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OpenTrials
Completed

NCT Number: NCT04535297

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Galit Yogev-Seligmann

Haifa, Please Select..., 3498838, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure

Other

Exposure to social distancing due to COVID-19

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2020
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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