NCT02196428

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

July 17, 2014

Last Update Submit

December 3, 2015

Conditions

Keywords

Ambient Assisted Living (AAL)TelemonitoringTeleconsultation

Outcome Measures

Primary Outcomes (3)

  • 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: 1. Subjective state of health : German questionnaire Short Form (SF)-36/SF-12 2. 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). 3. Health literacy: 13-item questionnaire using 4-point Likert scale responses do not apply (1) to apply (4).

    10 months

  • Demand of health information

    Text analysis with inductive category developement of teleconsultation services via telephone, video and online consultation and telemonitoring

    10 months

  • Acceptance medical telemonitoring and teleconsultation

    1. 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) 2. Acceptance of user using inducive category development

    10 months

Secondary Outcomes (1)

  • Acceptance and demand of health information of secondary end users of telemedical services

    10 months

Study Arms (1)

Telemonitoring and Teleconsultation

OTHER
Other: Telemonitoring and Teleconsultation

Interventions

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.

Telemonitoring and Teleconsultation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • german speaking
  • voluntary participation
  • written consent of the trial participant after enlightenment

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Telemedicine, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Remote Consultation

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Christiane Brockes, MD, PD

    University Hospital Zurich, Rämistrasse 100, 8091 Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 22, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations