NCT07903298 Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
| NCT ID | NCT07903298 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Neuro-Degenerative Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2028-08-15 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-09-15 with a primary completion date of 2028-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects of Italian nationality over 18 years of age; 2. Being a caregiver/family member of a patient with a neuromotor disease; 3. Signing the Informed Consent and agreeing to participate in all study procedures. Exclusion Criteria: 1. Caregivers over 80 years of age; 2. History of cognitive/psychiatric deficits that may compromise the ability to provide help and/or understand the administered questionnaires.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07903298 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Neuro-Degenerative Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07903298 currently recruiting?
Yes, NCT07903298 is actively recruiting participants. Contact the research team at marina.manera@icsmaugeri.it for enrollment information.
Where is the NCT07903298 trial being conducted?
This trial is being conducted at Sciacca, Italy, Bari, Italy, Telese Terme, Italy, Lumezzane, Italy and 9 additional locations.
Who is sponsoring the NCT07903298 clinical trial?
NCT07903298 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 300 participants.