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

Conditions

• Brain (Nervous System) Cancers
• Brain Injuries, Acute
• Brain Tumor Adult
• Glioblastom WHO Grade 4
• Glioblastoma (GBM)
• Stroke
• Traumatic Brain Injuries

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Supportive Care — OTHER
  The intervention uses a stepped-care model to support relatives based on their level of burden and support needs. All participants receive basic support, and additional support is offered step-by-step when needed. Step 1 - Usual Care and Screening All relatives receive usual care and basic information. Caregiver burden is screened using the 4-item Zarit Burden Interview (ZBI-4). Step 2 - Structured Support Relatives who screen positive on the ZBI-4 are offered a structured PIRe conversation with a nurse. The conversation focuses on the relative's role, needs, and wishes for involvement, as well as providing better overview of the care pathway. Step 3 - Extended Support Relatives with increased burden, based on ZBI-4 results and clinical assessment, receive extended and more targeted support, including follow-up conversations and improved coordination between hospital and community services. Step 4 - Specialized Support Relatives with high burden or complex needs receive specialized sup

Study Details

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.

Key Dates

First listed

May 15, 2026

Start date

Oct 1, 2026

Status verified

May 2026

Primary completion

Apr 1, 2027

Completion

Sep 30, 2029

Study Design

Enrollment

160 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: PIRe Stepped-Care Intervention
  Participants receive the PIRe intervention delivered within a stepped-care model targeting primary relatives of patients with acquired brain injury (ABI) or malignant brain tumor (MBT). All receive usual care (information and initial screening using Zarit-4). Based on screening and clinical assessment, support is escalated: Step 2 includes a structured PIRe conversation and needs assessment; Step 3 involves extended support and cross-sectoral coordination; Step 4 provides specialized interventions (e.g., neuropsychological support). The model enables tailored, progressive support according to caregiver burden.
• No Intervention: Usual Care
  Participants receive standard care corresponding to Step 1 of the stepped-care model, including general information and no structured PIRe intervention or systematic escalation of support.

Primary Outcome Measure

Caregiver Burden Scale [ Time Frame: The outcome is reported as the change in caregiver burden from baseline to 3-6 months after the intervention. ]

Central Contacts

• Rikke Guldager, PhD
  0045 51199727
  [email protected]
• Ingrid Poulsen, Professor
  004541277383
  [email protected]

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