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Trial registered on ANZCTR


Registration number
ACTRN12615000813583
Ethics application status
Not yet submitted
Date submitted
22/06/2015
Date registered
6/08/2015
Date last updated
6/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Computer tablet based monitoring of vital signs of acute patients admitted to the Hospital in the Home Service at The Townsville Hospital
Scientific title
HITH Home Monitoring trial - Computer tablet based monitoring of vital signs of acute patients admitted to the Hospital in the Home Service at The Townsville hospital: evaluation of patient satisfaction
Secondary ID [1] 286948 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ambulatory patient population admitted to a Hospital in the Home Service 295391 0
Condition category
Condition code
Public Health 295982 295982 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be required to measure their own observations using a tablet based device four times per day for the length of their admission to the Hospital in the Home Service. The observations recorded will be pulse rate, temperature, blood pressure and blood oxygen saturations. These will be recorded using devices connected to the tablet device via a Bluetooth (TM) connection.These observations will be automatically uploaded to a secure internet based server where they will be viewed by the Clinical Nurse or Senior Medical Officer affiliated with the HITH Service.
Intervention code [1] 292147 0
Treatment: Devices
Comparator / control treatment
Usual care which involves observations being recorded by nursing staff during a home visit. This may be once per day up to three times per day.
Control group
Active

Outcomes
Primary outcome [1] 295364 0
Patient satisfaction measured using a locally devised HITH specific patient satisfaction survey tool incorporating the Net Promoter Score as developed by Reicheld (Reichheld, F. "One Number You Need to Grow". Harvard Business Review, December 2003)
Timepoint [1] 295364 0
From time of admission to service to time of discharge from service
Secondary outcome [1] 315432 0
Frequency of transfer back to The Townsville Hospital for in hospital care. This will be measured objectively and recorded in a spreadsheet located on a secured server with password access required.
Timepoint [1] 315432 0
From time of admission to service to time of discharge from service
Secondary outcome [2] 316114 0
Frequency of additional contact with nursing staff during admission outside of scheduled review. This will be measured objectively and recorded in a spreadsheet located on a secured server with password access required.
Timepoint [2] 316114 0
From time of admission to service to time of discharge from service

Eligibility
Key inclusion criteria
Acute ambulatory patients admitted to a Hospital in the Home Service which has the following inclusion criteria for all patients -
* Patient consents to the program
* Lives within 50km radius of TTH
* Adequate social support
* Refrigerator on site
* Safe environment (both for patient and visiting staff) assessed using a documented checklist
* Telephone available
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sepsis
Confusion/Delirium
Known IV drug user
Unable to obtain IV access
Pain not managed with oral analgesia
Inability to tolerate oral intake
Poorly managed co-morbidities
Immunocompromised

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients eligible for admission to the Hospital in the Home Service at The Townsville Hospital will be eligible for entry to this study. Patients will receive a written information sheet on the purpose of the study and it hypotheses. If they sign consent they will then be block randomised to receive either usual care - observations performed during nursing visits - or to take home a home monitoring device whereby they will then record their observations four times per day. This randomisation will occur using an internet based central randomisation tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Trial participants will be block randomised using Stratified Block Randomisation, we would achieve equal number of subjects stratified based on above 50 years and below 50years. Sample size calculations and Randomisation will be performed using the validated online resource, www.openepi.com.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size is based on the hypothesis that the satisfaction score will be higher in the Monitor group compared against the control (no monitor group).
If the true difference in the experimental and control means is 3 %, we will need to study 400 experimental subjects (monitor group) and 400 control subjects (no monitor group) to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.9. With the estimated standard deviations of 10 for each group, the Type I error probability associated with this test of this null hypothesis is 0.05.
The sample size has factored in a 15% drop out rate of patient discontinuing the study for various reasons that include, discontinuing use of machine, machine not functioning etc.
Data will be analysed using descriptive and comparative statistics by THHS epidemiologist and the statistician. Comparison of the number of nursing visits, hospital admissions and the satisfaction surveys will be conducted using either parametric t-tests or non-parametric Mann-Whitney U tests depending on whether the distributions are approximately normal or not. For comparing the differences between the groups ANOVA or Kruskal-wallis test will be used. Comparison of the proportions of readmissions will be performed using chi-square tests and 95%-confidence intervals. The statistical software SPSS version 21 (IBM SPSS Inc, Chicago, Illinois) will be used for analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2015
Actual
Date of last participant enrolment
Anticipated
29/08/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3951 0
The Townsville Hospital - Douglas

Funding & Sponsors
Funding source category [1] 291508 0
Hospital
Name [1] 291508 0
Townsville Hospital and Health Service Research Trust Fund Grant
Country [1] 291508 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Young
Address
Hospital in the Home Medical Officer
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country
Australia
Secondary sponsor category [1] 290189 0
Individual
Name [1] 290189 0
Dr Ben Close
Address [1] 290189 0
Director
Emergency Department
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country [1] 290189 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293048 0
HREC
Ethics committee address [1] 293048 0
Ethics committee country [1] 293048 0
Australia
Date submitted for ethics approval [1] 293048 0
30/06/2015
Approval date [1] 293048 0
Ethics approval number [1] 293048 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 505 505 0 0
/AnzctrAttachments/368795-Research Proposal Home Monitoring HITH THHS April 2015[1].doc

Contacts
Principal investigator
Name 58238 0
Dr Michael Young
Address 58238 0
Senior Medical Officer
Hospital in the Home Service
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 58238 0
Australia
Phone 58238 0
+61744331111
Fax 58238 0
Email 58238 0
michael.young2@health.qld.gov.au
Contact person for public queries
Name 58239 0
Michael Young
Address 58239 0
Senior Medical Officer
Hospital in the Home Service
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 58239 0
Australia
Phone 58239 0
+61744331111
Fax 58239 0
Email 58239 0
michael.young2@health.qld.gov.au
Contact person for scientific queries
Name 58240 0
Michael Young
Address 58240 0
Senior Medical Officer
Hospital in the Home Service
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 58240 0
Australia
Phone 58240 0
+61744331111
Fax 58240 0
Email 58240 0
michael.young2@health.qld.gov.au

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.