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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535297
• Other study ID #: 203/20
• Status: Completed
• Start date: May 10, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Stroke

Intervention

Other:
• exposure
Exposure to social distancing due to COVID-19

Locations

Country	Name	City	State
Israel	Galit Yogev-Seligmann	Haifa	Please Select...

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Activation Measure (PAM®)	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.	1 hour
Primary	Answers to multiple-choice questions	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	1 hour