NCT05211700

Brief Summary

Self-management focuses on the behaviors that people with chronic disease use in order to maintain and improve their health and well-being and includes aspects such as medical and lifestyle management. Parkinson's disease (PD) is a chronic, progressive, incurable neurodegenerative disorder that affects motor and non-motor function. Engagement in self-management behaviors and high activation may be effective tools in fighting the long-lasting burden of the disease. The goal of the current study was to explore socio-clinical factors that associate with specific self-management behaviors and patient activation among patients with Parkinson's disease. PwP were recruited from the Movement Disorders Institute, Department of Neurology, Rambam Health Care Campus. Eligible patients were assessed for cognitive status and filled questionnaires regarding socio-clinical factors included age, gender, severity of motor and non -motor symptoms, family and social support. Data about the comorbidities were retrieved from electronic medical records

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

December 30, 2021

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Patient's Activation Measure (PAM-13®️, Insignia Health)

    Patient Activation Measure (PAM) score. 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)

    through study completion, an average of 1 year

  • 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.

    through study completion, an average of 1 year

  • Utilization of rehabilitative treatments

    Participants reported about whether and how frequently they utilize physical therapy, occupational therapy, and speech and language pathology treatments

    Through study completion, an average of 1 year

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with PD who are treated in the Movement Disorders Institute, Department of Neurology, Rambam Health Care Campus.

You may qualify if:

  • Diagnosis of PD
  • Age \> 18

You may not qualify if:

  • Mini Mental State Exam\<20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galit Yogev-Seligmann

Haifa, Please Select..., 3498838, Israel

Location

Related Publications (1)

  • Duvdevani M, Yogev-Seligmann G, Schlesinger I, Nassar M, Erich I, Hadad R, Kafri M. Association of health behaviors with function and health-related quality of life among patients with Parkinson's disease. Isr J Health Policy Res. 2024 Jan 3;13(1):2. doi: 10.1186/s13584-023-00588-3.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 27, 2022

Study Start

May 1, 2019

Primary Completion

March 28, 2022

Study Completion

March 30, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations