Medical Telemonitoring Plus Individual Teleconsultation in Elderly

Telemedicine Clinical Trial

Official title:

Medical Telemonitoring Plus Individual Teleconsultation Based on an Ambient Assisted Living (AAL-) Wizard - an Interdisciplinary, Integrated Innovation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196428
• Other study ID #: USZ 14809.2
• Status: Completed
• Phase: N/A
• First received: July 17, 2014
• Last updated: December 3, 2015
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to explore the requirements and conditions of medical teleconsultation and remote diagnostics (telemonitoring) of older people in the residential environment with an emphasis on the need for adaptation, feasibility and acceptance of telemedicine services to a web based documentation and communication platform (Ambient Assisted Living Wizard).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Telemedicine

Intervention

Other:
• Telemonitoring and Teleconsultation
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.

Locations

Country	Name	City	State
Switzerland	Clinical Telemedicine, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User profile of medical telemonitoring and teleconsultation	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: Subjective state of health : German questionnaire Short Form (SF)-36/SF-12; Integration into social networks and assessment of social support, self-management skills: 10-item questionnaire using 5-point Likert scale responses do not apply at all (1) to apply (5).; Health literacy: 13-item questionnaire using 4-point Likert scale responses do not apply (1) to apply (4).	10 months	No
Primary	Demand of health information	Text analysis with inductive category developement of teleconsultation services via telephone, video and online consultation and telemonitoring	10 months	No
Primary	Acceptance medical telemonitoring and teleconsultation	Observed acceptance in relation to the intervention; compliance using inducive category development; quality of service : 3-item questionnaire using 5-point Likert scale responses do not apply at all (1) to apply (5); Acceptance of user using inducive category development	10 months	No
Secondary	Acceptance and demand of health information of secondary end users of telemedical services	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	No