Clinical trial NCT05209698: Self-Management Behaviors of Arabs and Jews With Parkinson's Disease and Their Associations With Health Outcomes
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Neuro-Degenerative Disease
Movement Disorders
Keywords: Self-management
Patient activation
Parkinson's disease
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2022-01-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Visits to a neurologist
timeFrame: 1 year
measure: Use of physical therapy services
timeFrame: 1 year
measure: Patient's Activation Measure (PAM-13®, Insignia Health)
timeFrame: 1 hour
measure: International Physical Activity Questionnaire- IPAQ-SHORT
timeFrame: 1 hour
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: 1 hour
measure: Nottingham Extended Activities of Daily Living (NEADL)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
state: Aba Hushi
Study officials:
affiliation: University of Haifa
name: Michal Kafri, PhD
role: PRINCIPAL_INVESTIGATOR
References: