- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02196428
Medical Telemonitoring Plus Individual Teleconsultation in Elderly
Medical Telemonitoring Plus Individual Teleconsultation Based on an Ambient Assisted Living (AAL-) Wizard - an Interdisciplinary, Integrated Innovation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The technical development of the so-called "AAL Wizard" is basis for the study. The AAL-Wizard is an IHE(Integrating the Healthcare Enterprise)-compliant, web based documentation and communication platform with an integrated electronic patient record, which can be used by the study participants during the study. Vital parameters are collected with the help of certified medical products according to the guidelines "93/42/EEC(European Economic Community) on medical devices" (e.g. blood pressure devices, scales, pedometers), transmitted electronically, documented and archived directly in the system. Vital parameters out of range will be prioritized displayed in the AAL Wizard (e.g. traffic light system, short message notification, pop-up function, etc.) and the study participant will be contacted by the tele doctor (teleconsultation) . The decision on the necessary intervention (e.g. contact of the in-house home care, therapeutic and diagnostic recommendations or recommendation of a primary care consultation /hospital submission) are in the responsibility of the tele doctor based on the communication with the patient and the family doctor's recommendations for the treatment of his patient.
At the beginning of the study, the tele doctors of the Clinical Telemedicine at the University Hospital Zurich (USZ) perform an appointment with the respective study participants. The electronic patient record will be set up and the process of the telemonitoring will be defined.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland, 8091
- Clinical Telemedicine, University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- german speaking
- voluntary participation
- written consent of the trial participant after enlightenment
Exclusion criteria:
- apply to health conditions (physical and / or psychological) when verbal communication and / or the operation of the AAL Wizard and an independent living in their own living area is not possible.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Telemonitoring and Teleconsultation
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The interventions of this study are supported by a so-called Ambient Assisted Living Wizard (AAL Wizard).
This is an IHE-compliant documentation and communication platform with an integrated electronic health record, which enables the study participants (elderly) to manage and store their relevant health data.
It includes personal master data and the documentation of telemonitoring data.
Additionally, the AAL-Wizard provides the communication modules such as telephone -, video- and time- and online consultation.
The tele doctor assess the data (eg, vital signs and content of the medical teleconsultation) and collaborates in this way with the older person, family physicians and other health care providers based on an innovative and flexible telemedical home care service.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
User profile of medical telemonitoring and teleconsultation
Time Frame: 10 months
|
Objective criteria: Age, sex, weight, height, education, civil status, diagnosis, medical history, medication, alcohol and tabacco consumption using interval, nominal and ordinal scales. Subjective criteria:
|
10 months
|
Demand of health information
Time Frame: 10 months
|
Text analysis with inductive category developement of teleconsultation services via telephone, video and online consultation and telemonitoring
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10 months
|
Acceptance medical telemonitoring and teleconsultation
Time Frame: 10 months
|
|
10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptance and demand of health information of secondary end users of telemedical services
Time Frame: 10 months
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Acceptance and demand of health information of telemedical service of secondary end users (family practitioner, other caregivers, family) using text analysis with inductive category developement and open structured, inductive questionnaires.
|
10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christiane Brockes, MD, PD, University Hospital Zurich, Rämistrasse 100, 8091 Zurich, Switzerland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USZ 14809.2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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