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

NCT ID: NCT05273580

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2021-11-12

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

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

Garmin VivoSmart 4

Intervention Type DEVICE

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

mema - ilumivu

Intervention Type 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

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

Garmin VivoSmart 4

Intervention Type DEVICE

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

mema - ilumivu

Intervention Type 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.

Interventions

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Garmin VivoSmart 4

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

Intervention Type DEVICE

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 Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal North Shore Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thilo Schuler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thilo Schuler

Role: PRINCIPAL_INVESTIGATOR

Royal North Shore Hospital

Locations

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Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status

Countries

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Australia

Related Links

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Other Identifiers

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wePRO-CASA

Identifier Type: -

Identifier Source: org_study_id

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