cigarettes smoked is reduced or eliminated
Weight is reduced if necessary
Food intake is reduced and is healthier, and as a consequence weight is reduced
Activity level is increased
Step count increases continuously throughout study period
Secondary Outcome Measures
Fatigue is reduced if originally is a problem
Hours sleep increases and frequency of sleep interruption reduces
Full Information
NCT ID
NCT03702543
First Posted
October 5, 2018
Last Updated
October 8, 2018
Sponsor
SymTrend Inc.
Collaborators
National Institute on Aging (NIA), Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03702543
Brief Title
Managing Vascular Dementia Risk Factors With SymTrend
Official Title
Managing Vascular Dementia Risk Factors With SymTrend
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Anticipated)
Primary Completion Date
October 14, 2019 (Anticipated)
Study Completion Date
October 14, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SymTrend Inc.
Collaborators
National Institute on Aging (NIA), Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
SymTrend, Inc.
Intervention Description
Use of SymTrend and Apple Health apps with feedback and strategies provided.
Primary Outcome Measure Information:
Title
Improved management of blood sugar
Description
Blood sugars are measured regularly and are maintained within bounds prescribed by MD
Time Frame
three months
Title
Improved blood pressure management
Description
Blood pressure is measured regularly and is within bounds prescribed by MD
Time Frame
three months
Title
Reduced smoking
Description
Number of cigarettes smoked is reduced or eliminated
Time Frame
three months
Title
Weight is reduced if necessary
Description
Food intake is reduced and is healthier, and as a consequence weight is reduced
Time Frame
three months
Title
Activity level is increased
Description
Step count increases continuously throughout study period
Time Frame
three months
Secondary Outcome Measure Information:
Title
Fatigue is reduced if originally is a problem
Description
Hours sleep increases and frequency of sleep interruption reduces
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minna Levine, Phd
Phone
16174917510
Email
symtrend@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minna Levine, Phd
Organizational Affiliation
SymTrend Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurology Department, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Managing Vascular Dementia Risk Factors With SymTrend
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