Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000018617p
Ethics application status
Submitted, not yet approved
Date submitted
14/11/2022
Date registered
10/01/2023
Date last updated
10/01/2023
Date data sharing statement initially provided
10/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the acceptability of remotely monitoring the vital signs of hospital-in-the-home patients using wearable devices, from the perspective of the patients, clinicians and administrators.
Scientific title
Investigating the impact of remote patient monitoring of vital signs on communication and the experience of hospital-in-the-home patients, clinicians, and administrators
Secondary ID [1] 308271 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deterioration among hospital-in-the-home patients 328050 0
Condition category
Condition code
Public Health 325107 325107 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Biobeat Wrist Monitor or Biobeat Chest Monitor will be issued to participants (n=10 for each group) and will constantly monitor respiratory rate, oxygen saturation, heart rate and blood pressure during the trial. Standard care will not be altered. If a device indicates medical attention is required, additional care will be given.
Both devices have been approved by the Australian Government Department of Health Therapeutic Goods Administration (TGA) as a Class IIa medical device (certificate number: DV-2020-MC-18871-1; ARTG identifier: 338811; date of approval: 02/07/2020). Both Device A and Device B are classified as non-invasive for the use of vital sign monitoring in adults, in clinical and non-clinical settings.
Both devices are capable of monitoring and measuring an array of patient vital signs, though for the purposes of this project only respiratory rate, oxygen saturation (SPO2), heart rate, and blood pressure will be assessed. The effective range and accuracy of both devices are the same.

Watches and adhesive patches are required to be worn 24 hours a day for 6 days.

The watch is to be worn on the preferred wrist and will be calibrated by the clinician issuing the device and remote monitoring team. The watch will be collected from the client post the study. The adhesive patch will be applied to the chest and be calibrated by the issuing clinician and remote monitoring team. Patches are single use and will be discarded by the client after use.
A potentially unstable client is a client that has appeared on the exceeding vitals tile within the monitoring dashboard, having passed the threshold for one of the following vitals: heart rate, SPO2, systolic blood pressure or temperature. An alert within the web dashboard will be triggered every time a vital is measured above or below the set threshold. The thresholds are customised for each client that is admitted to the study. The clinical monitoring process will monitor alerts 24/7. If an abnormal vital sign is detected a nurse will triage the observations based on the Silverchain escalation protocol (e.g. level 1 increase monitoring, level 2 medical governance review, level 3 emergency response). Medical governance will make a treatment / intervention plan as clinically required.

The nurse visiting the clients home as part of standard care (post consent) will set up the device with the client with the support of the remote monitoring team.

The web dashboard communicates for each client if there are any instances where the device has been turned off, taken off or if the signal is poor. To mitigate this we verify the placement of the device is according to the instructions. We also make sure the devices are properly used (e.g., excluding sports activity, extreme physical effort). The system has a threshold for the signal’s quality, and data below that threshold level will not be recorded (will be defined as invalid data) in the system’s database.

Participants will be allocated to one of three conditions (wrist monitor, chest monitor, or standard care) using computer-generated random numbers. However, in the event that a participant presents with a physiological risk factor precluding use one of the monitors (e.g., a skin condition that precludes the use of adhesives), that participant will be allocated to another condition, using computer-generated random numbers where multiple other conditions are suitable.
Intervention code [1] 324727 0
Early detection / Screening
Comparator / control treatment
A control group (n=10) will just receive standard care.

Standard care for the purposes of this study is the standard number of visits scheduled for each individual patient. This differs depending on the needs of each client. At each visit, the clinician will perform manual observations of vital signs based on each clients condition (e.g heart rate, SPO2, systolic blood pressure or temperature).
Control group
Active

Outcomes
Primary outcome [1] 332929 0
Understanding patient treatment experience. Using a questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT)
Timepoint [1] 332929 0
Beginning February 2023, client participants will have device set up and collection of vital sign data will commence and run for 6 days.

Client questionnaire given to control group and client intervention group (post receiving standard care and following the 6 day device trial for each intervention group participant)
Secondary outcome [1] 415186 0
Acceptability and feasibility of the wearables will be determined from a Clinical perspective (e.g. doctors, nurses, etc.). Approximately 4-6 clinicians will participate in a virtual focus group, facilitated by a member of the research team.
Timepoint [1] 415186 0
Starting approximately April 2023, following the 6 day trial for clients,
Secondary outcome [2] 416915 0
Acceptability and feasibility of the wearables from an Administrative Manager perspective

This will be determined via a virtual focus group with approximately 2 Administrative Managers, facilitated by a member of the research team.
Timepoint [2] 416915 0
Starting approximately April 2023, following the 6 day trial for clients.
Secondary outcome [3] 416916 0
Acceptability and feasibility of the wearables from an Administrative Manager perspective

This will be determined via a virtual focus group with approximately 3 IT Managers, facilitated by a member of the research team.
Timepoint [3] 416916 0
Starting approximately April 2023, following the 6 day trial for clients.

