Neuro-Degenerative DiseasesNCT07903298
Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
A study testing QBI questionnaires in people with Neuro-Degenerative Diseases and Care Givers, run by Istituti Clinici Scientifici Maugeri SpA at 13 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuro-Degenerative Diseases, Care Givers, Ictus
- What is being tested?
- QBI questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 13 sitesItaly
- Study dates
- 15 Sep 2025to 31 Dec 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects of Italian nationality over 18 years of age;
- Being a caregiver/family member of a patient with a neuromotor disease;
- Signing the Informed Consent and agreeing to participate in all study procedures.
Who cannot join
- Caregivers over 80 years of age;
- History of cognitive/psychiatric deficits that may compromise the ability to provide help and/or understand the administered questionnaires.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Italy13 sites, 13 recruiting
- Recruiting
ICS Maugeri IRCCS
Bari, BA, 70124
Simona Spaccavento, +39-080-7814111, simona.spaccavento@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS
Castel Goffredo, Mantova, 46042
Chiara Forlani, +39-0376-77471, chiara.forlani@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS, Psychology Unit
Genova
Marcella Ottonello, PsyD, +39-010-307911, marcella.ottonello@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS
Lumezzane, Brescia, 25065
Lidia Gazzi, +39-030--8253011, lidia.gazzi@icsmaugeri.it
- Recruiting
ICS Maugeri
Marina di Ginosa, Taranto, 74025
Marzia Rosaria Tritto, +39-099-8279600, marziarosaria.tritto@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS
Milan, 20138
Davide Sattin, +39-02-705259, davide.sattin@icsmaugeri.it
- Recruiting
ICS Maugeri
Mistretta, Messina, 98073
Luisa Scaduto, +39-0921389111, luisa.scaduto@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS
Montescano, Pavia
Valeria Torlaschi, +39-0385-2471, valeria.torlaschi@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS, Psychology Unit
Pavia, 27100
Marina R Manera, PsyD, +39-0382-592952, marina.manera@icsmageri.it
- Recruiting
ICS Maugeri IRCCS
Sciacca, Agrigento, 92019
Stefania Ruvolo, +39-0925-962111, stefania.ruvolo@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS
Telese Terme, Benevento
Pasquale Moretta, +39-0824-909258, pasquale.moretta@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS
Tradate, Varese, 21049
Giorgio Ferriero, +39-0331-829111, giorgio.ferriero@icsmaugeri.it
- Recruiting
ICS Maugeri IRCCS
Veruno, Novara, 28013
Giusi Figliano, +39-0322-884711, giusi.figliano@icsmaugeri.it
About this study
Official title: Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the Informational Needs Questionnaire (QBI-R/V).
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.
Read the detailed description
| 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).
- Being tested
- QBI questionnaires
- Keywords
- care givers, neurorehabilitation
- Medical subject headings
- Brain Injuries, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBI questionnairesOther
Also called QBI-R, QBI-V
A new questionnaire on care givers needs that will be validated.against the CNA and SAT-16 questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| QBI | Experimental | The QBI questionnaire will be administered to care givers at the time of patients hospitalisation and after discharge. Receives: Other: QBI questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the rehabilitation period (2-6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Sep 2025
- Primary completion15 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-Degenerative DiseasesStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Family members of patients hospitalized at the Neurorehabilitation Units of the participating ICS Maugeri SPA SB Institutes will be recruited and administered the relevant questionnaires both at beginning and at the end of the study.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903298
- Sponsor's protocol ID
- 0045839/25 CET6
- Other IDs
- QBI
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the Informational Needs Questionnaire (QBI-R/V).
- ClinicalTrials.gov ID
- NCT07903298
- Acronym / sponsor ID
- 0045839/25 CET6
- Keywords
- care givers, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Oct 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.
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.
Detailed description
| 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Family members of patients hospitalized at the Neurorehabilitation Units of the participating ICS Maugeri SPA SB Institutes will be recruited and administered the relevant questionnaires both at beginning and at the end of the study.
| Arm | Type | Receives |
|---|---|---|
| QBI | Experimental | Other: QBI questionnairesThe QBI questionnaire will be administered to care givers at the time of patients hospitalisation and after discharge. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects of Italian nationality over 18 years of age;
- Being a caregiver/family member of a patient with a neuromotor disease;
- Signing the Informed Consent and agreeing to participate in all study procedures.
Key exclusion criteria (2 listed)
- Caregivers over 80 years of age;
- History of cognitive/psychiatric deficits that may compromise the ability to provide help and/or understand the administered questionnaires.
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 |
|---|---|---|
| QBI questionnairesAlso: QBI-R, QBI-VA new questionnaire on care givers needs that will be validated.against the CNA and SAT-16 questionnaires. | Other | QBI |
Primary outcome
Validation of the QBI questionnaire
Time frame: From enrollment to the end of the rehabilitation period (2-6 months).
Creation of a reliable and valid tool for detecting the informational needs of caregivers of neurological patients during rehabilitation hospitalization.
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 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Neuro-Degenerative Diseases
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingPhase 2
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
Langerhan's Cell Histiocytosis, Juvenile Xanthogranuloma
Enrolling by invitationObservational study
Białystok PLUS - Polish Longitudinal University Study
Cardiovascular Diseases, Diabetes
Not yet recruitingPhase 1/2
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy
Multiple Sclerosis, Primary Progressive Multiple Sclerosis
Active, not recruiting
Eccentric Cycling in Multiple Sclerosis Rehabilitation
Multiple Sclerosis, Rehabilitation
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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QBI questionnaires in people with Neuro-Degenerative Diseases and Care Givers, run by Istituti Clinici Scientifici Maugeri SpA at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 Marina R Manera, PsyD (+39-0382-592952, marina.manera@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the QBI questionnaire (time frame: From enrollment to the end of the rehabilitation period (2-6 months).). 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 29 Oct 2026.