Overview
Patients with severe acquired brain injury (sABI) and disorders of consciousness (DoC) require intensive interdisciplinary rehabilitation involving healthcare professionals, patients, and family caregivers. Caregivers play a key role in supporting patients and ensuring continuity of care, yet they frequently experience high levels of psychological distress, anxiety, depression, caregiver burden, and reduced quality of life. Previous studies have highlighted the need for clearer communication and greater caregiver involvement throughout the rehabilitation process.
The Social and Family Evaluation (SAFE) scale was developed to actively involve caregivers in monitoring patients with DoC. Derived from the Coma Recovery Scale-Revised (CRS-R), SAFE is a simplified, caregiver-friendly observational tool that enables family members to report clinically relevant behaviors observed during daily interactions. Preliminary validation demonstrated excellent psychometric properties, including high internal consistency, excellent test-retest reliability, and good criterion validity compared with the CRS-R. However, its effectiveness has not yet been investigated in the subacute rehabilitation setting.
The primary aim of this study is to evaluate whether the use of the SAFE scale improves caregivers' illness perceptions. Secondary objectives are to assess its impact on caregiver satisfaction with rehabilitation, decisional conflict, anxiety, depression, prolonged grief, and caregiver burden.
This is a non-profit, prospective, multicenter, single-blind randomized controlled trial involving 68 caregiver-patient dyads recruited from three intensive neurorehabilitation units of the Don Carlo Gnocchi Foundation in Florence, Milan, and Sant'Angelo dei Lombardi (Italy). Adult caregivers of patients with DoC admitted within three months after brain injury will be randomly assigned (1:1) to either the SAFE intervention group or a standard-care control group. Randomization will be stratified according to caregiver relationship (parent vs. non-parent) and patient diagnosis (vegetative state/unresponsive wakefulness syndrome vs. other DoC).
At baseline (T0), caregivers will complete the Brief Illness Perception Questionnaire (BIPQ), Family Strain Questionnaire (FSQ), Prolonged Grief Disorder-12 (PG-12), Beck Depression Inventory-II (BDI-II), and State-Trait Anxiety Inventory (STAI-Y). Patients will be assessed using the Coma Recovery Scale-Revised (CRS-R) and the Level of Cognitive Functioning (LCF).
Caregivers allocated to the SAFE group will receive standardized training on the SAFE scale and complete it at 2 weeks (T1) and 6 weeks (T2), together with repeated BIPQ assessments. Control participants will receive routine clinical care and complete the BIPQ only. Both groups will receive the same psychoeducational booklet as standard care.
At the final follow-up (T3, 10 weeks after enrollment), caregivers will repeat all baseline assessments and additionally complete the Family Satisfaction in Intensive Care Unit (FS-ICU) and the Decisional Conflict Scale (DCS). Patients will undergo repeat CRS-R and LCF assessments together with the Glasgow Outcome Scale-Extended (GOSE).
The primary endpoint is the BIPQ Illness Coherence score at T2. The primary analysis will use ANCOVA adjusted for baseline values. Based on preliminary data, 68 caregivers will be enrolled to detect a clinically meaningful difference between groups while accounting for an expected 20% dropout rate. A blinded sample-size re-estimation will be performed after recruitment of the first 30 participants.
Secondary analyses will evaluate the effects of the SAFE intervention on caregiver burden, prolonged grief, anxiety, depression, family satisfaction, and decisional conflict using adjusted statistical models.
The study is considered low risk, as all procedures are consistent with routine clinical practice. If effective, the SAFE scale may enhance caregiver understanding of the patient's condition, improve communication with the rehabilitation team, promote shared decision-making, reduce psychological distress, and support a more family-centered approach to neurorehabilitation.
Description
The diagnosis and monitoring of disorders of consciousness rely primarily on standardized behavioral assessment performed by trained clinicians. Although the Coma Recovery Scale-Revised (CRS-R) represents the current clinical reference standard, patient responsiveness may fluctuate considerably throughout the day, and clinically meaningful behaviors may occur outside scheduled assessments. Family caregivers, who spend prolonged periods with patients across different contexts, are uniquely positioned to observe subtle behavioral changes that might otherwise remain undocumented.
The Social and Family Evaluation (SAFE) scale was specifically developed to facilitate the structured collection of these caregiver observations using terminology and response options accessible to non-healthcare professionals. Rather than replacing clinician-administered assessments, SAFE is intended to complement routine neurological evaluation by promoting systematic communication between caregivers and the multidisciplinary rehabilitation team. Integrating caregiver observations into the rehabilitation pathway may improve the continuity of behavioral monitoring while fostering a shared understanding of the patient's clinical condition.
In addition to its potential diagnostic value, the structured use of SAFE may represent a communication intervention. By providing caregivers with a common framework for interpreting patient behaviors, the scale may facilitate discussions with healthcare professionals, improve understanding of the diagnostic process, and encourage more active participation in rehabilitation. These mechanisms are expected to influence caregivers' illness perceptions, reduce uncertainty surrounding the patient's condition, and strengthen therapeutic alliance with the rehabilitation team.
This study will also provide evidence regarding the feasibility of implementing SAFE within intensive neurorehabilitation units during the subacute phase following severe acquired brain injury. The findings will contribute to understanding whether a standardized caregiver-reported assessment can be integrated into routine clinical practice while supporting family-centered care and enhancing communication between families and healthcare professionals.
Eligibility
Caregiver Inclusion Criteria:
- Age ≥18 years.
- Being the primary informal caregiver (regularly spending time with the patient, being aware of the patient's clinical condition, and participating in meetings with the healthcare team).
- Adequate understanding and ability to communicate in Italian.
- Provision of written informed consent.
Caregiver Exclusion Criteria:
- Previous psychiatric and/or neurological disorders.
Patient Inclusion Criteria:
- Age ≥18 years.
- Documented diagnosis of Disorders of Consciousness (DoC) assessed by the Coma Recovery Scale-Revised (CRS-R).
- Time since the acute event \<3 months.
- Clinical stability of the patient.
- Provision of written informed consent by the legal representative.
Patient Exclusion Criteria:
None.
