NCT04535297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

20 days

First QC Date

August 31, 2020

Last Update Submit

August 31, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

Exposure to social distancing due to COVID-19

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galit Yogev-Seligmann

Haifa, Please Select..., 3498838, Israel

Location

MeSH Terms

Conditions

Parkinson DiseaseStroke

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Galit Yogev-Seligmann

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 1, 2020

Study Start

May 10, 2020

Primary Completion

May 30, 2020

Study Completion

June 30, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations