Development and Implementation of an Intervention Enhancing Involvement of Relatives to Patients With Acquired Brain Injury or Malignant Brain Tumour

NCT06796335 | Completed

• 1 other identifier: ID P-2022-733
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Caring for a loved one with a serious illness like acquired brain injury (ABI) or primary malignant brain tumors (PMBT) can be a challenging and burdensome experience, often affecting the well-being and quality of life of relatives. While family and friends can provide some support, this is not always enough to address the diverse needs of caregivers. Relatives often have different requirements for support, information, and involvement in the patient's care. Understanding these varying needs is key to ensuring both the patient and their caregivers are effectively supported during the illness journey. This study aims to develop and test an intervention that helps healthcare professionals better support relatives in their caregiving role. The intervention uses a dialogue tool, which is designed to help nurses assess and follow up on the differing needs of relatives for involvement in the care of patients with ABI and PMBT. The goal is to enhance the experience of both the patient and their caregivers throughout the illness process. The study will take place across seven units in two regions of Denmark, and it involves relatives of patients with ABI or PMBT. The main questions the study aims to answer are:

• Can an intervention that involves relatives improve their role in the care of patients with ABI and PMBT?
• Will this intervention help both patients and their relatives feel more supported and satisfied during the treatment process? Participants will receive support through an intervention that includes several key components:
• Nurse training on how to use the dialogue tool to assess and address the varying needs of relatives for involvement.
• A list created by relatives, for relatives, to share experiences and advice with one another.
• Video materials explaining the background and purpose of the intervention to help relatives understand how it can benefit them.
• Guidelines for documenting the involvement of relatives in the patient's electronic health record. By offering targeted support to relatives, this intervention aims to enhance their involvement in the treatment process, ensuring that both patients with ABI or PMBT and their families are better supported throughout the course of the illness.

Conditions

Brain Injury; Brain Tumor Adult; Traumatic Brain Injury; Glioblastoma

Keywords

Involvement; Relatives; Complex intervention; Qualitative research; nurse intervention; tool; dialog

Outcome Measures

Primary Outcomes (1)

• Focus group interviews

  Themes describing nurses evaluation of the acceptability and fidelity of the intervention will be evaluated i through qualitative focus group interviews. A Thematic analysis as suggested by Braun and Clark will be conducted.

  Op til 6 weeks post intervention

Secondary Outcomes (2)

• PEIRS-22

  Op til 6 weeks post intervention

• Semi-structured interviews

  Op til 10 weeks post intervention

Study Arms (2)

ABI (Aquired Brain Injury)

Other: RIGht

ABI (Aquired Brain Injury), MBT (Malignant Brain Tumor)

The study will be conducted in six inpatient units in two hospice sites in Denmark that admitted adult patients with respectively acquired brain injury and malignant brain tumor.

Other: RIGht

Interventions

RIGht OTHER

The final intervention consists of five components; 1) education of nurses 2) a dialog tool used in a single session intervention and follow- up 3) a relative- to- relative list 4) video material 5) guidelines on how to document the relative involving plan in the patient's electronic journal.

ABI (Aquired Brain Injury); ABI (Aquired Brain Injury), MBT (Malignant Brain Tumor)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study is conducted in six inpatient units in two hospice sites in Denmark that admitted adult patients with respectively acquired brain injury and malignant brain tumor. Acquired brain injuries often occur suddenly and unexpectedly. Suffering from an acquired brain injury has major consequences, not only for the patients, due to the devastating impact on their physical, cognitive, social, and psychological well-being, but also for the relatives who may need to take on a lifelong role as carers

You may qualify if:

• Relatives of adult patients with an acquired brain injury or primary malignant brain tumor
• Patients most be hospitalized
• Patients must agree to give their informed consent to involve their relatives
• Able to read and understand english

You may not qualify if:

• Relatives under the age of 18 years of age

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Hvidovre University Hospital: collaborator
• Regionshospitalet Hammel Neurocenter: collaborator

Study Sites (1)

Department of neurosurgery, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (5)

• 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, 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

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Glioblastoma; Margins of Excision

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nursing Research

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 28, 2025
• Study Start: October 10, 2024
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 7, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)