Clinical trial · Interventional
SAFIR© : An Early Intervention for Supporting Families of Patients With Acquired Brain Injuries
A Feasibility Study on the Newly Developed Early Intervention for Families of Patients With Acquired Brain Injuries: SAFIR©
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pandemic of SARS-CoV2
Summary
Brief summary (as posted)
The aim of the study is to evaluate the feasibility of a newly developed intervention to improve family support for patient with acquired brain injury (ABI) in early phase of hospitalization (SAFIR): the main components are the assessment of the family, the emotional support for the families, the information giving to the families, the inclusion of the families in the care process and the care coordination between the inter professional team. The main outcomes of the study are feasibility and acceptability outcomes of the newly developed intervention, and trend in efficacy in the family functioning, coping and perceived support from the nurses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acquired Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAFIR© | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- interventional
- description
- All the participants will received the full SAFIR. SAFIR is composed with 5 core components: 1) assessment of the family, 2) emotional support, 3) information, 4) family engagement, 5) care coordination. Each family will participate in 3 structured family meetings, with a follow-up at 30 days. During each meeting, every core component will be delivered but their dose will be adapted following the priorities of the families.
- interventionNames
- Other: SAFIR©
Primary outcomes (1)
- measure
- Fidelity of the SAFIR intervention delivery: fidelity checklist and dashboard.
- timeFrame
- 6 months
- description
- Fidelity will be assessed via a fidelity to protocol checklist and a dashboard recording the ability of the CNS to carry out the intervention regarding the context
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients (P): inclusion criteria for patient are to be older than 18 years, being diagnosed with moderate to severe ABI by medical doctors, which means leading to a Clinical Rehabilitation Center, and being hospitalized for a minimum of 1 days. 2. Family members (FM): inclusion criteria for family members are having a relationship with the patient or to be close unrelated but considered significant for the patient by the patient or the legal representative. 3. Clinical Nurse Specialist (CNS): inclusion criteria will be to work for at least one year in the unit, to agree to participate at the study and to follow a specific training. Exclusion Criteria: 1. Exclusion criteria for patients are being diagnosed with mild ABI by medical doctors. 2. Exclusion criteria are being unable to speak or understand French or refuse to sign the consent. 3. Exclusion criteria for CNS are to refuse to participate at the study or not to follow a specific training. \-
References
Publications (1)
- DERIVEDde Goumoens V, Bruyere K, Rutz D, Pasquier J, Bettex YO, Vasserot K, Ryvlin P, Ramelet AS. Caring for Families of Patients With Acquired Brain Injury Early During Hospitalization: A Feasibility Study of the SAFIR(c) Intervention. J Fam Nurs. 2024 Aug;30(3):255-266. doi: 10.1177/10748407241270034. PMID 39268852