The goal of this clinical trial is to learn if a Person-Centred Care (PCC) intervention can improve the caregiving experience and wellbeing of families who provide home care for a loved one with advanced chronic illness. The main questions it aims to answer are:

• Does the PCC intervention improve families' caregiving experience, preparedness for caregiving, and psychological wellbeing?
• Is the PCC intervention feasible and acceptable for implementation in primary care settings?

Researchers will compare families who receive the PCC intervention in addition to usual care to families who receive usual care alone.

Participants will:

• Take part in an initial in-person consultation with a primary care nurse to share their family caregiving experience and co-create a personalized health plan.
• Have monthly follow-up contacts with the same nurse over a 3-month period to update and adapt the plan.
• Receive a copy of the updated plan after each contact to guide caregiving and support decision-making.

BACKGROUND:

More than 4.4 million decedents in Europe experience serious health-related suffering and require palliative care, a number projected to grow globally (Arias-Casais et al., 2019). Although hospital deaths still predominate, deaths at home are steadily increasing (Morris et al., 2015). Importantly, many hospital deaths occur contrary to patients' preferences, as most people would prefer to die at home supported by family (Ali et al., 2019; Gomes et al., 2013; Higginson et al., 2017). In parallel, home-based end-of-life care has expanded in recent years (Arias-Casais et al., 2020; Kjellstadli et al., 2018; Nilsson et al., 2017).

The feasibility of remaining at home near the end of life depends largely on families' capacity to assume caregiving responsibilities (Dowd et al., 2023; Martín-Martín et al., 2022). Family members typically provide most physical and emotional care, symptom management, and service coordination, effectively becoming the backbone of home end-of-life care and delivering ~80% of care for patients with advanced illness at home (Zavagli et al., 2019; Stajduhar, 2013; Martín-Martín et al., 2016; Morris et al., 2015). While home care can foster autonomy, freedom, and meaning (Collier et al., 2015; Akpan-Idiok & Anarado, 2014), it also imposes substantial physical, psychological, and emotional strain on families, who frequently feel unprepared and lack confidence for these roles (Martín-Martín et al., 2016; Mason & Hodgkin, 2019; Soroka et al., 2018).

Health professionals play a crucial role in enabling families to provide sustainable home care in line with preferences for place of care and death (Ewing et al., 2018; Hardy, 2018). Yet family-centred practice often remains aspirational: many services still focus primarily on the patient, and professionals may be unsure how to engage families effectively (Ellington et al., 2018; Lees et al., 2014). Moreover, most research to date has emphasized the individual "primary caregiver," overlooking the broader family unit despite evidence that advanced illness constitutes a family-level crisis requiring collective adjustment during dying and into bereavement (Steele & Davies, 2015; Martín-Martín et al., 2022, 2025; Mehta et al., 2009).

Person-Centred Care (PCC) offers a coherent response. Major organizations-including WHO and the National Academy of Medicine-call for systems that centre the person (and family) rather than the disease (OMS, 2017; Pronovost et al., 2018). Spanish and regional initiatives have similarly promoted person- and family-centred practice and humanization of care (Asociación Profesional de Enfermeras de Ontario, 2015; Departamento de Salud, 2018). PCC, particularly the University of Gothenburg Centre for Person-Centred Care (GPCC) model, organizes care around narratives, shared goals, partnership, and co-creation of a health plan (Ekman et al., 2011; Britten et al., 2020). This approach reframes families as active partners with resources and capabilities, enhancing self-efficacy and participation in decision-making and care planning (Dewing et al., 2021; Barr & Tsai, 2021). Prior frameworks emphasize relational processes and contexts (McCormack & McCance, 2006; Leplège et al., 2007).

Evidence across conditions and settings indicates that PCC can improve self-efficacy, reduce uncertainty and fatigue, shorten hospital stays, lower costs and readmissions, and increase adherence and satisfaction-with signals of cost-effectiveness relative to usual care (Ekman et al., 2012; Dudas et al., 2013; Fors et al., 2017, 2018a; Wallström et al., 2020; Hansson et al., 2016; Sahlen et al., 2016; Brännström & Boman, 2014; Markgren et al., 2019; van Diepen et al., 2020; Leask et al., 2019; Skivington et al., 2024). In advanced illness at home, aligning care with needs and expectations has been associated with improved experiences and outcomes (Ekman et al., 2011; Brännström & Boman, 2014). However, rigorously designed interventions explicitly targeting family units at the end of life remain scarce.

Against this backdrop, the HELP-F project co-designed a PCC intervention tailored to families caring for a loved one with advanced non-oncologic chronic disease at home. A systematic review informed preliminary design, which was then refined via co-design with researchers, primary care professionals, and family caregivers to ensure contextual fit and acceptability (Skivington et al., 2024; Webb et al., 2019).

OBJECTIVES:

General objective: Co-design and pilot a PCC intervention to improve the caregiving experience of families providing home care to a loved one near the end of life, and evaluate feasibility and acceptability of implementation in routine primary care (Asociación Profesional de Enfermeras de Ontario, 2015; Ekman et al., 2011; Britten et al., 2020).

Specific objectives: (1) Co-design the PCC intervention drawing on current evidence and collaboration among researchers, clinicians, and families (Skivington et al., 2024; Webb et al., 2019); (2) Train and assess nurses' PCC competencies as leaders of the intervention (Carvajal-Valcárcel et al., 2024); (3) Explore feasibility and acceptability of implementation from the perspective of intervention nurses to inform a future large-scale RCT (Leask et al., 2019; Skivington et al., 2024).

