NCT05209698

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

January 23, 2022

Last Update Submit

January 23, 2022

Conditions

Keywords

Self-managementPatient activationParkinson's disease

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, Aba Hushi, 3498838, Israel

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Parkinson DiseaseMovement DisordersPatient Participation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Michal Kafri, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Kafri, PhD

CONTACT

Galit Yogev-Seligman, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2022

First Posted

January 26, 2022

Study Start

May 15, 2021

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations