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NCT Number: NCT05211700

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Galit Yogev-Seligmann

Haifa, Please Select..., 3498838, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of PD
  • Age > 18

Exclusion criteria

  • Mini Mental State Exam<20

Treatment and study plan

This is an observational study, there is no intervention in this study.

Other

There is no intervention in this study

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Rambam Health Care Campus

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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