DESIGN:

Pilot, open-label, multicentre, parallel-group randomized controlled trial with a superiority framework and intention-to-treat comparison (Christensen, 2007; Shah, 2011). Given the risk of contamination, randomization occurs at the cluster (primary care centre) level. The study follows Medical Research Council guidance for development and evaluation of complex interventions; the intervention is considered complex due to multiple interacting components, required skills, heterogeneity of contexts, and the need for flexible tailoring (Skivington et al., 2021, 2024).

SETTING:

Primary Care centres within the public network of the Pamplona health area (Navarra, Spain).

PARTICIPANTS AND RECRUITMENT:

Investigator nurses at participating centres will screen primary care records to identify patient-family units receiving home-based care for advanced chronic disease. Patients will be approached during routine clinic or home visits (or by telephone) to confirm caregiver identification and interest; caregivers will then be contacted, provided study information, and invited to participate. Consent will be obtained prior to any study-related procedures. Cluster allocation (centre = intervention vs control) will be determined before enrolment to guide site-level implementation and minimize cross-arm contamination (Webb et al., 2019; Skivington et al., 2024).

CO-DESIGN OF IMPLEMENTATION A preliminary logic model, derived from the literature and early design work, was iteratively refined through a stakeholder co-design process-including researchers, Navarra primary care professionals, and family caregivers-following best practice to optimize contextual fit, feasibility, and acceptability (Webb et al., 2019; Skivington et al., 2024). Inputs from this process informed practical delivery details (roles, workflows, materials) and anticipated barriers/facilitators within routine primary care.

INTERVENTION Overview and team. The intervention adapts the GPCC PCC model for family units in home end-of-life care (Britten et al., 2020; Ekman et al., 2011). It is led by primary care nurses with support, when indicated, from medicine, social work, and psychology, all operating within a PCC framework (McCormack & McCance, 2006; Leplège et al., 2007).

Preparation and training. Prior to implementation, intervention nurses will complete a 12-hour, in-person training covering PCC principles (GPCC), person-centred communication, motivational/coaching strategies, and the impact of advanced illness on patients, families, and communities. Interactive, practice-oriented methods will be used. During the pilot, monthly micro-refreshers ("training pills") will be emailed to reinforce fidelity. PCC competence will be assessed pre- and post-pilot using the Spanish PCPI-S (Carvajal-Valcárcel et al., 2024).

Core PCC components: (a) Partnership establishment: Nurse and family (and patient, where appropriate) engage as co-experts-family in lived experience; nurse in disciplinary knowledge (Ekman et al., 2011); (b) Narrative elicitation: Using open questions, reflections, and summaries, the nurse facilitates a family narrative about everyday life, caregiving challenges, resources, and priorities (Ekman et al., 2011; Fors et al., 2018b); (c) Co-creation of a personalized health plan: Together they document key topics, short- and long-term goals, concrete actions (what/how/when), internal/external resources, and needed supports (who/how/when). Where relevant, the nurse coordinates with medicine, social work, and psychology to align inputs (Britten et al., 2020; Dewing et al., 2021; Barr & Tsai, 2021).

Contact structure and documentation. An initial in-person consultation initiates the partnership, narrative, and plan; subsequent monthly contacts with the same nurse review and refine the plan, which is shared with families in print or via email to strengthen commitment and continuity (Ekman et al., 2011; Fors et al., 2018b).

FEASIBILITY AND ACCEPTABILITY EVALUATION After the pilot, a structured focus group with intervention nurses-facilitated by the doctoral researcher and a thesis supervisor-will explore implementation feasibility, acceptability, fidelity, contextual barriers/facilitators, strengths, and improvement opportunities, using a predefined guide and qualitative content analysis to inform refinements for a future definitive trial (Leask et al., 2019; Skivington et al., 2024; Elo & Kyngäs, 2008).

Inclusion Criteria:

1. Inclusion Criteria for the Person with Advanced Chronic Illness:

   • Diagnosis of an advanced chronic disease, such as chronic heart failure (NYHA functional class IV), renal failure (stages 4-5), chronic obstructive pulmonary disease (COPD) (grades 4-5 on the MRC scale), or liver failure.
   • Not currently receiving care from a specialized palliative care team.
   • Habitual residence in their own home or that of a family member, without requiring permanent hospitalization.

2. Inclusion Criteria for the Family Caregiving Unit:

   • Actively providing care at home to an adult with advanced illness at the time of the study.
   • A minimum of two months must have elapsed since the initiation of family caregiving for the person with advanced chronic illness at home.
   • At least two or more adult family members of the person with advanced illness must participate in the study.

3. Inclusion Criteria for Individual Caregivers

   • Recognized as a caregiver by the person with advanced chronic illness.
   • Aware of the advanced illness diagnosis of the care recipient.
   • Aged 18 years or older.
   • Able to communicate in Spanish.
   • Having the physical and mental capacity to participate in the interview.
   • Willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

• Life expectancy of less than one year
• Families experiencing an acute crisis situation (e.g., recent bereavement, severe family conflict).

The nature of the intervention means that neither participants nor the health care professionals in the HELP-F intervention can be blinded to allocation in the RCT.