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

NCT06526637 | Completed

• 1 other identifier: OFIL-20-279
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End of Life; Support, Family

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Participant scores of acceptability of the intervention as per the responses on the Theoretical Framework of Acceptability (TFA) questionnaire. Free text or verbal responses noted when completing the questionnaire will be thematically analysed as informed by the TFA. The TFA questionnaire is an eight-item questionnaire. Raw total scores range from 8 (the worst possible score) to 40 (the best possible score).

  Through study completion per participant (≤ 5 weeks)

Secondary Outcomes (6)

• Usability

  Through study completion per participant (≤ 5 weeks)

• Incidence of error

  Through study completion per participant (≤ 5 weeks)

• Efficiency

  Through study completion per participant (≤ 5 weeks)

• Factors contributing to error, potential errors and acceptability of the intervention

  Through study completion per participant (≤ 5 weeks)

• Learnability/ Retained learning

  Through study completion per participant (≤ 5 weeks)

Study Arms (3)

Version 1 of Palliate

ACTIVE COMPARATOR

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

Other: Paper Package

Version 2 of Palliate

EXPERIMENTAL

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

Other: V1 + Preparation Sheet

Version 3 of Palliate

EXPERIMENTAL

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

Other: V2 + Video Training

Interventions

Paper Package OTHER

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

Version 1 of Palliate

V1 + Preparation Sheet 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 2 of Palliate

V2 + Video Training OTHER

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

Version 3 of Palliate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Individuals aged less than 18 years old and/or unable to communicate in English.

Sponsors & Collaborators

• Imperial College London: lead
• Oak Foundation: collaborator

Study Sites (1)

Imperial College London

London, United Kingdom

Location

MeSH Terms

Conditions

Death

Interventions

myotrophin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leila Shepherd, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: September 26, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)