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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00743418
First received: August 27, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dementia
 Device: GPS modem and RFID
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Use of Advanced Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease and Related Cognitive Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2007
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743418

Contacts
Contact: Jeremia Heinik, MD 972-3-6974817 jeremiah@tasmc.health.gov.il

Locations
Israel
Psychogeriatric clinic, Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: Jeremia Heinik, MD     972-3-6974817     jeremiah@tasmc.health.gov.il    
Principal Investigator: Jeremia Heinik, MD            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Additional Information:
SenTra Website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr' Jeremia Heinik, Psychogeriatric clinic, Sourasky Medical Center, Tel-Aviv Israel
ClinicalTrials.gov Identifier: NCT00743418     History of Changes
Other Study ID Numbers: DIP-K.3.1.
Study First Received: August 27, 2008
Last Updated: August 27, 2008
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013