Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease (SenTra)

August 27, 2008 updated by: Tel-Aviv Sourasky Medical Center

The Use of Advanced Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease and Related Cognitive Disorders

The research is aimed at exploring the application of novel tracking technique for the study of spatial activity among dementia patients and its implication on their families. The study sample will be composed of three groups of volunteers, each including100 participants aged over 60 years. The first group will include MCI (Mild Cognitive Impairment) patients. The second group will include patients that suffer from mild dementia. The third group will include age matched healthy participants. The tracking equipment will be a GPS apparatus of 450 gms that will be carried by the participants for 24 hours along 2-4 weeks. The GPS data will be transferred via the cellular network to operator center at the Hebrew university at Jerusalem, and will be documented in assigned data files. This monitoring procedure will be held every year and along a period of five years. The impact of the patient behavior on the care giver will be studied by means of five interviews along the tracking period.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel-Aviv, Israel, 64239
        • Recruiting
        • Psychogeriatric clinic, Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Jeremia Heinik, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with MCI, Alzheimer's disease, or mixed type dementia; OR

  • Healthy control subjects who meet the following criteria:

    • Mini Mental State (MMSE) of at least 21
    • Age 60 years or older
    • Patients with history of stroke which is not followed by cognitive decline may be included
    • Fluent language skills

Exclusion Criteria:

  • Other dementias (e.g. vascular, frontotemporal, metabolic etc);
  • Other major psychiatric disorders (e.g. major depression, schizophrenia);
  • Substance abuse;
  • MMSE 20 or less;
  • Severe motor disturbances;
  • Sensory deficits potentially affecting mobility; OR
  • Severe physical disorders (e.g. cancer, major operation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Healthy controls Mini Mental State evaluation score >28/30
Device: GPS modem and RFID
The participant will take the GPS kit with him/her everywhere during the whole day for a period of 4 weeks. The GPS tracking kit consists of a GPS receiver with a GSM modem, an RF transmitter contained in a wrist-watch and a monitoring unit located in the home that enables researchers to know whenever the tracked person leaves home. The waterproof RF transmitter will allow researchers to know whether or not research subjects leave home with the GPS device and if they are carrying the device or not at a given moment.
Other: 2
Mild Cognitive Impairment: Mini Mental State Evaluation Score (MMSE)=26-28/30
Device: GPS modem and RFID
The participant will take the GPS kit with him/her everywhere during the whole day for a period of 4 weeks. The GPS tracking kit consists of a GPS receiver with a GSM modem, an RF transmitter contained in a wrist-watch and a monitoring unit located in the home that enables researchers to know whenever the tracked person leaves home. The waterproof RF transmitter will allow researchers to know whether or not research subjects leave home with the GPS device and if they are carrying the device or not at a given moment.
Other: 3
Mild Dementia: Mini Mental State Evaluation Score (MMSE)=21-25/30
Device: GPS modem and RFID
The participant will take the GPS kit with him/her everywhere during the whole day for a period of 4 weeks. The GPS tracking kit consists of a GPS receiver with a GSM modem, an RF transmitter contained in a wrist-watch and a monitoring unit located in the home that enables researchers to know whenever the tracked person leaves home. The waterproof RF transmitter will allow researchers to know whether or not research subjects leave home with the GPS device and if they are carrying the device or not at a given moment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation tools include: Geriatric Depression Scale, functional health questionnaire (SF-36), Emotional well-being questionnaire (Positive and Negative Affect Schedule; PANAS), single Life Satisfaction question and the Zarit Burden Interview
Time Frame: Before and after interventions
Before and after interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 28, 2008

Last Update Submitted That Met QC Criteria

August 27, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIP-K.3.1.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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