The Caregiver's Burden in Cerebral Palsy

NCT ID: NCT04521855

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-29
• Study Completion Date: 2022-10-05

Brief Summary

Cerebral palsy (CP) results from damage to the developing brain of the fetus or infant. These non-progressive lesions cause a set of permanent movement and posture disorders, responsible for activity limitations. These disorders are often accompanied by sensory, perceptual, cognitive impairments, communication and behavioral disorders, and sometimes epilepsy and/or secondary musculoskeletal problems. It is the leading cause of motor disability in childhood and affects 200 newborns per year in Belgium.

Cerebral palsy affects two to three people in every 1,000 of the world's population. The prevalence, incidence and most common causes have varied over time due to significant changes in obstetric care and pediatric care. In 75% of all cases of cerebral palsy, the lesions occurred before childbirth.

The population of adults diagnosed with cerebral palsy is increasing as the survival rate of children born with a disability increases. This population requires adapted and expert care services for the continuous monitoring and management of their condition. In addition, the development of additional health problems in adulthood increases the need for permanent access to care structures. Adults with CP have a higher rate of chronic health problems (ischemic heart disease) and a deterioration in their functional status. They would also have difficulty having a social and professional life which negatively impacts their quality of life.

A large number of adults with CP cannot access appropriate care or medico-social structures. This results in a significant involvement of caregivers (family environment or close entourage).

The role of caregiver is at the origin of a significant physical and psychological burden, whether for underage patients or adult patients. The study of this burden is well known in certain neurological pathologies (head trauma, multiple sclerosis, brain tumors). In the field of cerebral palsy, a study showed that the primary caregivers of children with CP had higher levels of psychological and physical disorders than the control group studied (caregivers of healthy children).

Currently, there are very few studies assessing the burden of caregivers of adults with cerebral palsy. The objective of this study is to analyze, through various specific questionnaires, the quality of life and the presence of depressive symptoms linked to the burden of caregivers of adults and children with cerebral palsy, taking into account socio-economic and environmental data.

Conditions

Cerebral Palsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Caregivers

Caregivers (family environment or close entourage) for adults and children with cerebral palsy.

Questionnaire

Intervention Type: OTHER

Questionnaires in French on the quality of life, the burden of caregiving and a screening for depressive symptoms, completed during specific interviews.

Interventions

Questionnaire

Questionnaires in French on the quality of life, the burden of caregiving and a screening for depressive symptoms, completed during specific interviews.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy subjects, aged 18 to 75, caring for relatives of adults and children with cerebral palsy, with a good understanding of the French language.

Exclusion Criteria

• Subjects under 18 or over 75, presenting a language barrier (interview guide written in French), subjects with a known history of psychiatric pathologies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tatiana Besse-Hammer

OTHER

Sponsor Role: lead

Responsible Party

Tatiana Besse-Hammer

Head of the clinical trial unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Costanza Lombardo, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

Brugmann University Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CHUB-Lombardo

Identifier Type: -

Identifier Source: org_study_id