Wearable and Patient-reported Outcome-based Continuous As... | NCT05273580

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2021Actual

Primary Completion Date

Aug 5, 2021Actual

Completion Date

Nov 12, 2021Actual

First Submitted Date

Mar 1, 2022

First Submission Date that Met QC Criteria

Mar 1, 2022

First Posted Date

Mar 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2023

Last Update Posted Date

Feb 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thilo Schuler, Principal Investigator, Royal North Shore HospitalPrincipal Investigator

Lead Sponsor

Royal North Shore HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Eligible patients will be identified by the Nurse Practitioner Cancer & Palliative Care.	Device: Garmin VivoSmart 4 Device: mema - ilumivu
Carers		The respective carers who are identified by the Nurse Practitioner Cancer & Palliative Care as eligible participants.	Device: Garmin VivoSmart 4 Device: mema - ilumivu

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Garmin VivoSmart 4	Device	Wearable sensor to record; sleep, stress, heart rate etc.	Carers Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wearable compliance	Wearable compliance (compliance defined HR signal detected for >=70% of daytime hours between 7:30am to 7:30 pm)	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Quantitative and qualitative exploration of EMA/EMI acceptability	Exploration of EMA/EMI acceptability by patient/carer dyads quantitatively using experience surveys and qualitatively using an (optional) focus group.	2 hours
Correlative analysis of WS signals and ePRO's

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thilo Schuler	Royal North Shore Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal North Shore Hospital		St Leonards	New South Wales	2067	Australia

References Module

Citations

Not provided