Remote Assessment of Signs and Symptoms in Palliative Care | NCT06587321

Studies
Remote Assessment of Signs and Symptoms in Palliative Care

NCT06587321

Sponsor

Our Lady's Hospice and Care Services

Status

Recruiting

Last Update Posted

Jun 27, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Palliative Care
Vital Signs
Remote Monitoring

Interventions

Not provided

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

Mar 31, 2025Actual

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Sep 5, 2024

First Submission Date that Met QC Criteria

Sep 5, 2024

First Posted Date

Sep 19, 2024Actual

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

Jun 23, 2025

Last Update Posted Date

Jun 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Andrew Davies, Professor of Palliative Medicine, Our Lady's Hospice and Care ServicesPrincipal Investigator

Lead Sponsor

Our Lady's Hospice and Care ServicesOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Digital health interventions, including remote monitoring of patients, have been identified as a possible way to address current problems within the health service, including insufficient numbers of staff, and an increasing number of patients requiring services.

The aim of this study is to assess the feasibility of using remote monitoring for patients who are receiving palliative care and to see whether remote monitoring can improve care and outcomes for patients and their families.

Participants in this study will complete regular (daily, weekly, monthly) questionnaires online about how they are feeling. They will also be given equipment to measure their vital signs every day. The clinical team will have access to the results and be able to respond to any new problems as they arise. Patients and their carers will then complete a questionnaire at one month to assess satisfaction with the use of remote monitoring.

Detailed Description

Not provided

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Completion rates of assessments	Number of assessments completed over the study time-frame	At the end of 1 month

Secondary Outcomes

Measure	Description	Time Frame
Recruitment rate	The number of patients approached to take part in the study who then entered the study	6 months
Retention rate	The number of patients who entered and then completed the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary diagnosis of advanced cancer or another life-limiting condition
Estimated prognosis greater than 3 months
Referred for community-based specialist palliative care
Living in own home (or home of family carer)
Living with a family carer

Exclusion Criteria:

Estimated prognosis less than 3 months or more than 12 months
Cognitive impairment - unable to provide consent / complete assessments
Non-English speaker
Living in care home / nursing home / hospice / community hospital
Not living with a family carer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who have a diagnosis of a life-limiting condition, who are receiving care from the community palliative care team

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gemma O'Keeffe	Contact	01 406 8700	6235	gokeeffe@olh.ie

Overall Officials

Name	Affiliation	Role
Jenny Power	Our Lady's Hospice & Care Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Our Lady's Hospice & Care Services	Recruiting	Dublin	Dublin	D6W RY72	Ireland