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

Primary Purpose

Dementia

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
GPS modem and RFID
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Psychogeriatric clinic, Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

1

2

3

Arm Description

Healthy controls Mini Mental State evaluation score >28/30

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

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2008
Last Updated
August 27, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00743418
Brief Title
Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease
Acronym
SenTra
Official Title
The Use of Advanced Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease and Related Cognitive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Healthy controls Mini Mental State evaluation score >28/30
Arm Title
2
Arm Type
Other
Arm Description
Mild Cognitive Impairment: Mini Mental State Evaluation Score (MMSE)=26-28/30
Arm Title
3
Arm Type
Other
Arm Description
Mild Dementia: Mini Mental State Evaluation Score (MMSE)=21-25/30
Intervention Type
Device
Intervention Name(s)
GPS modem and RFID
Intervention Description
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremia Heinik, MD
Phone
972-3-6974817
Email
jeremiah@tasmc.health.gov.il
Facility Information:
Facility Name
Psychogeriatric clinic, Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremia Heinik, MD
Phone
972-3-6974817
Email
jeremiah@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Jeremia Heinik, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
18366748
Citation
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.
Results Reference
background
Links:
URL
http://geography.huji.ac.il/sentra/index.html
Description
SenTra Website

Learn more about this trial

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

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