An interventional study of Home Telemonitoring System (The Zodiac, Philips Health care) in Cancer, sponsored by Philips Healthcare. Completed at 1 site in United Kingdom. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-18.
Sponsored by Philips Healthcare · Not applicable, Interventional, and Supportive care
The Zodiac, a Philips healthcare telemonitoring system has been devised to allow cancer patients receiving chemotherapy to test their blood count at home. It is anticipated that the system will allow patients and clinicians to reduce the toxic effects of chemotherapy by early diagnosis of neutropenia, anaemia and any associated complications of chemotherapy. It is also anticipated that the system will also allow clinicians to better manage the scheduling of chemotherapy regimes.
Philips Healthcare has devised a new home full blood count (FBC) home telemonitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home (haemoglobin, haematocrit, white cell count and neutrophil count). The system will also allow patients to record their temperature and symptoms. The Philips home telemonitoring system is called the Zodiac and consists of a telecommunications hub connected to a haematology analyser. The Hub connects to medical device software running on a remote server which controls the flow of information between the Hub and the clinician. This is designed to enable the patient to self test their full blood count in their home and transmit the data remotely to a clinician for review. In addition to testing their full blood count, the patients can input their temperature and any symptoms they have onto the device. The clinician will then be able to send appropriate instructions back to the patient. The Philips Zodiac system can also send a preprogrammed automated message based on the results of testing.
Exclusion Criteria:
All participants will receive a home telemonitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home.
Device: Home Telemonitoring System (The Zodiac, Philips Health care)
Full blood count (FBC) home tele-monitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home (haemoglobin, haematocrit, white cell count and neutrophil count).
Capillary Blood Sample
To achieve a read out result of a full blood count (haemoglobin, haematocrit, white cell count and neutrophil count) from capillary blood obtained by finger prick and analysed in the Philips Zodiac system that varies by no more than 15% from a sample reported by the standard hospital based laboratory analyser for white cell count, haemoglobin and haematocrit using venous blood.
Time frame: 3 times per week for 6 weeks
Number of variances in neutrophil and haemoglobin
To measure the number of variances in the neutrophil and haemoglobin values between the Philips Zodiac system and hospital laboratory analyser, which could result in a different clinical decision being made based on the management of patients at risk of neutropenia and anaemia.
Time frame: 3 times per week for 6 weeks
Usability
To document the level of satisfaction and feasibility using questionnaires, in the use of the Philips Zodiac system (training, ease of use, performing a blood test and preference for home testing versus hospital testing)
Time frame: 3 weeks and 6 weeks of use
Performance Evaluation
The questionnaire will assess the patients response to the flow of information via the server software, i.e. the ability of the Philips Zodiac system to provide the patient with a correct automated message or message from a clinician based on the results of the testing; the ability of patients to receive and understand the system messages; and, the satisfaction of patients with the Philips Zodiac System in terms of training issues, ease of use, performing a blood test, performing quality control tests and preference for home testing versus hospital testing.
Time frame: 3 times per week for weeks 1-6
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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