Not Yet RecruitingNot Applicable

PIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors

Denmark160 participantsStarted 2026-10-01

Plain-language summary

Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings. Despite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care. The PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a "caregiver compass" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway. PIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care. The study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention. The primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures. In addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Primary relative of an adult diagnosed with acquired brain injury (ABI) or malignant brain tumor (MBT), admitted to a participating hospital department. * Formally identified as the primary relative by the patient. * Aged ≥18 years. * Ability to read, understand, and complete questionnaires in Danish. Exclusion Criteria * Insufficient proficiency in Danish to complete questionnaires and participate in structured conversations. * Concurrent participation in another interventional study with a similar aim that may interfere with the present study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focuses on supporting family members and caregivers rather than directly treating the patient — so how would my participation or my family member's participation actually fit into our current care plan for a brain injury or tumor diagnosis?
2Since this trial is measuring something called the Caregiver Burden Scale, does that mean the main goal is to reduce stress and strain on the caregiver, and if so, what kinds of support or programs would my family actually be doing as part of the study?
3The trial isn't recruiting yet — do you know when it might open, and is there anything we should be doing in the meantime to support our family caregiver while we wait to see if this becomes an option?
4This is listed as a stepped-care model involving multiple healthcare sectors, so does that mean we'd need to coordinate across different clinics or services, and is that realistic given our current schedule and situation?
5Given that my loved one has a serious diagnosis like glioblastoma or a traumatic brain injury, are there existing caregiver support programs or standard-of-care resources we should be using now, rather than waiting for a trial that hasn't started recruiting yet?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Caregiver Burden Scale

Timeframe: The outcome is reported as the change in caregiver burden from baseline to 3-6 months after the intervention.

Trial details

NCT IDNCT07590726

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Rikke Guldager, PhD

0045 51199727 rikke.guldager.01@regionh.dk

View on ClinicalTrials.gov More Brain Injuries, Acute trials