Trial · NCT07912372
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
NCT07912372, Not applicable, Recruiting, Fondazione Don Carlo Gnocchi ETS
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale. Trials, record NCT07912372. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912372
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
- NCT number
- NCT07912372
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 68 participants, estimated
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Conditions
- Caregiver Anxiety, Acquired Brain Injury, Caregiver Satisfaction and Connectedness to Clinic, Disorders of Consciousness Due to Severe Brain Injury, Therapeutic Alliance
- Interventions
- Caregiver training and administration of SAFE scale, Standard clinical care
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Caregivers' Perceived Understanding of Their Relative's Clinical Condition | 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). |
| Secondary | Family Satisfaction with Care | 10 weeks from the enrollment (T3) | 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). |
| Secondary | Decisional Conflict | 10 weeks after enrollment (T3) | 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). |
| Secondary | Depressive Symptoms | From baseline (T0) to 10 weeks after enrollment (T3) | 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). |
| Secondary | State Anxiety | From baseline (T0) to 10 weeks after enrollment (T3) | 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). |
| Secondary | Trait Anxiety | From baseline (T0) to 10 weeks after enrollment (T3) | 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). |
| Secondary | Prolonged Grief Symptoms | From baseline (T0) to 10 weeks after enrollment (T3) | 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). |
| Secondary | Caregiver Strain | From baseline (T0) to 10 weeks after enrollment (T3) | 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). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07912372
GET https://conductscience.org/api/trials/v1/NCT07912372/registered