User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).

NCT ID: NCT06526637

Last Updated: 2024-08-05

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-05-31

Brief Summary

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The aim of this study is to evaluate the acceptability, safety and efficiency of the Palliate intervention.

The Palliate intervention is a nurse-led process that includes training and documentation materials to support lay carers in administering top up medications to loved ones at the end of life at home. The Palliate intervention was designed based on the CARiAD\* intervention using user testing and has been successfully piloted and rolled out in Central and North West London National Health Service (NHS) Foundation Trust.

\*CARer-ADministration of as-needed sub-cutaneous medication for breakthrough symptoms in homebased dying patients.

Detailed Description

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Conditions

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End of Life Support, Family

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will use direct observational methods in a workshop setting. Participants will be randomised to receive one of three Palliate training and material versions. Randomisation will be completed ahead of study commencement using a random number generator to allow the researcher time to prepare and set up the selected training information and materials. Randomisation will be conducted in blocks of three to ensure an even number randomised to each of the study arms (intervention version 1,2 and 3).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Version 1 of Palliate

Participants will be randomised to receive this version of Palliate training and materials.

Group Type ACTIVE_COMPARATOR

Paper Package

Intervention Type OTHER

Paper based (as per current practice at Central and North West London (CNWL) NHS Foundation Trust) version of Palliate.

Version 2 of Palliate

Participants will be randomised to receive this version of Palliate training and materials.

Group Type EXPERIMENTAL

V1 + Preparation Sheet

Intervention Type OTHER

Paper based version of Palliate plus a preparation sheet, that provides visual cues as to what equipment is required for the preparation and administration of the medications.

Version 3 of Palliate

Participants will be randomised to receive this version of Palliate training and materials.

Group Type EXPERIMENTAL

V2 + Video Training

Intervention Type OTHER

Hybrid - paper based materials, preparation sheet, and video instructions available via an interactive portable document format (PDF) version of the training materials.

Interventions

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Paper Package

Paper based (as per current practice at Central and North West London (CNWL) NHS Foundation Trust) version of Palliate.

Intervention Type OTHER

V1 + Preparation Sheet

Paper based version of Palliate plus a preparation sheet, that provides visual cues as to what equipment is required for the preparation and administration of the medications.

Intervention Type OTHER

V2 + Video Training

Hybrid - paper based materials, preparation sheet, and video instructions available via an interactive portable document format (PDF) version of the training materials.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 18 years or older and able to communicate in English.

Exclusion Criteria

* Individuals aged less than 18 years old and/or unable to communicate in English.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oak Foundation

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leila Shepherd, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Leila Shepherd, PhD

Role: CONTACT

+44 (0)20 7594 1419

David Sunkersing, PhD

Role: CONTACT

+44 (0)20 7594 1419

Other Identifiers

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OFIL-20-279

Identifier Type: -

Identifier Source: org_study_id

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