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

Sponsor
Royal North Shore Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05273580
Collaborator
(none)
30
Enrollment
1
Location
6.9
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research explores the use of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys as tools to describe activity patterns and stress levels of advanced cancer patient/caregiver dyads in order to understand their needs better.

Physiological data will be recorded passively during wearable sensors wear times. Electronic patient-reported outcome surveys will be used to perform ecological momentary assessments (EMAs) triggered by WS signals. If this pilot finds ecological momentary assessments useful, feasible and scalable, a long-term aim for follow-on studies is to translate EMA-based interventions into routine care.

Condition or Disease Intervention/Treatment Phase
  • Device: Garmin VivoSmart 4
  • Device: mema - ilumivu

Detailed Description

Non-professional carers (typically family members) play a critical 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. There is an interrelationship between patients' depressive symptoms and carers' anxiety and likely other forms of distress. This research explores the use of wearable sensors and electronic patient-reported outcome surveys as tools to describe activity patterns and stress levels of advanced cancer patient/caregiver dyads in order to understand their needs better.

Physiological data will be recorded passively during WS wear times. Electronic patient-reported outcome surveys will be used to perform ecological momentary assessments triggered by wearable sensors signals. If this pilot finds ecological momentary assessments useful, feasible and scalable, a long-term aim for follow-on studies is to translate EMA-based interventions into routine care. This may comprise conventional support strategies informed by needs discovered through ecological momentary assessments during the pilot project, or if deemed feasible, ecological momentary interventions (EMIs) that use EMAs beyond the pilot to trigger just-in-time targeted interventions

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Advanced Cancer Patients and Their Carers
Actual Study Start Date :
Apr 15, 2021
Actual Primary Completion Date :
Aug 5, 2021
Actual Study Completion Date :
Nov 12, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Wearable compliance [5 weeks]

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

Secondary Outcome Measures

  1. Correlative analysis of WS signals and ePRO's [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

  2. Qualitative exploration of EMAs/EMIs in focus group [2 hours]

    Qualitative exploration of EMAs/EMIs in focus group regarding: Acceptability by patient/carer dyads Scalability into routine care Perception of potential clinical utility by clinicians

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal North Shore Hospital St Leonards New South Wales Australia 2067

Sponsors and Collaborators

  • Royal North Shore Hospital

Investigators

  • Principal Investigator: Thilo Schuler, Royal North Shore Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thilo Schuler, Principal Investigator, Royal North Shore Hospital
ClinicalTrials.gov Identifier:
NCT05273580
Other Study ID Numbers:
  • wePRO-CASA
First Posted:
Mar 10, 2022
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 17, 2022