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

Completed
Conditions
Patient Reported Outcome Measures
Palliative Care
Digital Health
Wearable Electronic Devices
Cancer
Caregiver
Interventions
Device: Garmin VivoSmart 4
Device: mema - ilumivu
Registration Number
NCT05273580
Lead Sponsor
Royal North Shore Hospital
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
CarersGarmin VivoSmart 4The respective carers who are identified by the Nurse Practitioner Cancer \& Palliative Care as eligible participants.
PatientsGarmin VivoSmart 4Eligible patients will be identified by the Nurse Practitioner Cancer \& Palliative Care.
Patientsmema - ilumivuEligible patients will be identified by the Nurse Practitioner Cancer \& Palliative Care.
Carersmema - ilumivuThe respective carers who are identified by the Nurse Practitioner Cancer \& Palliative Care as eligible participants.
Primary Outcome Measures
NameTimeMethod
Wearable compliance5 weeks

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

Secondary Outcome Measures
NameTimeMethod
Correlative analysis of WS signals and ePRO's5 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

Quantitative and qualitative exploration of EMA/EMI acceptability2 hours

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

Trial Locations

Locations (1)

Royal North Shore Hospital

🇦🇺

St Leonards, New South Wales, Australia

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