Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care (wePRO-CASA)

February 13, 2023 updated by: Thilo Schuler, Royal North Shore Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2067
        • Royal North Shore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Eligible patients will be identified by the Nurse Practitioner Cancer & Palliative Care.
Device: Garmin VivoSmart 4
Wearable sensor to record; sleep, stress, heart rate etc.
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.
Carers
The respective carers who are identified by the Nurse Practitioner Cancer & Palliative Care as eligible participants.
Device: Garmin VivoSmart 4
Wearable sensor to record; sleep, stress, heart rate etc.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 weeks
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 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal North Shore Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

August 5, 2021

Study Completion (Actual)

November 12, 2021

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • wePRO-CASA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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