Trial document
This trial has been registered retrospectively.
DRKS00009740
Trial Description
Title
Wearable health technologies for older, chronically ill patients
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.
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
- DRKS00009740
- 2016/02/12
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- yes
- Approved
- 15-350, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
Secondary IDs
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Health Condition or Problem studied
- I00-I99 - Diseases of the circulatory system
- E11 - Non-insulin-dependent diabetes mellitus
Interventions/Observational Groups
- 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.
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Other
- Single (group)
- N/A
- N/A
Primary Outcome
Qualitative survey of the study participants concerning their perspectives and expectations with respect to wearable health technologies.
Secondary Outcome
none
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- University Medical Center
Recruitment
- Actual
- 2015/11/23
- 12
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 65 Years
- no maximum age
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.
Exclusion Criteria
At least one includion criteria is not the case.
Addresses
-
start of 1:1-Block address primary-sponsor
- Fortschrittskolleg Wohlbefinden bis ins hohe Alter
- Ms. Prof. Dr. Susanne Zank
- Albertus-Magnus-Platz
- 50923 Köln
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
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- http://hf.uni-koeln.de/37221
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Forschungsstelle Ethik
- Ms. Prof. Dr. med. Christiane Woopen
- Universitätsstr. 91
- 50931 Köln
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0221 470-89100
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- forschungsstelle-ethik at uni-koeln.de
- http://geschichte-ethik.uk-koeln.de/de/forschungsstelle-ethik/aktuelles
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Forschungsstelle Ethik
- Ms. Prof. Dr. med. Christiane Woopen
- Universitätsstr. 91
- 50931 Köln
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0221 470-89100
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- forschungsstelle-ethik at uni-koeln.de
- http://geschichte-ethik.uk-koeln.de/de/forschungsstelle-ethik/aktuelles
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Ministerium für Innovation, Wissenschaft und Forschung des Landes Nordrhein-Westfalen
- Völklinger Straße 49
- 40221 Düsseldorf
- Germany
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end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2016/04/30