An interventional study of QBI questionnaires in Neuro-Degenerative Diseases, Care Givers and Ictus, sponsored by Istituti Clinici Scientifici Maugeri SpA. Recruiting at 13 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Supportive care
Background and rationale. Although the literature suggests that caregivers have different needs at various stages of the patient's illness, to date, most studies have focused only on the needs of caregivers of patients with specific diseases or during specific periods of the illness trajectory, and have not explored changes in caregivers' needs throughout the entire neuromotor recovery process, from admission to discharge in rehabilitation wards. In a patient-centered care perspective, it is important not only to explore the informal experiences of patients and caregivers regarding outcomes and consequences of the transition from hospital to home, but also their perspectives on interventions that would support them in self-management. In this context, this study represents the next phase of a qualitative study that identified the underlying dimensions of caregivers' informational needs, essential for constructing a measurement tool that allows both qualitative and quantitative assessment of these needs. The tool would make it possible to identify, upon patient admission to rehabilitation, the essential informational needs in order to address them during hospitalization. The same items would also serve to assess the response obtained, in terms of healthcare service quality, before discharge.
Study design. Experimental with low level of intervention. Objectives. The study aims to validate a questionnaire specifically developed to detect and assess the informational needs of caregivers of neurological patients during rehabilitation hospitalization (post-acute phase).
Endpoint. Creation of a reliable and valid tool for detecting the informational needs of caregivers of neurological patients during rehabilitation hospitalization.
\| Sample Size \| The quality of validation studies requires the enrollment of about 4-10 patients per questionnaire item, with a minimum of 100 subjects to ensure the stability of the variance-covariance matrix. Based on this, for our study, administration to about 300 caregivers (about 25 subjects for each of the 13 participating centers) is considered adequate, assuming a data loss and/or compilation error rate of about 15%. Thus, the final sample available for analysis is about 255 subjects for the detection of needs and the study of the questionnaire's reliability and validity. \| \| Study Duration \| 3 years \| \| Study Phases \| 1) Recruitment of family members of patients hospitalized in the Neurorehabilitation Units of the participating ICS Maugeri SPA SB Institutes. (Patients with neurological diseases, recruited within 10 days from the start of hospitalization. Recruitment will take place directly in the wards, through verbal request and after explaining the purposes, halfway through the hospitalization period.) 2) Upon patient admission to the ward and in any case within the first 10 days of admission, administration of the Informational Needs Detection Questionnaire (QBI-R). 3) At patient discharge (within 7 days from the discharge date), the Informational Needs Assessment Questionnaire (QBI-V) will be provided to assess the degree of satisfaction with which informational needs have been met. \| \| Statistical Methods \| A descriptive analysis of the data collected through the questionnaires will be performed, as well as a validation study of the questionnaire. The measures derived from the questionnaires will be summarized with the mean and standard deviation or, where more appropriate, by the median and interquartile range. The factorial structure of the questionnaire will be explored, and internal consistency will be assessed by calculating item-total correlations and Cronbach's alpha coefficient. Test-retest reliability will be tested on a reduced sample of caregivers (50 subjects) evaluated at T0 and T1 using Spearman's non-parametric correlation coefficients. Furthermore, the reproducibility of the total and scale scores will be tested using intraclass correlation coefficients (ICC). Concurrent validity of the scale will also be assessed by comparison with the CNA for the QBI-R part and with the SAT-16 for the QBI-V. Finally, FSQ scores will be correlated with measures of anxiety, depression, and caregiver burden. Statistical analyses will be conducted using the Stata 11 statistical package (STATA Corp. LLC).
2,127 studies on the registry are indexed under Brain Injuries; 386 are open to participants now.
This study's planned enrollment of 300 is above the median of 48 across 1,343 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 125 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
The QBI questionnaire will be administered to care givers at the time of patients hospitalisation and after discharge.
Other: QBI questionnaires
A new questionnaire on care givers needs that will be validated.against the CNA and SAT-16 questionnaires.
Also known as: QBI-R, QBI-V
Validation of the QBI questionnaire
Creation of a reliable and valid tool for detecting the informational needs of caregivers of neurological patients during rehabilitation hospitalization.
Time frame: From enrollment to the end of the rehabilitation period (2-6 months).
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Aug 2028, 35 months after the start.
Of 570 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's planned 35 months is close to that.
Counting every sponsor, half of 603 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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