- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03038841
Mobile Health Technology for Palliative Care Patients
June 20, 2017 updated by: University of Zurich
Mobile Health Technologies for Palliative Care Patients at the Interface of In-patient to Out-patient Care: A Feasibility Study Aiming to Early Predict Deterioration of Patient's Health Status
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zurich
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Zürich, Zurich, Switzerland, 8091
- Recruiting
- Clinic of Radiation-Oncology University Hospital Zurich
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Contact:
- Gudrun Theile, MD
- Phone Number: +41 44 255 5495
- Email: gudrun.theile@usz.ch
-
Contact:
- Matea Pavic, MD
- Phone Number: +41 44 255 3015
- Email: matea.pavic@usz.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 105 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized at one of the wards of the Clinic of Radiation-Oncology University Hospital Zurich, including a ward of specialized Palliative Care
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility (time of complete data transfer in weeks)
Time Frame: 12 weeks
|
time of complete data transfer in weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Matthias Guckenberger, Prof, Clinic of Radiation-Oncology USZ
- Study Chair: Gerhard Tröster, Prof, ETH Zurich
- Principal Investigator: Gudrun Theile, MD, Clinic of Radiation-Oncology USZ
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Anticipated)
May 31, 2018
Study Completion (Anticipated)
May 31, 2018
Study Registration Dates
First Submitted
January 25, 2017
First Submitted That Met QC Criteria
January 31, 2017
First Posted (Estimate)
February 1, 2017
Study Record Updates
Last Update Posted (Actual)
June 21, 2017
Last Update Submitted That Met QC Criteria
June 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PC 16/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.