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

Sponsor
University of Haifa (Other)
Overall Status
Recruiting
CT.gov ID
NCT05209698
Collaborator
Clalit Health Services (Other)
2,500
1
16.5
151.3

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated 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
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Visits to a neurologist [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 [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) [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 [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) [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) [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 University of Haifa Haifa Aba Hushi Israel 3498838

    Sponsors and Collaborators

    • University of Haifa
    • Clalit Health Services

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Haifa
    ClinicalTrials.gov Identifier:
    NCT05209698
    Other Study ID Numbers:
    • 0128-19-COM1
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Haifa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022