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CompletedNCT05211700Updated May 11, 2023

Socio-Clinical Factors Associated With Self-Management in Parkinson's Disease

An observational study in Parkinson Disease, sponsored by University of Haifa. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by University of Haifa · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study summary

Self-management focuses on the behaviors that people with chronic disease use in order to maintain and improve their health and well-being and includes aspects such as medical and lifestyle management. Parkinson's disease (PD) is a chronic, progressive, incurable neurodegenerative disorder that affects motor and non-motor function. Engagement in self-management behaviors and high activation may be effective tools in fighting the long-lasting burden of the disease. The goal of the current study was to explore socio-clinical factors that associate with specific self-management behaviors and patient activation among patients with Parkinson's disease. PwP were recruited from the Movement Disorders Institute, Department of Neurology, Rambam Health Care Campus. Eligible patients were assessed for cognitive status and filled questionnaires regarding socio-clinical factors included age, gender, severity of motor and non -motor symptoms, family and social support. Data about the comorbidities were retrieved from electronic medical records

Read the detailed description

n Parkinson's disease (PD), implementation of self-management strategies together with high patient activation may be an effective tool in fighting the long-lasting burden of the disease, but little is known about its determinant.

The aims of this study, conducted among patients with PD are to (1) test the association between socio-clinical factors that includes age, gender, cognitive status, comorbidities, disease severity (motor and non-motor symptoms) and social support and SMBs including utilization of rehabilitative treatments (an aspect of medical management), physical activity (an aspects of lifestyle management), and patient activation, and (2) to develop predictive model for each of these three aspects of SMB, based on socio-clinical factors that includes age, gender, cognitive status, comorbidities, disease severity (motor and non-motor symptoms) and social support.

A cross-sectional study of 100 patients that attend a Movement Disorder Clinic with PD will be conducted. Participation will include one evaluation session of approximately 90 minutes. Information about socio-clinical characteristics and self-management behaviors will be collected using demographic questionnaires, standard questionnaires and from electronic medical records. Regression model will test the association between sociodemographic characteristics and self-management behaviors and patient activation.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 90 is close to the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease 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.

04

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 who are treated in the Movement Disorders Institute, Department of Neurology, Rambam Health Care Campus.

Inclusion criteria

  • Diagnosis of PD
  • Age > 18

Exclusion criteria

Exclusion Criteria:

  • Mini Mental State Exam\<20
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
90 participants (actual)
Patient registry
No

Interventions

  • OtherThis is an observational study, there is no intervention in this study.

    There is no intervention in this study

06

What researchers measure

Primary outcomes

  1. Patient's Activation Measure (PAM-13®️, Insignia Health)

    Patient Activation Measure (PAM) score. Patient activation' describes the skills, confidence and knowledge a person has in managing her/his own health and health care. It consists of 13 statements rated on a four-point Likert scale of level of agreement. The PAM-13 score is transformed into a 0-100 continuous scale according to a licensed conversion table (Insignia Health)

    Time frame: through study completion, an average of 1 year

  2. International Physical Activity Questionnaire- IPAQ-SHORT

    This questionnaire asks individuals to assess the number of days and amount of time they spent in the last 7 days in four categories: 1) vigorous activity (heavy lifting, aerobics, fast bicycling), 2) moderate activity (light lifting, moderate bicycling), 3) walking (at least 10 minutes), 4) sitting (watching TV, reading). Total physical activity is calculated as the sum of Walking + Moderate + Vigorous metabolic equivalent (MET) minutes/week scores.

    Time frame: through study completion, an average of 1 year

  3. Utilization of rehabilitative treatments

    Participants reported about whether and how frequently they utilize physical therapy, occupational therapy, and speech and language pathology treatments

    Time frame: Through study completion, an average of 1 year

07

Study locations

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

References and documents

Individual participant data

Plan to share: Undecided

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 May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05211700
Lead sponsor
University of Haifa
Collaborators
Rambam Health Care Campus
Responsible party
Galit Yogev-Seligmann (Prinicipal Investigator, University of Haifa) — Principal investigator
First posted
Jan 27, 2022
Start date
May 1, 2019
Primary completion
Mar 28, 2022
Completion
Mar 30, 2022
Last update
May 11, 2023

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 May 2023. You cannot join it, but the record below documents what was studied.

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