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Self-Management Behaviors of Arabs and Jews With Parkinson's Disease and Their Associations With Health Outcomes

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ClinicalTrials.gov Identifier: NCT05209698
Recruitment Status : Recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
University of Haifa

Study Description
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Brief Summary:

The study will examine the reciprocal relationships between the community, healthcare system, and personal determinants of self-management behaviors in persons with Parkinson's disease and their association with the performance of these behaviors in persons with Parkinson's Disease.

In the first part of the study, data will be extracted from electronic medical records of 2500. In the second part of the study, a sub-sample of 200 participants with Parkinson's disease will be asked to answer standardized questionnaires.


Condition or disease
Parkinson Disease Neuro-Degenerative Disease Movement Disorders

Detailed Description:

Parkinson's disease is a chronic, protracted condition. Its diverse symptoms affect the daily functioning and quality of life of patients and their families. The progressive disability is accompanied by medical complications and hospitalizations, which increase the economic burden on patients and healthcare systems. Factors that can mitigate these adverse consequences include care from a neurologist, rehabilitative treatments, and patients' use of self-management strategies. However, studies suggest that Patients with Parkinson from minority groups are less likely to be treated by a neurologist. Also, it is unclear whether Patients with Parkinson from minority groups are offered self-management strategies.

The study objectives were: To (1) to identify the reciprocal relationships among extra- and intra-personal level determinants of Self-Management Behaviors and their association with performance of these behaviors in persons with Parkinson's Disease, (2) identify the relationships between self-management behaviors (medical and lifestyle), function, and quality of life in patients with Parkinson's Disease.

Phase A of the study is a retrospective study based on extraction and analysis of data from electronic medical records, and phase B of the study is a cross-sectional study based on face-to-face meetings with a subsample of the patients whose data are included in the retrospective study.

Study Design
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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Health Outcomes in Patients With Parkinson's Disease in Israel: Associations With Accessibility, Utilization of Healthcare Services and Patients' Attitudes Among Different Ethnic Groups.
Actual Study Start Date : May 15, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Ethnic groups- Jews and Arabs
Data will be extracted from electronic medical records for all people with PD residing in a specific HMO district according to a record-based survey (e.g., individuals whose medical records include a diagnosis of PD). Currently, there are 2500 patients with PD in that district. In the second part of the study, a sub-sample of 100 Jewish and 100 Arab Patients with Parkinson's disease will be asked to answer standardized questionnaires.


Outcome Measures
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Primary Outcome Measures :
  1. Visits to a neurologist [ Time Frame: 1 year ]
    extraction and analysis of data from Clalit's electronic medical records (EMR) of 2500 patients with Parkinson's Disease

  2. Use of physical therapy services [ Time Frame: 1 year ]
    extraction and analysis of data from Clalit's electronic medical records (EMR) of 2500 patients with Parkinson's Disease

  3. Patient's Activation Measure (PAM-13®, Insignia Health) [ Time Frame: 1 hour ]

    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).


  4. International Physical Activity Questionnaire- IPAQ-SHORT [ Time Frame: 1 hour ]
    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.

  5. Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: 1 hour ]
    This 39-item questionnaire is a patient-reported measure of health status and quality of life. It assesses how often people affected by PD experience difficulties across 8 dimensions of daily living, including relationships, social situations and communication. It also assesses the impact of Parkinson's on specific dimensions of functioning and wellbeing.

  6. Nottingham Extended Activities of Daily Living (NEADL) [ Time Frame: 1 hour ]
    The NEADL is a patient-reported outcome measure that consists of 22 items of everyday activities. It assesses patients' independence in activities of daily living.


Eligibility Criteria
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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 within a distinct district of an HMO company have Parkinson's disease.

Currently, there are 2,500 Patients with Parkinson's Disease in that district, of whom 281 are members of the Arab society.

Criteria

Inclusion Criteria for the retrospective study: People diagnosed with Parkinson's Disease.

Exclusion Criteria: None.

Inclusion Criteria for the cross-sectional study:

  1. Diagnosis of PD.
  2. Jewish sector will be fluency in Hebrew (comprehension, speaking, and reading), and for the Arab sector, fluency in Arabic or Hebrew (comprehension, speaking, and reading).

Exclusion Criteria for the cross-sectional study:

  1. Acute hospitalization in the last 3 months.
  2. Severe co-morbidities other than PD that affect daily living, special populations including pregnant women, minors (<18 years old).
  3. Patients who are not eligible to sign consent forms due to physical or mental conditions.
  4. People who have a guardian, score less than 20 in the Mini-Mental state exam test.
Contacts and Locations
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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): NCT05209698


Contacts
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Contact: Michal Kafri, PhD 97248249461 kafri.michal@gmail.com
Contact: Galit Yogev-Seligman, PhD galit.yogev@gmail.com

Locations
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Israel
University of Haifa Recruiting
Haifa, Aba Hushi, Israel, 3498838
Contact: Michal Kafri, PhD    97248249461    kafri.michal@gmail.com   
Contact: Galit Yogev-Seligmann, PhD    97248249973    galit.yogev@gmail.com   
Principal Investigator: Michal Kafri, PhD         
Principal Investigator: Galit Yogev, PhD         
Sub-Investigator: Badera Naamneh-Abuelhija, PhD student         
Sponsors and Collaborators
University of Haifa
Clalit Health Services
Investigators
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Principal Investigator: Michal Kafri, PhD University of Haifa
More Information
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Responsible Party: University of Haifa
ClinicalTrials.gov Identifier: NCT05209698    
Other Study ID Numbers: 0128-19-COM1
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Haifa:
Self-management
Patient activation
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Movement Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Synucleinopathies