Cerebral PalsyNCT04521855
The Caregiver's Burden in Cerebral Palsy
An observational study of Cerebral Palsy, run by Tatiana Besse-Hammer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Questionnaire
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Nov 2019to 5 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy subjects, aged 18 to 75, caring for relatives of adults and children with cerebral palsy, with a good understanding of the French language.
Who may be able to join
- Healthy subjects, aged 18 to 75, caring for relatives of adults and children with cerebral palsy, with a good understanding of the French language.
Who cannot join
- Subjects under 18 or over 75, presenting a language barrier (interview guide written in French), subjects with a known history of psychiatric pathologies.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Questionnaire
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaires in French on the quality of life, the burden of caregiving and a screening for depressive symptoms, completed during specific interviews.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Caregivers (family environment or close entourage) for adults and children with cerebral palsy. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and depression scale (HAD)
The HAD scale is an instrument used to screen for anxiety and depressive disorders. An overall score is calculated by adding the responses to the 14 items (varies from 0 to 42) as well as two sub-scores corresponding to the two subscales (ranging from 0 to 21). The higher the scores, the more severe the symptomatology.
Measured: 15 minutes
ISPN (Nottingham Health Profile - NHP)
The Nottingham Health Profile (NHP) is a general patient reported outcome measure which seeks to measure subjective health status. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.
Measured: 15 minutes
Zarit scale
The Zarit scale assesses the burden felt by caregivers. The total score, which is the sum of the scores obtained for each of 22 items, varies from 0 to 88. A lower score or equal to 20 indicates little or no charge; a score between 21 and 40 indicates a light load; a score between 41 and 60 indicate a moderate load; a score above 60 indicates a severe load.
Measured: 15 minutes
SF12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. A high score corresponds to a better state of health.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start29 Nov 2019
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatiana Besse-Hammer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Costanza Lombardo, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521855
- Sponsor's protocol ID
- CHUB-Lombardo
- Status last verified
- Oct 2023
- First submitted
- 18 Aug 2020
- Last updated
- 24 Oct 2023
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Caregiver's Burden in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04521855
- Acronym / sponsor ID
- CHUB-Lombardo
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tatiana Besse-HammerUniversity, hospital or other
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 21 Aug 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: QuestionnaireCaregivers (family environment or close entourage) for adults and children with cerebral palsy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects, aged 18 to 75, caring for relatives of adults and children with cerebral palsy, with a good understanding of the French language.
Key inclusion criteria (1 listed)
- Healthy subjects, aged 18 to 75, caring for relatives of adults and children with cerebral palsy, with a good understanding of the French language.
Key exclusion criteria (1 listed)
- Subjects under 18 or over 75, presenting a language barrier (interview guide written in French), subjects with a known history of psychiatric pathologies.
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 |
|---|---|---|
| QuestionnaireQuestionnaires in French on the quality of life, the burden of caregiving and a screening for depressive symptoms, completed during specific interviews. | Other | Caregivers |
Primary outcome
Hospital Anxiety and depression scale (HAD)
Time frame: 15 minutes
The HAD scale is an instrument used to screen for anxiety and depressive disorders. An overall score is calculated by adding the responses to the 14 items (varies from 0 to 42) as well as two sub-scores corresponding to the two subscales (ranging from 0 to 21). The higher the scores, the more severe the symptomatology.
ISPN (Nottingham Health Profile - NHP)
Time frame: 15 minutes
The Nottingham Health Profile (NHP) is a general patient reported outcome measure which seeks to measure subjective health status. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.
Zarit scale
Time frame: 15 minutes
The Zarit scale assesses the burden felt by caregivers. The total score, which is the sum of the scores obtained for each of 22 items, varies from 0 to 88. A lower score or equal to 20 indicates little or no charge; a score between 21 and 40 indicates a light load; a score between 41 and 60 indicate a moderate load; a score above 60 indicates a severe load.
SF12
Time frame: 15 minutes
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. A high score corresponds to a better state of health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Costanza Lombardo, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Tatiana Besse-Hammer at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and depression scale (HAD) (time frame: 15 minutes). The study lists 4 primary outcomes in all. 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 24 Oct 2023.