Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

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DRKS-ID: DRKS00009740

Trial Description

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Title

Wearable health technologies for older, chronically ill patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

In an aging society an increasing number of people is no longer able to cope with their disease due to multimorbidity and cognitive impairments. These physical and psychological impairments often result in a loss of quality of life. In 2009 in Germany, 60% of women and 53% of men older than 65 years were facing at least on chronic disease. In total, there are more than 80% of people older than 65 years in western European Countries who suffer from a chronic condition. Many of them are in need of help on a daily basis to deal with their disease.
One variant of wearable health technologies (WHT) to support health promotion behavior are so called fitness trackers, which are body worn sensors. With their aid, patient data can be documented and analyzed to provide feedback about their current health status. Reliable data about psycho-social factors influencing the usage of WHT and subjective experiences of patients are largely missing. This prospective study consists of a qualitative information collection on patients’ perspectives and expectations with respect to WHT in advanced age. The observations gained through this first part of the project will be used to define the design of an intervention step to address efficacy and tolerability of a wearable tool in the aged as far as well-being and disease-relevant basic vital parameters are concerned.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00009740
Date of Registration in DRKS: 2016/02/12
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 15-350, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln

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Secondary IDs

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Health Condition or Problem studied

ICD10: I00-I99 - Diseases of the circulatory system
ICD10: E11 - Non-insulin-dependent diabetes mellitus

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Interventions/Observational Groups

Arm 1: People with Diabetes Type II and cardiovascular disease, their relatives and treating physicians are queried once with the aid of a semi-structured questionnaire concerning their perspectives and expectations with respect to wearable health technologies. Additionally they are questioned about sociodemographic data.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Other
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

Qualitative survey of the study participants concerning their perspectives and expectations with respect to wearable health technologies.

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Secondary Outcome

none

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center Klinik II für Innere Medizin, Köln
University Medical Center Herzzentrum, Köln

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2015/11/23
Target Sample Size: 12
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 65 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

People older than 65 years with Diabetes Type II and cardiovascular disease are questioned. They should live independently at home. At the moment of the interview they should not be hospitalized. Their relatives and treating physician are also queried. Participation must be voluntarily. Study participants must be fluent in German language.

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Exclusion Criteria

At least one includion criteria is not the case.

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Addresses

Primary Sponsor
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- Fortschrittskolleg Wohlbefinden bis ins hohe Alter
- Ms. Prof. Dr. Susanne Zank
- Albertus-Magnus-Platz
- 50923 Köln
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://hf.uni-koeln.de/37221
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Contact for Scientific Queries
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- Forschungsstelle Ethik
- Ms. Prof. Dr. med. Christiane Woopen
- Universitätsstr. 91
- 50931 Köln
- Germany
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- Telephone: 0221 470-89100
- Fax: [---]*
- E-mail: forschungsstelle-ethik at uni-koeln.de
- URL: http://geschichte-ethik.uk-koeln.de/de/forschungsstelle-ethik/aktuelles
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Contact for Public Queries
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- Forschungsstelle Ethik
- Ms. Prof. Dr. med. Christiane Woopen
- Universitätsstr. 91
- 50931 Köln
- Germany
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- Telephone: 0221 470-89100
- Fax: [---]*
- E-mail: forschungsstelle-ethik at uni-koeln.de
- URL: http://geschichte-ethik.uk-koeln.de/de/forschungsstelle-ethik/aktuelles
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Ministerium für Innovation, Wissenschaft und Forschung des Landes Nordrhein-Westfalen
- Völklinger Straße 49
- 40221 Düsseldorf
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2016/04/30

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Trial Publications, Results and other Documents

Paper: Wearables zur Unterstützung des Selbstmanagements von älteren Menschen mit chronischen Erkrankungen

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