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

NCT07184216 | Not Yet Recruiting

• 1 other identifier: HELP-F Study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Illness; Caregivers

Keywords

Person-centredness; RCT; Partnership; Health plan; Person-centred care; Person-centered care; Patient-centered care; Home care; In-home care; Home-based care; Community home care; Carers; Family caregivers; Informal caregivers; Care providers

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline, 3, 9 months

Secondary Outcomes (3)

• Evaluate the effect of a PCC intervention on caregivers' levels of anxiety and depression.

  Baseline, 3, 9 months

• Evaluate the effect of a PCC intervention on the perceived burden of family caregivers.

  Baseline, 3, 9 months

• Evaluate the effect of a PCC intervention on the quality of life of family caregivers.

  Baseline, 3, 9 months

Other Outcomes (3)

• Evaluate the effect of a PCC intervention on the rate of unplanned hospital admissions.

  Baseline, 3, 9 months

• Evaluate the effect of a PCC intervention on the number of unplanned home or primary care visits.

  Baseline, 3, 6 months

• Evaluate the effect of a PCC intervention on the place of death of patients with advanced illness.

  Baseline, 3, 6 months

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

The Person-Centred Care intervention will be delivered for 3 months on top of usual care.

Behavioral: Person-centered care intervention

Interventions

Person-centered care intervention BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• University of Navarra: collaborator
• Navarre Health Research Institute (IdiSNA), Spain: collaborator
• University of Gothenburg Center for Person-Centred Care, GPCC: collaborator
• Departamento de Salud del Gobierno de Navarra: collaborator

Study Sites (1)

Universidad de Navarra, Facultad de Enfermería

Pamplona, Navarre, 31008, Spain

Location

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MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jesús Martín

CONTACT

(+34) 948 425600; jmartinm@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Family caregivers of patients with advanced chronic illness who meet the inclusion criteria and provide informed consent will be randomized. Randomization will be conducted at the primary care center level by research nurses, following a computer-generated sequence, with a 1:1 allocation. Centers will be assigned to either the control or intervention group. The control group will receive usual care, while the intervention group will receive a three-month person- and family-centered care intervention, in addition to usual care.

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)