Status:
NOT_YET_RECRUITING
Effect of a Person-Centred Care Intervention for Families Providing Home-Based Care to a Person With Advanced Chronic Illness: A Pilot Randomised Controlled Trial
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsors:
University of Navarra
Navarre Health Research Institute (IdiSNA), Spain
Conditions:
Chronic Illness
Caregivers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 advan...
Detailed Description
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). Althoug...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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
- Life expectancy of less than one year
- Families experiencing an acute crisis situation (e.g., recent bereavement, severe family conflict).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07184216
Start Date
October 1 2025
End Date
June 30 2026
Last Update
September 19 2025
Active Locations (1)
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1
Universidad de Navarra, Facultad de Enfermería
Pamplona, Navarre, Spain, 31008