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Consequences of the COVID-19 Lockdown on Health and Well-being of Patients With Parkinson Disease and Post-stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04535297
Recruitment Status : Completed
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Galit Yogev-Seligmann, University of Haifa

Study Description
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Brief Summary:
The study aimed at describing the effects of the COVID-19 social distancing on function, health and well-being of patients with Parkinson's disease or post-stroke, and test the association between the patient activation level and these effects.An anonymous survey was distributed through social media and patient associations.Community-living patients with Parkinson's disease or post-stroke were invited to answer the survey.

Condition or disease Intervention/treatment
Parkinson Disease Stroke Other: exposure

Detailed Description:

People with chronic diseases like Parkinson's disease or post-stroke rely on routine medical and rehabilitative care to maintain daily function and health. These are important aspects of self-management. However, this was challenged by the social distancing due to COVID-19, which limited participation in regular routines.

The study objectives were: To (1) describe the effects of the COVID-19 social distancing on function, health and well-being of patients with Parkinson's disease or post-stroke, and (2) test the association between the patient activation level and these effects.

Community-living patients with Parkinson's disease or post-stroke were invited to answer an anonymous survey through social media and patient associations. Part 1 included 27 multiple-choice questions regarding current status and changes in function, health, medical care and well-being. Part 2 consisted of the Patient Activation Measure, describing people's knowledge, skill, and confidence in managing their own health.

Study Design
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Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Consequences of the COVID-19 Lockdown on Health and Well-being of Patients With Parkinson Disease and Post-stroke
Actual Study Start Date : May 10, 2020
Actual Primary Completion Date : May 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: exposure
    Exposure to social distancing due to COVID-19

Outcome Measures
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Primary Outcome Measures :
  1. Patient Activation Measure (PAM®) [ Time Frame: 1 hour ]
    The PAM is a self-reported validated, licensed tool to measure a patient's knowledge, skills and confidence for self-management. The overall score captures the extent to which people feel engaged and confident in taking care of their health condition. It consists of 13 statements rated on a Likert scale according to agreement. Scores are divided into 4 levels, where 1 represents patients who tend to be passive and feel overwhelmed managing their own health, and 4 represents patients who have effectively adopted self-management behaviors. We used a validated licensed Hebrew and version of the PAM supplied by Insignia Health (https://www.insigniahealth.com/products/pam-survey), which holds the copyright to the questionnaire.

  2. Answers to multiple-choice questions [ Time Frame: 1 hour ]
    participants were asked to answer 27 multiple-choice questions regarding status and change in status of mobility, mood (depression, anxiety), tiredness, social support, body weight, physical activity, rehabilitative treatments and disease symptoms


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with PD or their caregivers, or patients post-stroke or their caregivers
Criteria

Inclusion Criteria:

  • People diagnosed with Parkinson's disease or their caregivers, or people post-stroke or their caregivers
  • Live in the community
  • If a family member or caregiver completed the survey, we asked them to answer in reference to the patient.

Exclusion Criteria:

  • diagnosis of COVID-19
  • hospitalization in the last 3 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535297


Locations
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Israel
Galit Yogev-Seligmann
Haifa, Please Select..., Israel, 3498838
Sponsors and Collaborators
University of Haifa
Investigators
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Principal Investigator: Galit Yogev-Seligmann University of Haifa
More Information
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Responsible Party: Galit Yogev-Seligmann, Dr., University of Haifa
ClinicalTrials.gov Identifier: NCT04535297    
Other Study ID Numbers: 203/20
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Parkinson Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases