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

NCT00743418 | Unknown Phase 1

• 1 other identifier: DIP-K.3.1.
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (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

  Before and after interventions

Study Arms (3)

1

OTHER

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

Device: GPS modem and RFID

2

OTHER

Mild Cognitive Impairment: Mini Mental State Evaluation Score (MMSE)=26-28/30

Device: GPS modem and RFID

3

OTHER

Mild Dementia: Mini Mental State Evaluation Score (MMSE)=21-25/30

Device: GPS modem and RFID

Interventions

GPS modem and RFID 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.

1; 2; 3

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Psychogeriatric clinic, Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 18366748 BACKGROUND

MeSH Terms

Conditions

Dementia

Interventions

Radio Frequency Identification Device

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Patient Identification Systems; Organization and Administration; Health Services Administration

Central Study Contacts

Jeremia Heinik, MD

CONTACT

972-3-6974817; jeremiah@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2012
• Last Updated: August 28, 2008

Record last verified: 2008-08

Locations

IL (1)