Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale (CARE-SAFE)

Comprehensive Assessment of Rehabilitation Experience Using the Social And Family Evaluation (SAFE) Scale

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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Brain Injury; Caregiver Satisfaction and Connectedness to Clinic; Therapeutic Alliance; Disorders of Consciousness Due to Severe Brain Injury; Caregiver Anxiety
• Intervention / Treatment: Behavioral: Caregiver training and administration of SAFE scale; Other: Standard clinical care

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiara Fanciullacci; Phone Number: +39 3937317440; Email: cfanciullacci@dongnocchi.it

Study Locations

• Italy
  • Florence, Italy, 50143
    • Recruiting
    • IRCCS Fondazione Don Gnocchi
    • Contact: Chiara Fanciullacci; Phone Number: +39 3937317440; Email: cfanciullacci@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAFE Group; Participants allocated to the SAFE group will undergo an individual training session with the healthcare professionals involved in the study. During this session, the SAFE scale and its administration procedures will be explained in detail. According to the procedures established for the SAFE scale, caregivers will complete the scale after a 2-week observation period of the patient's behaviours (T1). The SAFE scale will then be completed again by the caregiver 4 weeks after the first administration (corresponding to 6 weeks after the initial training session performed at baseline, T2). Caregivers will be asked to complete also the following questionnaire: Brief Illness Perception Questionnaire (BIPQ; Broadbent et al., 2006)	Behavioral: Caregiver training and administration of SAFE scale; The intervention will consist of caregiver training and completion of the SAFE scale (Magnani et al., 2025). The SAFE is an observational tool developed to allow caregivers of patients with Disorders of Consciousness (DoC) to systematically report cognitively mediated behaviours based on daily interactions with the patient over the previous two weeks. Derived from the Coma Recovery Scale-Revised (CRS-R; Giacino et al., 2020), the SAFE includes simplified items designed for non-professional users. Preliminary results have shown good reliability, internal consistency, and correlation with the CRS-R. Following a standardized explanation provided by trained clinicians, caregivers will complete the scale by reporting behaviours observed during the previous 15 days. For each item, caregivers will answer "Yes" or "No" regarding the presence of a specific voluntary/non-reflexive behaviour associated with sensory or cognitive domains.; Other Names: scale administration
Active Comparator: No SAFE Group; Participants allocated to the NO-SAFE group will receive the standard clinical care provided by the rehabilitation unit. They will receive the Fondazione Don Gnocchi educational booklet "Il paziente con GCA: guida per le famiglie" as the minimum psychoeducational intervention. Two weeks after enrolment and delivery of the educational booklet, caregivers will be asked to complete the following questionnaire: Brief Illness Perception Questionnaire (BIPQ; Broadbent et al., 2006).	Other: Standard clinical care; Caregivers allocated to the NO-SAFE group will receive the standard clinical care provided by the rehabilitation unit. They will receive the Fondazione Don Gnocchi educational booklet "Il paziente con GCA: guida per le famiglie" as the minimum psychoeducational intervention and will participate in routine clinical meetings with the physicians of the rehabilitation unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregivers' Perceived Understanding of Their Relative's Clinical Condition	Measure: The primary endpoint is the score on the Illness Coherence item of the Brief Illness Perception Questionnaire (BIPQ; Broadbent et al., 2006) at T2. This item assesses caregivers' perceived understanding of their relative's clinical condition in the context of Disorders of Consciousness (DoC). The item is scored on a scale from 0 to 10, with higher scores indicating greater perceived understanding of the clinical condition (better outcome).	6 weeks from the enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Satisfaction with Care	Measure: Family Satisfaction in the Intensive Care Unit (FS-ICU; Heyland & Tranmer, 2001; Italian version: Pagnamenta et al., 2016; Danielis et al., 2023). Family satisfaction with the patient's care pathway will be assessed using the Family Satisfaction in the Intensive Care Unit (FS-ICU). The overall score ranges from 0 to 100, with higher scores indicating greater satisfaction with care (better outcome).	10 weeks from the enrollment (T3)
Decisional Conflict	Measure: Decisional Conflict Scale (DCS; O'Connor, 1993; Chiavari et al., 2013; Esposito et al., 2020). Decisional conflict will be assessed using the Decisional Conflict Scale (DCS). The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict and uncertainty (worse outcome).	10 weeks after enrollment (T3)
Depressive Symptoms	Measure: Beck Depression Inventory-II (BDI-II; Beck et al., 1996; Steer, 1999; Ghisi et al., 2006). Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report measure. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms (worse outcome).	From baseline (T0) to 10 weeks after enrollment (T3)
State Anxiety	Measure: State-Trait Anxiety Inventory - Form Y, State Anxiety subscale (STAI-Y; Spielberger et al., 1997). State anxiety will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory - Form Y (STAI-Y). The subscale score ranges from 20 to 80, with higher scores indicating greater state anxiety (worse outcome).	From baseline (T0) to 10 weeks after enrollment (T3)
Trait Anxiety	Measure: State-Trait Anxiety Inventory - Form Y, Trait Anxiety subscale (STAI-Y; Spielberger et al., 1997). Trait anxiety will be assessed using the Trait Anxiety subscale of the State-Trait Anxiety Inventory - Form Y (STAI-Y). The subscale score ranges from 20 to 80, with higher scores indicating greater trait anxiety (worse outcome).	From baseline (T0) to 10 weeks after enrollment (T3)
Prolonged Grief Symptoms	Measure: Prolonged Grief Disorder-12 (PG-12; Prigerson et al., 2009). Prolonged grief symptoms will be assessed using the Prolonged Grief Disorder-12 (PG-12). The PG-12 is a self-report measure assessing symptoms of prolonged grief. The total score ranges from 11 to 55, with higher scores indicating greater severity of prolonged grief symptoms (worse outcome).	From baseline (T0) to 10 weeks after enrollment (T3)
Caregiver Strain	Measure: Family Strain Questionnaire (FSQ; Vidotto et al., 2009). Caregiver strain will be assessed using the Family Strain Questionnaire (FSQ). The total score ranges from 0 to 30, with higher scores indicating greater caregiver strain and psychological burden (worse outcome).	From baseline (T0) to 10 weeks after enrollment (T3)

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi ETS
• Investigators: Principal Investigator: Bahia Hakiki, IRCCS Fondazione Don Gnocchi

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2026
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): July 15, 2029

Study Registration Dates

• First Submitted: September 25, 2026
• First Submitted That Met QC Criteria: October 27, 2026
• First Posted (Actual): November 3, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: October 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Coma Recovery Scale - Revised; Social and Family Evaluation; Caregivers' illness perceptions
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: CARE-SAFE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No