Socio-Clinical Factors Associated With Self-Management in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Socio-Clinical Factors Associated With Self-Management and Patient Activation in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211700
• Other study ID #: 0067-19-RMB
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: May 2023
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

n Parkinson's disease (PD), implementation of self-management strategies together with high patient activation may be an effective tool in fighting the long-lasting burden of the disease, but little is known about its determinant.

The aims of this study, conducted among patients with PD are to (1) test the association between socio-clinical factors that includes age, gender, cognitive status, comorbidities, disease severity (motor and non-motor symptoms) and social support and SMBs including utilization of rehabilitative treatments (an aspect of medical management), physical activity (an aspects of lifestyle management), and patient activation, and (2) to develop predictive model for each of these three aspects of SMB, based on socio-clinical factors that includes age, gender, cognitive status, comorbidities, disease severity (motor and non-motor symptoms) and social support.

A cross-sectional study of 100 patients that attend a Movement Disorder Clinic with PD will be conducted. Participation will include one evaluation session of approximately 90 minutes. Information about socio-clinical characteristics and self-management behaviors will be collected using demographic questionnaires, standard questionnaires and from electronic medical records. Regression model will test the association between sociodemographic characteristics and self-management behaviors and patient activation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 30, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of PD

• Age > 18

Exclusion Criteria:

• Mini Mental State Exam<20

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• This is an observational study, there is no intervention in this study.
There is no intervention in this study

Locations

Country	Name	City	State
Israel	Galit Yogev-Seligmann	Haifa	Please Select...

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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.	through study completion, an average of 1 year
Primary	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