Eligibility
Key inclusion criteria
i. Aged between 40 – 60 years, and
ii. Enrolled in (or about to be enrolled in) Silver Chain's 'hospital in the home' (HITH)/'hospital at the home' (HATH) programs, and
iii. Possess a sufficient English proficiency to understand the Participant Information and Consent Form (PICF) without requiring a translator.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Do not speak English/requires a translator.
ii. Possess a significant cognitive impairment or psychological illness (e.g. dementia) that would inhibit participation (as determined by a Silver Chain clinician).
iii. Are receiving palliative care.
iv. Are considered to be a 'high severity' patient:
a. Is immunocompromised
b. Is unable to manage pain with simple analgesics
c. Currently has/previously had diabetic foot ulcers
d. Currently identified as obese
e. Currently prescribed multiple courses of intravenous antibiotics.
v. Are considered to be a 'high bleeding risk' patient:
a. Recent (within the last 4 weeks) major bleed
b. Recent (within the last 2 weeks) major surgery
c. Thrombocytopaenia (platelet count < 50 x 109L)
d. Known liver disease
e. Concurrent antiplatelet therapy
f. Risk of septic shock (fever > 38.5°C; Systolic BP < 90mmHg; HR > 100/min).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to one of three conditions (wrist monitor, chest monitor, or standard care) using computer-generated random numbers. However, in the event that a participant presents with a physiological risk factor precluding use one of the monitors (e.g., a skin condition that precludes the use of adhesives), that participant will be allocated to another condition, using computer-generated random numbers where multiple other conditions are suitable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
T-tests will be used to determine differences between patients in the study arms in their perceptions of the care received.
Interview and focus group data will be analysed thematically. The framework approach, which focuses on deductive and inductive content analysis, will be used to analyse the transcribed data. The sequential plan is as follows:
i. Deductive content analysis: An unconstrained categorisation matrix will be developed based on existing theory/pre-existing theoretical constructs from previous carer research. Transcribed data will then be coded according to this matrix. Coding of the transcribed data will also include the frequency of each construct within the matrix, that is, how many times each construct was raised/agreed with during discussion. Ten-percent of codes will be re-reviewed by a second reviewer and consensus reached between points of difference between both reviewers to ensure rigour in analysis. Note: healthcare professional interview data will be analysed, however without the expectation that data saturation will be reached, as the sample size is pragmatic.
ii. Inductive content analysis: The categorisation matrix will then be broadened to accommodate any new constructs identified in the transcribed data.
iii. Deductive content analysis: A deductive approach can then be used to help further explain these new constructs entered into the categorisation matrix, and how they might influence existing theory in this area.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312521 0
Commercial sector/Industry
Name [1] 312521 0
Silver Chain Group Limited
Country [1] 312521 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Silver Chain Group Limited
Address
6 Sundercombe Street, Osborne Park, WA, 6017
Country
Australia
Secondary sponsor category [1] 314121 0
None
Name [1] 314121 0
Address [1] 314121 0
Country [1] 314121 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311854 0
Monash Health
Ethics committee address [1] 311854 0
Ethics committee country [1] 311854 0
Australia
Date submitted for ethics approval [1] 311854 0
27/04/2022
Approval date [1] 311854 0
Ethics approval number [1] 311854 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122610 0
Ms Kate Symons
Address 122610 0
Silverchain,
Galleria Building,
Suite 4, Level 27,
385 Bourke Street,
Melbourne,
VICTORIA 3000
Country 122610 0
Australia
Phone 122610 0
+61 0412915375
Fax 122610 0
Email 122610 0
[email protected]
Contact person for public queries
Name 122611 0
Kate Symons
Address 122611 0
Silverchain,
Galleria Building,
Suite 4, Level 27,
385 Bourke Street,
Melbourne,
VICTORIA 3000
Country 122611 0
Australia
Phone 122611 0
+61 412915375
Fax 122611 0
Email 122611 0
[email protected]
Contact person for scientific queries
Name 122612 0
Nilmini Wickramasinghe
Address 122612 0
Swinburne University of Technology,
John St, Hawthorn,
VIC 3122
Country 122612 0
Australia
Phone 122612 0
+61 1300 794 628
Fax 122612 0
Email 122612 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.