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

NCT ID: NCT00743418

Last Updated: 2008-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Healthy controls Mini Mental State evaluation score \>28/30

Group Type OTHER

GPS modem and RFID

Intervention Type DEVICE

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

Group Type OTHER

GPS modem and RFID

Intervention Type DEVICE

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

Group Type OTHER

GPS modem and RFID

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Psychogeriatric clinic, Sourasky Medical Center, Tel-Aviv Israel

Locations

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Psychogeriatric clinic, Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Jeremia Heinik, MD

Role: CONTACT

Phone: 972-3-6974817

Email: [email protected]

Facility Contacts

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Jeremia Heinik, MD

Role: primary

References

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Shoval N, Auslander GK, Freytag T, Landau R, Oswald F, Seidl U, Wahl HW, Werner S, Heinik J. The use of advanced tracking technologies for the analysis of mobility in Alzheimer's disease and related cognitive diseases. BMC Geriatr. 2008 Mar 26;8:7. doi: 10.1186/1471-2318-8-7.

Reference Type BACKGROUND
PMID: 18366748 (View on PubMed)

Other Identifiers

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DIP-K.3.1.

Identifier Type: -

Identifier Source: org_study_id