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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05211700
Recruitment Status : Completed
First Posted : January 27, 2022
Last Update Posted : May 11, 2023
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by (Responsible Party):
Galit Yogev-Seligmann, University of Haifa

Brief 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

Condition or disease Intervention/treatment
Parkinson Disease Other: This is an observational study, there is no intervention in this study.

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Socio-Clinical Factors Associated With Self-Management and Patient Activation in Parkinson's Disease
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : March 28, 2022
Actual Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: This is an observational study, there is no intervention in this study.
    There is no intervention in this study


Primary Outcome Measures :
  1. Patient's Activation Measure (PAM-13®️, Insignia Health) [ Time Frame: through study completion, an average of 1 year ]

    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)


  2. International Physical Activity Questionnaire- IPAQ-SHORT [ Time Frame: through study completion, an average of 1 year ]
    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.

  3. Utilization of rehabilitative treatments [ Time Frame: Through study completion, an average of 1 year ]
    Participants reported about whether and how frequently they utilize physical therapy, occupational therapy, and speech and language pathology treatments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • Diagnosis of PD
  • Age > 18

Exclusion Criteria:

• Mini Mental State Exam<20


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05211700


Locations
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Israel
Galit Yogev-Seligmann
Haifa, Please Select..., Israel, 3498838
Sponsors and Collaborators
University of Haifa
Rambam Health Care Campus
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Responsible Party: Galit Yogev-Seligmann, Prinicipal Investigator, University of Haifa
ClinicalTrials.gov Identifier: NCT05211700    
Other Study ID Numbers: 0067-19-RMB
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases