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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05273580




Registration number
NCT05273580
Ethics application status
Date submitted
1/03/2022
Date registered
10/03/2022
Date last updated
15/02/2023

Titles & IDs
Public title
Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care
Scientific title
Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Advanced Cancer Patients and Their Carers
Secondary ID [1] 0 0
wePRO-CASA
Universal Trial Number (UTN)
Trial acronym
wePRO-CASA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Care 0 0
Wearable Electronic Devices 0 0
Patient Reported Outcome Measures 0 0
Cancer 0 0
Caregiver 0 0
Digital Health 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Garmin VivoSmart 4
Treatment: Devices - mema - ilumivu

Patients - Eligible patients will be identified by the Nurse Practitioner Cancer & Palliative Care.

Carers - The respective carers who are identified by the Nurse Practitioner Cancer & Palliative Care as eligible participants.


Treatment: Devices: Garmin VivoSmart 4
Wearable sensor to record; sleep, stress, heart rate etc.

Treatment: Devices: mema - ilumivu
mEMA is the a self-service platform running on both iOS and Android that is specifically designed for the administration of mobile Ecological Momentary Assessment or Experience Sampling research studies.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Wearable compliance
Timepoint [1] 0 0
5 weeks
Secondary outcome [1] 0 0
Quantitative and qualitative exploration of EMA/EMI acceptability
Timepoint [1] 0 0
2 hours
Secondary outcome [2] 0 0
Correlative analysis of WS signals and ePRO's
Timepoint [2] 0 0
5 weeks

Eligibility
Key inclusion criteria
- Palliative care patient attending at Northern Sydney Cancer Centre, RNSH

- Patient and carer dyad

- Both patient and carer consent

- Patient Karnofsky Performance Scale = 50

- Patient and carer have compatible smart phone
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Unwilling or unable to give informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2021
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2067 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Non-professional carers (typically family members) play a critical role in providing adequate
home care. This research explores the use of wearable sensors (WS) and electronic
patient-reported outcome (ePRO) surveys to monitor stress levels of advanced cancer
patient/carer dyads. During wear times, WS-triggered ecological momentary assessments (EMAs)
were conducted via short smartphone-based surveys. This pilot study investigates the
feasibility of EMAs in community palliative care.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05273580
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thilo Schuler
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries