Caregiver AnxietyCARE-SAFENCT07912372
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
A study testing Caregiver training and administration of SAFE scale and Standard clinical care in people with Caregiver Anxiety and Acquired Brain Injury, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Patients with severe acquired brain injury (sABI) and disorders of consciousness (DoC) require intensive interdisciplinary rehabilitation involving healthcare professionals, patients, and family caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Anxiety, Acquired Brain Injury, Caregiver Satisfaction and Connectedness to Clinic
- What is being tested?
- Caregiver training and administration of SAFE scale and Standard clinical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2026to 15 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Don Gnocchi
Florence, 50143
Chiara Fanciullacci, +39 3937317440, cfanciullacci@dongnocchi.it
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Caregiver Anxiety, Acquired Brain Injury, Caregiver Satisfaction and Connectedness to Clinic, Disorders of Consciousness Due to Severe Brain Injury, Therapeutic Alliance
- Being tested
- Caregiver training and administration of SAFE scale, Standard clinical care
- Keywords
- Coma Recovery Scale - Revised, Social and Family Evaluation, Caregivers' illness perceptions
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver training and administration of SAFE scaleBehavioural
Also called scale administration
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.
Standard clinical careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SAFE Group | Experimental | 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) Receives: Behavioral: Caregiver training and administration of SAFE scale |
| No SAFE Group | Active comparator | 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). Receives: Other: Standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks from the enrollment
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From baseline (T0) to 10 weeks after enrollment (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start15 Jul 2026
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver AnxietyStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bahia Hakiki, Principal investigator, IRCCS Fondazione Don Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912372
- Sponsor's protocol ID
- CARE-SAFE
- Acronym
- CARE-SAFE
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Rehabilitation Experience Using the Social And Family Evaluation (SAFE) Scale
- ClinicalTrials.gov ID
- NCT07912372
- Acronym / sponsor ID
- CARE-SAFE / CARE-SAFE
- Conditions
- Caregiver Anxiety, Acquired Brain Injury, Caregiver Satisfaction and Connectedness to Clinic, Disorders of Consciousness Due to Severe Brain Injury, Therapeutic Alliance
- Keywords
- Coma Recovery Scale - Revised, Social and Family Evaluation, Caregivers' illness perceptions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFE Group | Experimental | Behavioral: Caregiver training and administration of SAFE scaleParticipants 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) |
| No SAFE Group | Active comparator | Other: Standard clinical careParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver training and administration of SAFE scaleAlso: scale administrationThe 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. | Behavioural | SAFE Group |
| Standard clinical careCaregivers 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. | Other | No SAFE Group |
Primary outcome
Caregivers' Perceived Understanding of Their Relative's Clinical Condition
Time frame: 6 weeks from the enrollment
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).
7 secondary outcomes
Family Satisfaction with Care
Time frame: 10 weeks from the enrollment (T3)
Decisional Conflict
Time frame: 10 weeks after enrollment (T3)
Depressive Symptoms
Time frame: From baseline (T0) to 10 weeks after enrollment (T3)
State Anxiety
Time frame: From baseline (T0) to 10 weeks after enrollment (T3)
Trait Anxiety
Time frame: From baseline (T0) to 10 weeks after enrollment (T3)
Prolonged Grief Symptoms
Time frame: From baseline (T0) to 10 weeks after enrollment (T3)
Caregiver Strain
Time frame: From baseline (T0) to 10 weeks after enrollment (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Related trials for Caregiver Anxiety
Not yet recruiting
Health-Related Social Needs Food Boxes Delivery Program
Food Insecurity
Not yet recruitingObservational study
Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
Anxiety
Recruiting
A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers
Cancer Patients, Care Givers
Not yet recruitingPhase 2
Peer Support for Family Caregivers of Older Adults Living With Dementia
Caregiver Burden, Caregiver Burnout
Recruiting
CommunityRx-Dementia + Peer Navigation (CRxDpeer)
Alzheimer s Disease, Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahia Hakiki principal investigator
IRCCS Fondazione Don Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver training and administration of SAFE scale and Standard clinical care in people with Caregiver Anxiety and Acquired Brain Injury, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Fanciullacci (+39 3937317440, cfanciullacci@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregivers' Perceived Understanding of Their Relative's Clinical Condition (time frame: 6 weeks from the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.