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

January 23, 2022 updated by: University of Haifa

Health Outcomes in Patients With Parkinson's Disease in Israel: Associations With Accessibility, Utilization of Healthcare Services and Patients' Attitudes Among Different Ethnic Groups.

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
    • Aba Hushi
      • Haifa, Aba Hushi, Israel, 3498838
        • Recruiting
        • University of Haifa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michal Kafri, PhD
        • Principal Investigator:
          • Galit Yogev, PhD
        • Sub-Investigator:
          • Badera Naamneh-Abuelhija, PhD student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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).
1 hour
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.
1 hour
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.
1 hour
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Collaborators

Clalit Health Services

Investigators

  • Principal Investigator: Michal Kafri, PhD, University of Haifa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

January 23, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 23, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0128-19-COM1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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