Managing Vascular Dementia Risk Factors With SymTrend

• Sponsor: SymTrend Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03702543
• Collaborator: National Institute on Aging (NIA) (NIH), Massachusetts General Hospital (Other)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 0.8

Study Details

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.

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

• Study Type: Interventional
• Anticipated 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.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
• Anticipated Study Start Date: Oct 15, 2018
• Anticipated Primary Completion Date: Oct 14, 2019
• Anticipated Study Completion Date: Oct 14, 2019

Outcome Measures

Primary Outcome Measures

1. Improved management of blood sugar [three months]

   Blood sugars are measured regularly and are maintained within bounds prescribed by MD

2. Improved blood pressure management [three months]

   Blood pressure is measured regularly and is within bounds prescribed by MD

3. Reduced smoking [three months]

   Number of cigarettes smoked is reduced or eliminated

4. Weight is reduced if necessary [three months]

   Food intake is reduced and is healthier, and as a consequence weight is reduced

5. Activity level is increased [three months]

   Step count increases continuously throughout study period

Secondary Outcome Measures

1. Fatigue is reduced if originally is a problem [three months]

   Hours sleep increases and frequency of sleep interruption reduces

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Neurology Department, Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Minna Levine, Phd, SymTrend Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SymTrend Inc.
• ClinicalTrials.gov Identifier: NCT03702543
• Other Study ID Numbers: 1R43AG060851-01; 1R43AG060851-01
• First Posted: Oct 11, 2018
• Last Update Posted: Oct 11, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Dementia, Vascular

Study Results

No Results Posted as of Oct 11, 2018