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

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ClinicalTrials.gov Identifier: NCT00743418
Recruitment Status : Unknown
Verified August 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : August 28, 2008
Last Update Posted : August 28, 2008
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Dementia Device: GPS modem and RFID Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2007
Estimated Primary Completion Date : December 2012


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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): 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

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.
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: August 28, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders