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Primary Palliative Care - a Feasibility Cluster Trial

NCT07737899 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-03

No results posted yet for this study

Summary

This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness. One FHU will receive the intervention and one FHU will follow usual care. The primary goal is to assess feasibility metrics (GP adherence, patient recruitment rate, and patient retention rate), which will inform the design of a subsequent full-scale cluster RCT.

Conditions

  • Palliative Care
  • Primary Palliative Care
  • Advanced Cancer
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Congestive Heart Failure Chronic
  • Chronic Kidney Disease (Stages 4 and 5)

Interventions

OTHER

Primary Palliative Care Complex Intervention (PrimPal)

1. GPs will receive an e-learning palliative care training programme with a 30-h load, including topics such as the role of communication, the main problems and symptoms of patients with palliative care needs and how to assess and control them. Additionally, the programme covered how to apply the newly developed medical consultation model and how to use the Integrated Palliative Care Outcome Scale (IPOS) patient version 2. Primary palliative care consultation model divided into five areas (1) summarizing clinical information, (2) objective symptoms' management, (3) assessment and coding of chronic diseases and symptoms, (4) planning clinical approach and (5) addressing other problems/concerns - 4 consultations over 12 weeks.

Sponsors & Collaborators

  • Unidade Local de Saúde de Coimbra, EPE

    collaborator OTHER

  • University of Coimbra

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-02-28
Completion
2027-08-31

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07737899 on ClinicalTrials.gov