Managing Vascular Dementia Risk Factors With SymTrend

Study Overview
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Brief Summary
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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
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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.

Official Title
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Managing Vascular Dementia Risk Factors With SymTrend

Conditions
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Vascular Dementia

Intervention / Treatment
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* Behavioral: SymTrend, Inc.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior incidence of neurological event such as transient ischemic attack, stroke. Exclusion Criteria: Inability to use smartphone, Inability to read English

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: SymTrend, Inc.|Use of SymTrend and Apple Health apps with feedback and strategies provided.|

What is the study measuring?
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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 |