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New program aims to ease burden on family caregivers of chronically ill patients

NCT ID NCT07184216

Symptom relief Sponsor: Clinica Universidad de Navarra, Universidad de Navarra Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This pilot study tests whether a person-centred care (PCC) intervention can improve the caregiving experience and wellbeing of families who provide home care for someone with an advanced chronic illness. Fifty families will be randomly assigned to receive either the PCC intervention plus usual care or usual care alone. The intervention involves an initial consultation with a primary care nurse to create a personalized health plan, followed by monthly check-ins over three months. The study focuses on whether this approach is feasible and acceptable in primary care settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Person-centred care intervention (behavioural)
What this could lead to
If it works, this could provide a practical way for primary care nurses to support family caregivers, reducing their stress and improving their caregiving experience.
What could go wrong
This is a very small pilot study (50 participants) testing feasibility, not effectiveness. The intervention may not show meaningful benefits or be too resource-intensive for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Chronic Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Caregivers Chronic illness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universidad de Navarra, Facultad de Enfermería

    Pamplona, Navarre, 31008, Spain

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