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.
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.
Actively providing care at home to an adult with advanced illness at the time of the study.
Life expectancy of less than one year
Families experiencing an acute crisis situation (e.g., recent bereavement, severe family conflict).
Parallel
Person-centered care intervention
BehavioralThe 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.
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).
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).
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).
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).
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.
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.
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.
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.
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Clinica Universidad de Navarra, Universidad de Navarra
Lead sponsor
University of Navarra
Collaborator
Navarre Health Research Institute (IdiSNA), Spain
Collaborator
Göteborg University
Collaborator
Departamento de Salud del Gobierno de Navarra
Collaborator
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