Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care

NCT05273580 | Completed DMC

• 1 other identifier: wePRO-CASA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care; Wearable Electronic Devices; Patient Reported Outcome Measures; Cancer; Caregiver; Digital Health

Outcome Measures

Primary Outcomes (1)

• Wearable compliance

  Wearable compliance (compliance defined HR signal detected for \>=70% of daytime hours between 7:30am to 7:30 pm)

  5 weeks

Secondary Outcomes (2)

• Quantitative and qualitative exploration of EMA/EMI acceptability

  2 hours

• Correlative analysis of WS signals and ePRO's

  5 weeks

Study Arms (2)

Patients

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

Device: Garmin VivoSmart 4; Device: mema - ilumivu

Carers

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

Device: Garmin VivoSmart 4; Device: mema - ilumivu

Interventions

Garmin VivoSmart 4 DEVICE

Wearable sensor to record; sleep, stress, heart rate etc.

Carers; Patients

mema - ilumivu DEVICE

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.

Carers; Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Palliative care patient and their respective carer attending at Northern Sydney Cancer Centre, RNSH.

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to give informed consent

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2067, Australia

Location

Related Links

• Project website

MeSH Terms

Conditions

Neoplasms

Study Officials

• Thilo Schuler

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: April 15, 2021
• Primary Completion: August 5, 2021
• Study Completion: November 12, 2021
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

AU (1)