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Completed

NCT Number: NCT02196428

Medical Telemonitoring Plus Individual Teleconsultation in Elderly

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).

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Key information

Conditions

Telemedicine

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Telemedicine, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemonitoring and Teleconsultation

Other

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.

Primary outcomes

  1. 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:

    • 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).

  2. 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

  3. Acceptance medical telemonitoring and teleconsultation

    Time frame: 10 months

    • 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

Secondary outcomes

  1. Acceptance and demand of health information of secondary end users of telemedical services

    Time frame: 10 months

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2014
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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