Managing Vascular Dementia Risk Factors With SymTrend

NCT03702543 | Unknown Phase 1 DMC

• 1 other identifier: 1R43AG060851-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Dementia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Fatigue is reduced if originally is a problem

  three months

Interventions

SymTrend, Inc. BEHAVIORAL

Use of SymTrend and Apple Health apps with feedback and strategies provided.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to use smartphone,
• Inability to read English

Sponsors & Collaborators

• SymTrend Inc.: lead
• National Institute on Aging (NIA): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Neurology Department, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Minna Levine, Phd

  SymTrend Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minna Levine, Phd

CONTACT

16174917510; symtrend@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 11, 2018
• Study Start: October 15, 2018
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)