An interventional study of Person-centered care intervention in Chronic Illness and Caregivers, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Supportive care
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:
Researchers will compare families who receive the PCC intervention in addition to usual care to families who receive usual care alone.
Participants will:
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).
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 722 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria for the Person with Advanced Chronic Illness:
Inclusion Criteria for the Family Caregiving Unit:
Inclusion Criteria for Individual Caregivers
Exclusion Criteria:
Participants allocated to the control group will not receive any additional intervention. They will continue to receive the standard care provided in primary care for the management of patients with advanced chronic conditions, according to routine clinical practice and regional healthcare guidelines.
The Person-Centred Care intervention will be delivered for 3 months on top of usual care.
Behavioral: Person-centered care intervention
The intervention will be delivered by primary care nurses, in coordination with doctors, social workers, and psychologists from each center. Nurses, previously trained in person-centred care, will collect the family narrative regarding their experiences, needs, goals, and available resources. Based on this, a health plan will be co-created with the family, incorporating short- and long-term objectives, concrete actions, and the supports required. The plan will be reviewed and adapted in monthly follow-up consultations during a three-month period.
Also known as: PCC
Evaluate the effect of a PCC intervention on the caregiving experience of family caregivers.
The Spanish version of the Scale for End-of-Life Caregiving Appraisal (SEOLCAS) (Hernández-Padilla et al., 2019) will be used. This instrument comprehensively assesses caregivers' experience at the end of life across four domains: physical suffering, caregiving burden, positive appraisal of caregiving, and social support seeking. It comprises 14 items, with total scores categorized as: "low impact" (0-17 points), "moderate impact" (18-40 points), and "high impact" (41-56 points). The Spanish adaptation has demonstrated good internal consistency (α = 0.92).
Time frame: Baseline, 3, 9 months
Evaluate the effect of a PCC intervention on caregivers' preparedness to provide care.
The Spanish version of the Caregiver Preparedness Scale (CPS) (Gutierrez-Baena \& Romero-Grimaldi, 2021) will be employed. It consists of 8 items evaluating the preparedness of caregivers of vulnerable older adults living at home. Each item is scored on a 5-point Likert scale ranging from 0 (not at all prepared) to 4 (very well prepared), with a total score ranging from 0 to 32; higher scores indicate greater preparedness. The CPS has shown good internal consistency (α = 0.89).
Time frame: Baseline, 3, 9 months
Evaluate the effect of a PCC intervention on caregivers' levels of anxiety and depression.
The Spanish version of the Hospital Anxiety and Depression Scale (HADS) (Terol-Cantero et al., 2015) will be used. The instrument consists of 14 items with two subscales: anxiety and depression. Items are rated on a 4-point Likert scale, with higher scores indicating greater severity. Total scores are categorized as: "normal" (0-7), "borderline" (8-10), and "clinical problem" (\>11). The Spanish adaptation has been validated in several populations (Costa-Requena et al., 2009; Vallejo et al., 2012), demonstrating good internal consistency (α = 0.83 for anxiety, α = 0.87 for depression) and sensitivity (0.74-0.84) and specificity (0.78-0.80) ranges (Galindo-Vázquez et al., 2015).
Time frame: Baseline, 3, 9 months
Evaluate the effect of a PCC intervention on the perceived burden of family caregivers.
The Spanish version of the Zarit Burden Interview (ZBI) (Martín et al., 1996; Odriozola-Gojenola et al., 2008) will be used. This multidimensional questionnaire (physical, emotional-psychological, social, and economic) consists of 22 items rated on a 5-point Likert scale from 0 = "never" to 5 = "almost always." The total score ranges from 22 to 110, classified as: "no burden" (≤46), "mild burden" (47-55), or "severe burden" (≥56). The ZBI has demonstrated high internal consistency (α = 0.92), sensitivity of 98.5%, and specificity of 93.9% (Gort et al., 2005).
Time frame: Baseline, 3, 9 months
Evaluate the effect of a PCC intervention on the quality of life of family caregivers.
The Spanish version of the Short Form-12 Health Survey (SF-12) (Alonso et al., 1995; Vilagut et al., 2013) will be used. This instrument comprises 12 items assessing both positive and negative health states across the following domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Vilagut et al. (2005) reported adequate consistency, with α \> 0.9 for the subscales of physical functioning, role physical, and role emotional, and α = 0.7 for the remaining subscales.
Time frame: Baseline, 3, 9 months
Evaluate the effect of a PCC intervention on the rate of unplanned hospital admissions.
The rate of unplanned hospital admissions related to advanced illness during the intervention and follow-up period will be collected by the assigned nurse from the patient's medical record.
Time frame: Baseline, 3, 9 months
Evaluate the effect of a PCC intervention on the number of unplanned home or primary care visits.
The number of unplanned home or primary care visits during the intervention and follow-up period will be extracted from the patient's medical record by the assigned nurse.
Time frame: Baseline, 3, 6 months
Evaluate the effect of a PCC intervention on the place of death of patients with advanced illness.
Death due to any cause and the place where it occurred (healthcare institution or home) will be collected by the assigned nurse from the patient's medical record.
Time frame: Baseline, 3, 6 months
Plan to share: No
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Clinica Universidad de Navarra, Universidad de Navarra