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临床试验/NCT04753632
NCT04753632Unknown不适用

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

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Questionnaire of Knowledge, attitudes and practice towards COVID-19

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cerebral palsy patients and their caregivers

排除标准

  • Patients or caregivers with Cognitive impairment

结局指标

主要结局

Questionnaire of Knowledge, attitudes and practice towards COVID-19

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Baseline

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Carmen Valenza

Principal Investigator; PT; PhD

Universidad de Granada

研究点 (1)

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