Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000780651
Ethics application status
Approved
Date submitted
3/07/2014
Date registered
21/07/2014
Date last updated
21/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to look at the feasibility of using remote vital sign monitoring app to improve the care of patients being treated at home with highly myelosuppressive chemotherapy.
Scientific title
Pilot study to look at the feasibility of using remote vital sign monitoring app to improve the care of patients being treated at home with highly myelosuppressive chemotherapy.
Secondary ID [1] 284995 0
Nil
Universal Trial Number (UTN)
U1111-1158-8210
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelosuppression 292390 0
Cancer 292500 0
Condition category
Condition code
Cancer 292708 292708 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to assess the vital sign monitoring app designed by SecuraHeath (Registered Trademark) to see if it can improve the care of patients receiving very myelosuppressive chemotherapy regimens.

To do this we will compare the continuous vital sign monitor with the normal four times a day oral thermometer measurement (both measurements taken from the same patient).

The patient wears a patch (which they place on the chest wall) which relays a signal to the smart phone app continuously. The smart phone app relays the message to a central database. The central database is configured with limits which alarm when the data is out of a defined range. The central database can be viewed by the health service.

The app is used to monitor the temperature during the period of neutropenia post chemotherapy (usually days 8-14 of the chemotherapy cycle).
Intervention code [1] 289742 0
Treatment: Devices
Comparator / control treatment
Oral thermometer measurements taken by the patient and recorded on a data sheet.
Control group
Active

Outcomes
Primary outcome [1] 292549 0
To assess the feasibility of using an intelligent, mobile, remote, vital sign monitoring device (Securafone (Registered Trademark) Health) to monitor patients receiving highly myelosuppressive chemotherapy regimens at home with Chemo@home.
Feasibility is assessed through a simple patient questionnaire.
Timepoint [1] 292549 0
12 months
Primary outcome [2] 292550 0
To assess the validity of the data by calculating the correlation between the values measured by the continuous device and the conventional measurement.
Timepoint [2] 292550 0
12 months
Secondary outcome [1] 309205 0
Nil
Timepoint [1] 309205 0
Nil

Eligibility
Key inclusion criteria
Patients being treated with highly myelosuppressive chemotherapy (e.g. regimens for high grade lymphoma or leukaemia).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years of age.
Patients with pacemakers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients having treatment for highly myelosuppressive chemotherapy identified by specialists and referred for the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Feasibility will be tested in the first ten patients and a decision will be made on whether to continue the study for another 10 patients. Use of the device will deemed feasible if eight of ten patients can withstand the sensor during the day, there are no unresolved practical issues related to the patch (e.g. adhesive quality) and the monitor reflects the true body temperature. Patients will be interviewed to assess the acceptability of wearing the sensor device on the body during the day. The validity of the continuous measurements will be assessed by comparing pairs of simultaneously measured values (Securafone and oral thermometer) and calculating the correlation and regression between them. If in the first ten patients there are no problems identified that prohibit extension of the study, another ten patients will be enrolled (i.e 20 patients in total).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be collected by the patients, their carer or the Chemo@home nurses on a data collection form developed specifically for the project. Variables include: Height, weight, gender, age, core body temperature (measured orally), ambient temperature, layers of clothing, full blood counts (when available), disease, chemotherapy regimen and perceived stress.
All temperature measurements will be recorded during the observation period. Data will be entered into SPSS(Registered Trademark) for analysis. Correlation and regression analysis will be performed to assess the validity of the Securafone measurements relative to corresponding measurements from the oral thermometer (the gold standard in this study). The effects of age, BMI, gender and any other variable that may affect differences in temperature reading between Securafone and oral thermometer will be determined by linear regression methods. We will also calculate the: (i) positive predictive value (PPV, the probability that Securafone identifies a true febrile episode (temperature greater than or equal 38 degrees c by oral thermometer) in patients recorded as febrile by the Securafone; and (ii) sensitivity (the probability that Securafone identifies a febrile episode in patients with true febrile episodes as identified by oral thermometer). Sensitivity also provides a measure of the false negative proportion (1 – Sensitivity). The sensitivity provides an indication of whether the Securafone is accurate enough to use in measuring temperature, whilst the PPV is the measure that will be useful to clinicians once it has been determined that the sensitivity is sufficiently high enough to use the test in clinical practice.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
Date of last participant enrolment
Anticipated
30/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8414 0
6005 - West Perth

Funding & Sponsors
Funding source category [1] 289545 0
Charities/Societies/Foundations
Name [1] 289545 0
Leukaemia Foundation
Country [1] 289545 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
View Health Pty Ltd
Address
241 Fitzgerald St, West Perth WA 6005
Country
Australia
Secondary sponsor category [1] 288230 0
None
Name [1] 288230 0
Address [1] 288230 0
Country [1] 288230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291285 0
St John Of God Healthcare
Ethics committee address [1] 291285 0
12 Salvado Rd, Subiaco 6008 WA
Ethics committee country [1] 291285 0
Australia
Date submitted for ethics approval [1] 291285 0
11/06/2014
Approval date [1] 291285 0
17/06/2014
Ethics approval number [1] 291285 0
EC 689

Summary
Brief summary
This is a study to determine whether using a remote vital sign monitoring application improves the care in patients being treated with highly myelosuppressive chemotherapy at home.
Who is it for?
You may be eligible to join this study if you aged 18 years or above and are being treated with highly myelosuppressive chemotherapy.

Study details
Participants in this study will be using the remote vital sign application device at home for during the time when their white cell count is low (usually day 8-14 of the chemotherapy cycle). The remote vital sign application will be attached to the skin by a patch adhesive and it will monitor vital signs such as body temperature and heart rate. During this time, oral thermometer measurements will also be taken manually and recorded on a data sheet. Information from the device and the manual oral measurements will be collated after the white cell count has recovered, and the patch is removed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49686 0
Miss Sharni Wilkes
Address 49686 0
View Health
241 Fitzgerald St, West Perth WA 6005
Country 49686 0
Australia
Phone 49686 0
+61 8 9328 3123
Fax 49686 0
Email 49686 0
[email protected]
Contact person for public queries
Name 49687 0
Ms Julie Wilkes
Address 49687 0
View Health
241 Fitzgerald St, West Perth WA 6005
Country 49687 0
Australia
Phone 49687 0
+61 8 9328 3123
Fax 49687 0
Email 49687 0
[email protected]
Contact person for scientific queries
Name 49688 0
Ms Julie Wilkes
Address 49688 0
View Health
241 Fitzgerald St, West Perth 6005
Country 49688 0
Australia
Phone 49688 0
+61 8 9328 3123
Fax 49688 0
Email 49688 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.