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Completed

NCT Number: NCT05273580

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal North Shore Hospital

St Leonards, New South Wales, 2067, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Unwilling or unable to give informed consent

Treatment and study plan

Garmin VivoSmart 4

Device

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

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Quantitative and qualitative exploration of EMA/EMI acceptability

    Time frame: 2 hours

    Exploration of EMA/EMI acceptability by patient/carer dyads quantitatively using experience surveys and qualitatively using an (optional) focus group.

  2. Correlative analysis of WS signals and ePRO's

    Time frame: 5 weeks

    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

Sponsors and collaborators

Lead sponsor

Royal North Shore Hospital

Other

Registry information

Official study title

Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Advanced Cancer Patients and Their Carers

Acronym: wePRO-CASA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2022
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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