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CompletedNCT04535297Updated Sep 1, 2020

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

An observational study in Parkinson Disease and Stroke, sponsored by University of Haifa. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-01.

Sponsored by University of Haifa · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
198
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Stroke
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 198 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Haifa is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with PD or their caregivers, or patients post-stroke or their caregivers

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

Exclusion Criteria:

  • diagnosis of COVID-19
  • hospitalization in the last 3 months.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
198 participants (actual)
Patient registry
No

Interventions

  • Otherexposure

    Exposure to social distancing due to COVID-19

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

  2. 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

    Time frame: 1 hour

07

Study locations

1 site
  • Galit Yogev-Seligmann
    Haifa, Please Select... 3498838, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04535297
Lead sponsor
University of Haifa
Responsible party
Galit Yogev-Seligmann (Dr., University of Haifa) — Principal investigator
First posted
Sep 1, 2020
Start date
May 10, 2020
Primary completion
May 30, 2020
Completion
Jun 30, 2020
Last update
Sep 1, 2020

Study contacts

Galit Yogev-Seligmann
principal investigator · University of Haifa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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