Caregivers and patients with severe brain injury: using the SAFE scale to monitor behavior together

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study centers on caregivers of adults with severe acquired brain injury and disorders of consciousness. Caregivers will be trained to administer the SAFE scale alongside standard clinical care to report observable patient behaviors. The aim is to enhance communication between families and the rehabilitation team and improve the continuity of behavioral monitoring. The trial combines caregiver observations with routine assessments to see if it clarifies the patient’s clinical trajectory. The approach is designed to complement, not replace, clinician-administered evaluations.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Fondazione Don Gnocchi
  Florence, Italy Recruiting

Study contacts

• Principal investigator: Bahia Hakiki — IRCCS Fondazione Don Gnocchi
• Study coordinator: Chiara Fanciullacci
• Email: cfanciullacci@dongnocchi.it
• Phone: +39 3937317440

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.