Transcript HES Feasibility study protocol (Module for respiratory

Monitoring COPD and asthma:
technological developments in the
IMCA II Project
Enric Duran
Institut Municipal d’Assistència Mèdica al Personal Municipal (PAMEM)
Municipal Institut of Medical Research (IMIM)
Subgroup on Health Examination Surveys
Luxembourg, 20 January 2010
IMCA II
Working Packages overview
• WP 1: Coordination of the project.
• WP 2: Dissemination of the results.
• WP 3: Evaluation of the project.
• WP 4: Indicators from routine database.
• WP 5: Indicators from international research studies.
• WP 6: HES Feasibility Study – Respiratory diseases
Respiratory Health Survey in the Elderly
HES Feasibility Study
Objectives
• To assess the feasibility of using Motohealth system as
a tool for performing interviews and measurements at
home in the context of large scale respiratory surveys at
national and international level.
• To evaluate to what extent the Motohealth system can
improve response rates to questionnaires, the
acceptability of measurements performance and
biological samples collection when the measurements
are performed at home in comparison to other settings
such as a primary health care centre.
Methodology
Study design: randomized controlled trial
(Model A)
Model B
Random sample
N=250
From small GA
Group A
N=125
Group B
N=125
Fieldwork at home
Fieldwork at the PCC
Methodology
Study design and population
• Which model will perform each country?
– 1st Wave: Spain (Model A) and Sweden, Germany, Italy
(Pisa) and Italy (Rome) (Model B).
– 2nd Wave: France (Model A) Poland, Greece, Norway
and Bulgaria decided (Model B).
– In summary 10 centres will perform the HES Feasibility
Study.
– Other countries despite funding difficulties can explore
ways of making it possible (national funding or helping
them to obtain funding).
Methodology
Technology and communication system
(MOTOHEALTH)
• MOTOHEALTH is a tool which integrates
questionnaire design, field work management,
measurements performance, data collection
and transmission on line with high eficiency and
quality reducing costs and time for data
analysis.
Methodology
Technology and communication system
(MOTOHEALTH)
• Is an integrated mobile monitoring system.
• Allows remote monitoring of chronic patients or
healthy individuals.
• Transmits the data through wireless communication
(GPRS) in a secure mode to a central repository server.
• Professionals review the data and take decisions
accordingly to patient/individual situation.
Methodology
Technology and communication system
(MOTOHEALTH)
The system integrates three main applications:
• Backend Application (BEA):
this is the application for study
administration, importing individuals to the system and the administration
of professionals involved in the study.
• Survey Application (SVA): this is the application administered by the
field worker for the measurements performance and questionnaires
completion at individuals home.
• Geographic Location Application (GLA): this is the application that
facilitates the work of the phone operators for the the individuals
scheduling visits according to a geographical area.
Methodology
Technology and communication system
Wireless sensors, handset/computer, call center, central server
Key professionals involved and roles
SM
Study Manager
Phone operator
Field worker
Study manager
Overview of the fieldwork materials and tools?
PC portàtil
SM
Methodology
Measurements performed and sensors
characteristics
• Spirometry (NDD Easy One Model 2001).
• Blood pressure monitor UA -767BT (A&D Medical).
• Pulse-oximetry (NONIN 4000 Avant Bluetooth).
• Weight (A&D - Medical UC-321PL).
• Height (Laser).
• Blood sample: Hemograme, Cholesterol, C-Reactive
Proteine and Creatinine.
Methodology
Questionnaires selected (Adults & Children)
• Adults questionnaire: GA2LEN screening
quetionnaire.
– 21 questions.
– Translated to four languages or more.
• Children’s questionnaire: ISAAC II protocol
(selected questions):
– 32 questions.
– Translated to four languages or more.
Methodology
Consent Form
• Which are the options for all individuals?
– A) The questionnaire and all described measurements.
– B) The questionnaire and all marked measurements:
– Weight and height
– Spirometry (Pre and Post-bronchodilator)
– Pulse-oximetry
– Blood pressure
– Blood extraction
– C) Only the questionnaire.
– Blood extraction
What we expect from the
technology used in this study?
MOTOHEALTH
System
Web IMCA: www.imca.cat