Palliative CarewePRO-CASANCT05273580
Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care
An observational study of Palliative Care and Wearable Electronic Devices, run by Royal North Shore Hospital at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Wearable Electronic Devices, Patient Reported Outcome Measures
- What is being tested?
- Garmin VivoSmart 4 and mema - ilumivu
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Apr 2021to 12 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Palliative care patient and their respective carer attending at Northern Sydney Cancer Centre, RNSH.
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal North Shore Hospital
St Leonards, New South Wales, 2067
About this study
Official title: Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Advanced Cancer Patients and Their Carers
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.
Read the detailed description
Non-professional carers (typically family members) play a critical role in providing adequate home care along with professional caregivers. However, the physical and emotional toll of caring for a family member can lead to distress and burn out of the carer. The latter often results in the need for temporary or permanent institutional care of the patient. This research explores the feasibility of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor activity patterns and stress levels of advanced cancer patient/caregiver dyads in order to understand their needs better.
Throughout the study, wearable sensors are used to passively record physiological data from patient/carer dyads. During wear times, WS recordings trigger ecological momentary assessments (EMAs) conducted via surveys. This pilot investigates the feasibility and acceptability of EMAs in community palliative care and the potential for incorporating EMA-based interventions into routine care. Future studies may explore the possibility of ecological momentary interventions (EMIs) to trigger just-in-time targeted interventions.
- Conditions
- Palliative Care, Wearable Electronic Devices, Patient Reported Outcome Measures, Cancer, Caregiver, Digital Health
- Being tested
- Garmin VivoSmart 4, mema - ilumivu
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garmin VivoSmart 4Device
Wearable sensor to record; sleep, stress, heart rate etc.
mema - ilumivuDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Eligible patients will be identified by the Nurse Practitioner Cancer \& Palliative Care. Receives: Device: Garmin VivoSmart 4; Device: mema - ilumivu | |
| Carers | The respective carers who are identified by the Nurse Practitioner Cancer \& Palliative Care as eligible participants. Receives: Device: Garmin VivoSmart 4; Device: mema - ilumivu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearable compliance
Wearable compliance (compliance defined HR signal detected for >=70% of daytime hours between 7:30am to 7:30 pm)
Measured: 5 weeks
Secondary outcomes (2)
Quantitative and qualitative exploration of EMA/EMI acceptability
Exploration of EMA/EMI acceptability by patient/carer dyads quantitatively using experience surveys and qualitatively using an (optional) focus group.
Measured: 2 hours
Correlative analysis of WS signals and ePRO's
Correlative analysis of WS signals and ePRO answers with focus on:
- Intra-dyadic longitudinal trends (Is there correlation between metrics of a patient and their carer?)
- EMA trigger incidences and distribution of ePRO-stated trigger reasons including "false alarms" of the whole cohort
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start15 Apr 2021
- Primary completion5 Aug 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thilo Schuler, Royal North Shore Hospital
- Investigators
- Thilo Schuler, Principal investigator, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273580
- Sponsor's protocol ID
- wePRO-CASA
- Acronym
- wePRO-CASA
- Status last verified
- Feb 2023
- First submitted
- 1 Mar 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of this trial will be published in a peer reviewed journal. We are targeting high-impact palliative care journals such as 'Palliative Medicine' for publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Advanced Cancer Patients and Their Carers
- ClinicalTrials.gov ID
- NCT05273580
- Acronym / sponsor ID
- wePRO-CASA / wePRO-CASA
- Conditions
- Palliative Care, Wearable Electronic Devices, Patient Reported Outcome Measures, Cancer, Caregiver, Digital Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-professional carers (typically family members) play a critical role in providing adequate home care along with professional caregivers. However, the physical and emotional toll of caring for a family member can lead to distress and burn out of the carer. The latter often results in the need for temporary or permanent institutional care of the patient. This research explores the feasibility of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor activity patterns and stress levels of advanced cancer patient/caregiver dyads in order to understand their needs better.
Throughout the study, wearable sensors are used to passively record physiological data from patient/carer dyads. During wear times, WS recordings trigger ecological momentary assessments (EMAs) conducted via surveys. This pilot investigates the feasibility and acceptability of EMAs in community palliative care and the potential for incorporating EMA-based interventions into routine care. Future studies may explore the possibility of ecological momentary interventions (EMIs) to trigger just-in-time targeted interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Garmin VivoSmart 4, Device: mema - ilumivuEligible patients will be identified by the Nurse Practitioner Cancer \& Palliative Care. |
| Carers | – | Device: Garmin VivoSmart 4, Device: mema - ilumivuThe respective carers who are identified by the Nurse Practitioner Cancer \& Palliative Care as eligible participants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Palliative care patient and their respective carer attending at Northern Sydney Cancer Centre, RNSH.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling or unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garmin VivoSmart 4Wearable sensor to record; sleep, stress, heart rate etc. | Device | Carers, Patients |
| mema - ilumivumEMA 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. | Device | Carers, Patients |
Primary outcome
Wearable compliance
Time frame: 5 weeks
Wearable compliance (compliance defined HR signal detected for >=70% of daytime hours between 7:30am to 7:30 pm)
2 secondary outcomes
Quantitative and qualitative exploration of EMA/EMI acceptability
Time frame: 2 hours
Correlative analysis of WS signals and ePRO's
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The results of this trial will be published in a peer reviewed journal. We are targeting high-impact palliative care journals such as 'Palliative Medicine' for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thilo Schuler principal investigator
Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Wearable Electronic Devices, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wearable compliance (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.