Status of People With Cerebral Palsy and Their Caregivers During COVID-19 Pandemic

NCT04753632 | Unknown

• 1 other identifier: DF0095UG
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (9)

• Questionnaire of Knowledge, attitudes and practice towards COVID-19

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

  Baseline

• Caregiver COVID-19 limitation scale

  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.

  Baseline

• Fear of Coronavirus-19 Scale

  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.

  Baseline

• Covid-19 Stress Scale (CSS)

  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.

  Baseline

• Coronavirus Anxiety Scale (CAS)

  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.

  Baseline

• Connor-Davidson Resilience Scale-10

  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)

  Baseline

• COPE

  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

  Baseline

• Medical Outcomes Study-Social Support Survey

  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.

  Baseline

• Zarit Burden Inventory

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

  Baseline

Secondary Outcomes (7)

• Euroqol-5D

  Baseline

• Hospital Anxiety and Depression Scale

  Baseline

• Pittsburgh Sleep Quality Index

  Baseline

• International Physical Activity Questionnaire

  Baseline

• Functional independence measure

  Baseline

Study Arms (2)

Cerebral palsy patients and caregivers

Cerebral palsy patients and caregivers

Healthy people and their caregivers

Healthy people and their caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cerebral palsy patients and their caregivers

You may qualify if:

• Cerebral palsy patients and their caregivers

You may not qualify if:

• Patients or caregivers with Cognitive impairment

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Department of Physical Therapy

Granada, 18016, Spain

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; PT; PhD

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 15, 2021
• Study Start: March 9, 2021
• Primary Completion: May 15, 2021
• Study Completion: June 15, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)