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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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