Parkinson DiseaseNCT05209698
Self-Management Behaviors of Arabs and Jews With Parkinson's Disease and Their Associations With Health Outcomes
An observational study of Parkinson Disease and Neuro-Degenerative Disease, run by University of Haifa at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Neuro-Degenerative Disease, Movement Disorders
- How many people
- 2,500 participants
- Where
- 1 siteIsrael
- Study dates
- 15 May 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of PD.
- 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).
Who cannot join
- Acute hospitalization in the last 3 months.
- Severe co-morbidities other than PD that affect daily living, special populations including pregnant women, minors (<18 years old).
- Patients who are not eligible to sign consent forms due to physical or mental conditions.
- People who have a guardian, score less than 20 in the Mini-Mental state exam test.
Trial locations and contacts
1 site in 1 country.
Galit Yogev-Seligman, PhD contact
Israel1 site, 1 recruiting
- Recruiting
University of Haifa
Haifa, Aba Hushi, 3498838
Michal Kafri, PhD, 97248249461, kafri.michal@gmail.com
Galit Yogev-Seligmann, PhD, 97248249973, galit.yogev@gmail.com
About this study
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.
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.
Read the 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.
- Keywords
- Self-management, Patient activation, Parkinson's disease
- Medical subject headings
- Parkinson Disease, Movement Disorders, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Visits to a neurologist
extraction and analysis of data from Clalit's electronic medical records (EMR) of 2500 patients with Parkinson's Disease
Measured: 1 year
Use of physical therapy services
extraction and analysis of data from Clalit's electronic medical records (EMR) of 2500 patients with Parkinson's Disease
Measured: 1 year
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).
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start15 May 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Responsible party
- Sponsor
- Investigators
- Michal Kafri, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209698
- Sponsor's protocol ID
- 0128-19-COM1
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2022
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Naamneh-Abuelhija B, Kafri M, Kestenbaum M, Giveon S, Kamah S, Shved S, Yogev-Seligmann G. Concealment of Parkinsons disease prevalence and impact on health and quality of life. Sci Rep. 2025 Mar 4;15(1):7551. doi: 10.1038/s41598-025-91579-8.
PubMed 40038366Naamneh-Abuelhija B, Kafri M, Kestenbaum M, Shadmi E, Mintz I, Shved S, Giveon S, Kamah S, Yogev-Seligmann G. Utilization of Neurology and Allied Health Services by People With Parkinson's Disease in Israel: A Retrospective Observational Study. J Neurol Phys Ther. 2025 Oct 1;49(4):183-191. doi: 10.1097/NPT.0000000000000502. Epub 2025 Sep 16.
PubMed 39601514
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05209698
- Acronym / sponsor ID
- 0128-19-COM1
- Keywords
- Self-management, Patient activation, Parkinson's disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of PD.
- 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).
Key exclusion criteria (4 listed)
- Acute hospitalization in the last 3 months.
- Severe co-morbidities other than PD that affect daily living, special populations including pregnant women, minors (<18 years old).
- Patients who are not eligible to sign consent forms due to physical or mental conditions.
- People who have a guardian, score less than 20 in the Mini-Mental state exam test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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).
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Derived from this study: PubMed 40038366Naamneh-Abuelhija B, Kafri M, Kestenbaum M, Giveon S, Kamah S, Shved S, Yogev-Seligmann G. Concealment of Parkinsons disease prevalence and impact on health and quality of life. Sci Rep. 2025 Mar 4;15(1):7551. doi: 10.1038/s41598-025-91579-8.
- Derived from this study: PubMed 39601514Naamneh-Abuelhija B, Kafri M, Kestenbaum M, Shadmi E, Mintz I, Shved S, Giveon S, Kamah S, Yogev-Seligmann G. Utilization of Neurology and Allied Health Services by People With Parkinson's Disease in Israel: A Retrospective Observational Study. J Neurol Phys Ther. 2025 Oct 1;49(4):183-191. doi: 10.1097/NPT.0000000000000502. Epub 2025 Sep 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galit Yogev-Seligman, PhD contact
Michal Kafri, PhD principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Neuro-Degenerative Disease, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Kafri, PhD (97248249461, kafri.michal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visits to a neurologist (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.