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

NCT07590726 | Not Yet Recruiting

• 1 other identifier: P2020-547
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Acquired brain injury; Malignant brain tumor; Relatives; Caregiver Burden; Involvement; Communication; Care transitions; Rehabilitation; Implementation; Stepped-care

Outcome Measures

Primary Outcomes (1)

• Caregiver Burden Scale

  The Caregiver Burden Scale (CBS) is used to assess the level of burden experienced by caregivers. Items are rated on a scale from 1 to 4, and mean scores are calculated across items. Higher scores indicate a higher level of perceived caregiver burden (i.e., worse outcome).

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

Secondary Outcomes (3)

• Caregiver Roles and Responsibilities Scale (CRRS)

  Outcomes are assessed at baseline, at transition from hospital to community care, and at 3-6 months after the intervention.

• Involvement in Care - Family Perceived Support Questionnaire

  Outcomes are assessed at baseline, at transition from hospital to community care, and at 3-6 months after the intervention.

• Generalized Anxiety Disorder-7

  Outcomes are assessed at baseline, at transition from hospital to community care, and at 3-6 months after the intervention.

Study Arms (2)

PIRe Stepped-Care Intervention

EXPERIMENTAL

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.

Other: Supportive Care

Usual Care

NO INTERVENTION

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.

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

PIRe Stepped-Care Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Ø, 2100, Denmark

Location

Related Publications (6)

• Guldager R, Gyldenohr E, Poulsen I, Aadal L, Nordentoft S, Loft MI. Relatives' Involvement in the Care Pathway of Patients With Acquired Brain Injury or Malignant Brain Tumour: An Observational Study. Nurs Res Pract. 2026 Apr 19;2026:2280006. doi: 10.1155/nrp/2280006. eCollection 2026.

  PMID: 42016768 BACKGROUND

• Guldager R, Sejr Smedegaard P, Nordentoft S, Aadal L, Ingerslev Loft M, Poulsen I. Facilitators and Barriers of Relatives' Involvement in Care of Patients With Acquired Brain Injury or Malignant Brain Tumour: Scoping Review. Nurs Open. 2026 Jan;13(1):e70417. doi: 10.1002/nop2.70417.

  PMID: 41559742 BACKGROUND

• Lundh MG, Nordentoft S, Smedegaard PS, Aadal L, Loft MI, Poulsen I, Guldager R. Interventions facilitating the involvement of relatives of patients with acquired brain injury or malignant brain tumour: A scoping review. J Clin Nurs. 2025 Mar;34(3):784-794. doi: 10.1111/jocn.17328. Epub 2024 Jul 30.

  PMID: 39078079 BACKGROUND

• Guldager R, Nordentoft S, Poulsen I, Aadal L, Loft MI. Wants and needs for involvement reported by relatives of patients with a malignant brain tumor: a scoping review. JBI Evid Synth. 2023 Nov 1;21(11):2188-2210. doi: 10.11124/JBIES-22-00311.

  PMID: 37435678 BACKGROUND

• Guldager R, Nordentoft S, Poulsen I, Aadal L, Loft MI. Wants and needs for involvement experienced by relatives of patients with an acquired brain injury: a scoping review. JBI Evid Synth. 2023 May 1;21(5):886-912. doi: 10.11124/JBIES-22-00022.

  PMID: 36729839 BACKGROUND

• Guldager R, Nordentoft S, Aadal L, Loft MI, Poulsen I. Wants and needs of relatives' involvement in patient care: the same but different. JBI Evid Synth. 2023 Nov 1;21(11):2154-2155. doi: 10.11124/JBIES-23-00469. No abstract available.

  PMID: 37935421 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Neurologic Manifestations; Neoplasms; Brain Injuries, Traumatic; Glioblastoma; Stroke; Brain Neoplasms; Caregiver Burden; Margins of Excision; Communication

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Stress, Psychological; Behavioral Symptoms; Behavior; Morphological and Microscopic Findings

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Rikke Guldager, PhD

CONTACT

0045 51199727; rikke.guldager.01@regionh.dk

Ingrid Poulsen, Professor

CONTACT

004541277383; ingrid.poulsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MScN, PhD Head of Nursing Research

Model Details: Intervention Model Description 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 comple

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

DK (1)