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

• ClinicalTrials.gov Identifier: NCT05211700
• Recruitment Status: Completed
• First Posted: January 27, 2022
• Last Update Posted: May 11, 2023
• Sponsor: University of Haifa
• Collaborator: Rambam Health Care Campus
• Information provided by (Responsible Party): Galit Yogev-Seligmann, University of Haifa

Study Description

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

Condition or disease	Intervention/treatment
Parkinson Disease	Other: This is an observational study, there is no intervention in this study.

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Socio-Clinical Factors Associated With Self-Management and Patient Activation in Parkinson's Disease
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: March 28, 2022
• Actual Study Completion Date: March 30, 2022

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Patient's Activation Measure (PAM-13®️, Insignia Health) [ Time Frame: through study completion, an average of 1 year ]

   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)

2. International Physical Activity Questionnaire- IPAQ-SHORT [ Time Frame: through study completion, an average of 1 year ]
   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.
3. Utilization of rehabilitative treatments [ Time Frame: Through study completion, an average of 1 year ]
   Participants reported about whether and how frequently they utilize physical therapy, occupational therapy, and speech and language pathology treatments

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

• Diagnosis of PD
• Age > 18

Exclusion Criteria:

• Mini Mental State Exam<20

Contacts and Locations

Locations

Israel

Galit Yogev-Seligmann

Haifa, Please Select..., Israel, 3498838

Sponsors and Collaborators

University of Haifa

Rambam Health Care Campus

More Information

• Responsible Party: Galit Yogev-Seligmann, Prinicipal Investigator, University of Haifa
• ClinicalTrials.gov Identifier: NCT05211700
• Other Study ID Numbers: 0067-19-RMB
• First Posted: January 27, 2022
• Last Update Posted: May 11, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases