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

Dementia Clinical Trial

— SenTra  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00743418
• Other study ID #: DIP-K.3.1.
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 27, 2008
• Last updated: August 27, 2008
• Start date: June 2007

Study information

• Verified date: August 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Jeremia Heinik, MD
• Phone: 972-3-6974817
• Email: jeremiah[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.

Locations

Country	Name	City	State
Israel	Psychogeriatric clinic, Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   SenTra Website