Primary Palliative Care - a Feasibility Cluster Trial | NCT07737899

NCT07737899

Overview

NCT ID: NCT07737899
Lead Sponsor: University of CoimbraOTHER
Official Title: Primary Palliative Care - a Feasibility Cluster Trial
Brief 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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Feb 28, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Aged 18 years or older.

Enrolled as a patient on the list of a recruited General Practitioner in one of the participating Family Health Units.

Diagnosed with one or more of the following advanced chronic conditions:

Advanced-stage neoplasm (metastatic/stage IV cancer);

Chronic Obstructive Pulmonary Disease (COPD) - GOLD classification III or IV;

Congestive Heart Failure (CHF) - New York Heart Association (NYHA) functional classification III or IV;

Chronic Kidney Disease (CKD) - stage IV or V.

Exclusion Criteria:

Refusal to provide informed consent or to participate in the study at any point.

Disease severity requiring urgent medical intervention (acute crisis/emergency care need at time of recruitment).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Carlos S Cardoso, PhDContact
carlosseicacardoso@uc.pt00351 239 857 700

Similar Studies

Participant Group/Arms

Primary Palliative Care ConsultationExperimental

General Practitioners in the intervention FHU complete a 30hour e-learning training programme in palliative care and apply a new structured consultation model over 12 weeks (4 consultations) with recruited patients.

Other: Primary Palliative Care Complex Intervention (PrimPal)

Control (Usual Care)No Intervention

GPs in the control FHU deliver usual palliative care without specific training or structured consultation model.