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Clinical Trials/NCT04753632
NCT04753632
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Assessment of the Biopsychosocial Status of People With Cerebral Palsy and Related Diseases and Their Caregivers During the COVID-19 Pandemic

Universidad de Granada1 site in 1 country60 target enrollmentMarch 9, 2021
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Universidad de Granada
Enrollment
60
Locations
1
Primary Endpoint
Questionnaire of Knowledge, attitudes and practice towards COVID-19
Last Updated
5 years ago

Overview

Brief Summary

COVID-19, as well as the collateral situations that it entails, has been causing panic, anguish and anxiety that has generated biopsychosocial problems in society affecting not only the physical and social level but also the mental health and well-being.

The main objective of this research project is to assess the biopsychosocial status of people with cerebral palsy and related diseases and their caregivers during the COVID-19 pandemic.

Registry
clinicaltrials.gov
Start Date
March 9, 2021
End Date
June 15, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

Principal Investigator; PT; PhD

Universidad de Granada

Eligibility Criteria

Inclusion Criteria

  • Cerebral palsy patients and their caregivers

Exclusion Criteria

  • Patients or caregivers with Cognitive impairment

Outcomes

Primary Outcomes

Questionnaire of Knowledge, attitudes and practice towards COVID-19

Time Frame: Baseline

Questionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.

Caregiver COVID-19 limitation scale

Time Frame: Baseline

This scale is used to examine the impact of the COVID-19 pandemic on caregivers. Scores ranged from 1 to 10, and a higher score indicates more limitations.

Fear of Coronavirus-19 Scale

Time Frame: Baseline

It is a scale that assesses the fear of COVID-19. It consists of 7 items scored on a 5-item Likert scale. The higher the score, the more fear.

Covid-19 Stress Scale (CSS)

Time Frame: Baseline

COVID stress scale (CSS): is a 36-item COVID Stress Scale (CSS) to measure these features, as they pertain to COVID-19. The CSS were developed to better understand and assess COVID-19-related distress. The scales were intentionally designed so they could be readily adapted for future pandemics.

Coronavirus Anxiety Scale (CAS)

Time Frame: Baseline

Coronavirus anxiety scale (CAS): It is a scale that measures the anxiety generated by COVID-19 in the last two weeks. It presents 5 items and a score\> 9 indicates dysfunctional anxiety associated with the pandemic.

Connor-Davidson Resilience Scale-10

Time Frame: Baseline

Connor-Davidson Resilience Scale (CD-RISC) was used to measure resilience. Respondents are asked to answer on a five-point Likert scale (0 = totally disagree to 4 = totally agree)

COPE

Time Frame: Baseline

The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimize distress associated with negative life experiences

Medical Outcomes Study-Social Support Survey

Time Frame: Baseline

This brief, self-administered Social Support Survey instrument was developed for patients in the Medical Outcomes Study (MOS), a two-year study of patients with chronic conditions. Higher puntuations indicate higher social support.

Zarit Burden Inventory

Time Frame: Baseline

The Zarit Burden Inventory examines burden associated with functional/behavioural impairments and the home care situation. Higher puntuations indicate higher burden.

Secondary Outcomes

  • Euroqol-5D(Baseline)
  • Hospital Anxiety and Depression Scale(Baseline)
  • Pittsburgh Sleep Quality Index(Baseline)
  • International Physical Activity Questionnaire(Baseline)
  • Functional independence measure(Baseline)
  • Gross motor function classification system(Baseline)
  • Manual Agility Classification System(Baseline)

Study Sites (1)

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