Clinical trial · Observational
Development and Implementation of an Intervention Enhancing Involvement of Relatives to Patients With Acquired Brain Injury or Malignant Brain Tumour
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injury | — | UNRESOLVED | — |
| Brain Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Traumatic Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RIGht | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ABI (Aquired Brain Injury)
- interventionNames
- Other: RIGht
- label
- ABI (Aquired Brain Injury), MBT (Malignant Brain Tumor)
- description
- 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.
- interventionNames
- Other: RIGht
Primary outcomes (1)
- measure
- Focus group interviews
- timeFrame
- Op til 6 weeks post intervention
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Relatives under the age of 18 years of age
References
Publications (5)
- BACKGROUNDGuldager 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
- BACKGROUNDGuldager 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
- RESULTGuldager 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
- RESULTLundh 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
- RESULTGuldager 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