Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy
Experiences, Outcomes and Unmet Needs of Caregivers of Children With Cerebral Palsy in Spain: A Mixed-Method Study
Study Overview
Status
Conditions
Detailed Description
Before the recruitment begins, the principal investigator will present the project to the pediatric service of the Arnau de Vilanova University Hospital of Lleida (HUAV). During medical consultations, the pediatric service will inform eligible participants about the study. If the caregiver agrees to participate, they will give consent for the pediatric service to share their contact details with the research team. The investigators will then contact the participant to explain the project in detail, schedule a first meeting to sign the Informed Consent, and complete the initial questionnaires. The Informed Consent will include the first author's contact information so that participants can address any questions or concerns about the study. Additionally, participants who sign the informed consent will be asked to provide their contact information for potential follow-up regarding the qualitative interview.
In the first meeting, participants who meet the inclusion criteria and have signed the informed consent will be directed to a study homepage hosted on the university's website. This website will provide a link to REDCap (Research Electronic Data Capture), a secure platform specifically designed for collecting research data (PedsQL-FIM, ZBI, PSS-14).
Participants' sociodemographic data will include descriptive information such as age, sex, household income, among others
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: CLAUDIA ARUMI, Msc
- Phone Number: +34630004767
- Email: claudia.arumi@udl.cat
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- >18 years old
- Being a caregiver of a child with Cerebral Palsy
- Spanish/Catalan speaking
- Willing to talk about their experiences and be audio/video-recorded.
- Accept and sign the informed consent form
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cerebral Palsy caregivers
Quantitative data will be collected and analysed using three questionnaires, providing the authors with a comprehensive profile of participants' stress levels, quality of life, and caregiver burden.
This data will also enable the identification of specific subgroups that will be the primary focus of the subsequent qualitative phase, while informing the development of new research questions for a deeper exploration during this phase.
Participants who meet the inclusion criteria and have signed the informed consent will be directed to a study homepage hosted on the university's website.
This website will provide a link to REDCap (Research Electronic Data Capture), a secure platform specifically designed for collecting research data (PedsQL-FIM, ZBI, PSS-14).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stress
Time Frame: Day 1
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The PSS-14 is short and easy adaptation of the original Perceived Stress Scale (PSS), with the original author being Cohen, S. The European Spanish adaptation was conducted by Remor, E. The PSS measures the degree to which individuals perceive life situations as stressful over the past month, focusing on subjective control over unpredictable events and the distress associated with perceived lack of control. The PSS is more closely related to subjective evaluations of life events than objective measures of stressors (18). The PSS-14 European Spanish version will be used and consists of 14 items scored from 0 up to 4 (0=never, 1 = rarely 2= sometimes 3= usually 4 =almost always). The total scores on the scale can range from 0 (no stress) to 56 (extreme stress). The European Spanish version PSS (14-item) demonstrated adequate reliability (internal consistency, alpha = .81, and test-retest, r = .73), validity (concurrent), and sensitivity |
Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Quality of Life
Time Frame: Day 1
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To assess the impact of pediatric chronic health conditions on caregivers and the family, the Spanish version of the PedsQL™ Family Impact Module will be used. This module employs a multidimensional parent self-report to evaluate physical, emotional, social, and cognitive functioning, as well as communication and worry. The module can be completed within 5-10 minutes The PedsQL-FIM It is a 36-item with an internal consistency reliability of α = 0.97 (21). It assesses 8 main factors: physical functioning (6 items), emotional functioning (5 items), social functioning (4 items), cognitive functioning (4 items), communication (3 items), worry (5 items), daily activities (3 items) and family relationships (5 items). The answers are given on a 5-point Likert scale (0 = it is never a problem, 4 = it is almost always a problem) and are reversed scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A greater score indicates better functioning. |
Day 1
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Burden
Time Frame: Day 1
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To asses caregiver burden, the Zarit Burden Interview will be used. The Zarit Burden Interview is a widely used self-report instrument for measuring caregiver burden. ZBI assesses caregivers´ perceptions of burden that may inadvertently affect their health, personal, social or financial wellbeing. Caregivers are requested to assess the level of burden they experience while caring for a loved one. Burden is defined as the degree to which a caregiver perceives negative effects on their emotional and physical health, social life, and finances, which may hinder their ability to provide care. Responses vary from "not at all" to "extremely." It consists of 22 items, with the total score calculated by summing the scores of all the indicated items. It is suggested that a score from 0 to 21 means no to mild burden, 21 to 40 indicates mild to moderate burden, 41 to 60 indicates moderate to severe burden, and more than 61 means severe burden. |
Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Francesc Valenzuela, PhD, Universitat de Lleida
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULleida3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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