Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Managing Vascular Dementia Risk Factors With SymTrend

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702543
Recruitment Status : Unknown
Verified October 2018 by SymTrend Inc..
Recruitment status was:  Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Massachusetts General Hospital
Information provided by (Responsible Party):
SymTrend Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Vascular Dementia Behavioral: SymTrend, Inc. Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Managing Vascular Dementia Risk Factors With SymTrend
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 14, 2019
Estimated Study Completion Date : October 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Improved management of blood sugar [ Time Frame: three months ]
    Blood sugars are measured regularly and are maintained within bounds prescribed by MD

  2. Improved blood pressure management [ Time Frame: three months ]
    Blood pressure is measured regularly and is within bounds prescribed by MD

  3. Reduced smoking [ Time Frame: three months ]
    Number of cigarettes smoked is reduced or eliminated

  4. Weight is reduced if necessary [ Time Frame: three months ]
    Food intake is reduced and is healthier, and as a consequence weight is reduced

  5. Activity level is increased [ Time Frame: three months ]
    Step count increases continuously throughout study period


Secondary Outcome Measures :
  1. Fatigue is reduced if originally is a problem [ Time Frame: three months ]
    Hours sleep increases and frequency of sleep interruption reduces


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to use smartphone,
  • Inability to read English
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702543


Contacts
Layout table for location contacts
Contact: Minna Levine, Phd 16174917510 symtrend@gmail.com

Locations
Layout table for location information
United States, Massachusetts
Neurology Department, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
SymTrend Inc.
National Institute on Aging (NIA)
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Minna Levine, Phd SymTrend Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: SymTrend Inc.
ClinicalTrials.gov Identifier: NCT03702543    
Other Study ID Numbers: 1R43AG060851-01 ( U.S. NIH Grant/Contract )
1R43AG060851-01 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
 Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases