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

Parkinson Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209698
• Other study ID #: 0128-19-COM1
• Status: Recruiting
• Start date: May 15, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2022
• Source: University of Haifa
• Contact: Michal Kafri, PhD
• Phone: 97248249461
• Email: kafri.michal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Movement Disorders
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Parkinson Disease

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa	Aba Hushi

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visits to a neurologist	extraction and analysis of data from Clalit's electronic medical records (EMR) of 2500 patients with Parkinson's Disease	1 year
Primary	Use of physical therapy services	extraction and analysis of data from Clalit's electronic medical records (EMR) of 2500 patients with Parkinson's Disease	1 year
Primary	Patient's Activation Measure (PAM-13®, Insignia Health)	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
Primary	International Physical Activity Questionnaire- IPAQ-SHORT	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
Primary	Parkinson's Disease Questionnaire-39 (PDQ-39)	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
Primary	Nottingham Extended Activities of Daily Living (NEADL)	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