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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03038841
Other study ID # PC 16/16
Secondary ID
Status Recruiting
Phase N/A
First received January 25, 2017
Last updated June 20, 2017
Start date February 1, 2017
Est. completion date May 31, 2018

Study information

Verified date January 2017
Source University of Zurich
Contact Gudrun Theile, MD
Phone +41 44 255 5495
Email gudrun.theile@usz.ch
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To test the potential and acceptance of wireless activity tracking in palliative care patients leaving hospital care. Explorative study, collaboration project of the Clinic of Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in order to gather objective physical activity parameters as step count, sleep duration, heart rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between patients' physical activity patterns and the pain and distress level assessed from electronic scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by quantitative questionnaires and interviews. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on fostering early interventions for symptom relief and support of QoL.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 105 Years
Eligibility Inclusion Criteria:

- established diagnosis of metastatic cancer or other severe illness with limited life-expectancy (physicians guess <12 months, > 8 weeks)

- Karnofsky Index =50%

- ECOG= 2

- aged > 18 years

- passed a short handling test with devices (tracking bracelet, smart phone)

Exclusion Criteria:

- relevant cognitive impairment

- insufficient knowledge of German language.

Study Design


Intervention

Device:
Mobile Health
Patients discharged from hospital will be equipped with a tracking bracelet and a smart phone

Locations

Country Name City State
Switzerland Clinic of Radiation-Oncology University Hospital Zurich Zürich Zurich

Sponsors (3)

Lead Sponsor Collaborator
University of Zurich Swiss Academy of Medical Sciences (SAMS), Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility (time of complete data transfer in weeks) time of complete data transfer in weeks 12 weeks
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