Multidisciplinary Health Educational Program Based on Centered People Care Model in Parkinson's Disease

Study Overview
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Brief Summary
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The objective of this study is to compare the effects of two similar long-term interprofessional programs, one of them delivers by in-person classes, and another delivers by online classes on the quality of life of people with Parkinson's. Method: People with PD will be randomized into 3 groups: (1) Face-to-face group, in which participants, in groups of 10 persons, followed a multidisciplinary health education program composed of 10 monthly face-to-face lectures; (2) Remote group, in which individuals followed the same lectures delivered by online; and (3) Control group, in which participants followed no lecture. The participants will be evaluated before (BED) and after (ABP) the education program conclusion (10 lectures). Health quality of life was adopted as a primary outcome. Independence in daily living activities, motor and non-motor symptoms severity, and global cognitive capacity was adopted as secondary measures, Besides, all participants will be asked to answer a survey to evaluate the knowledge improvement of key learning points of lectures. The results will be analyzed by ANOVA for repeated measures.

Detailed Description
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Parkinson's disease is a large cause of disability worldwide. The complex combination of motor and non-motor symptoms brings an increasing impairment in functionality and, consequently, a progressively decrease in the quality of life of the people living with PD and their families. The World Health Organization (WHO) recommends that for health care, especially in chronic diseases, care should be centered on the person (people-centered care). This model enlarges the focus on biological aspects, including psychological and social aspects, building a multidimensional perspective on an individual, which can only be reached by integrated and interprofessional care. According to this model, education is crucial to empower the person to occupy an active role in the health process, gaining greater control over decisions and actions affecting their health. Patient empowerment has been associated with positive health and clinical outcomes, including improved disease management, effective use of health services, improved health status, and medication adherence. However, there are several barriers for participants to attending this kind of program. Reasons for nonparticipation include mobility-reducing physical health issues, time constraints, distance, insufficient funds, lack of respite care if caring for someone else, and transportation. Thus, using a home-based video class may be one opportunity to reduce these known barriers and improve the accessibility of education programs. This delivery strategy can be beneficial for no high-income countries. Objective: The objective of this study is to compare the effects of two similar long-term interprofessional programs, one of them delivers by in-person classes, and another delivers by online classes on the quality of life of people with Parkinson's. Method: People with a confirmed diagnosis of Idiopathic Parkinson's disease, in stage 1-4 of disease evolution according to Hoehn and Yahr classification will be randomized into 3 groups: (1) Face-to-face group (FFG), in which participants, in groups of 10 persons, followed a multidisciplinary health education program composed of 10 monthly face-to-face lectures; (2) Remote group (RG), in which individuals followed the same lectures delivered by online; and (3) Control group (CG), in which participants followed no lecture. People who have severe cognitive decline and uncorrected visual or hearing impairment will be excluded. Participants from both groups will be instructed to follow their usual routine for the treatment of the disease. The lectures on the management of motor and non-motor alterations associate with PD will be offered by a nurse, physiotherapist, occupational therapist, speech therapist, neurologist, lawyer, nutritionist, and psychologist. The participants will be evaluated before (BED) and after (ABP) the education program conclusion (10 lectures). Health quality of life, adopted as a primary outcome, will be evaluated by Parkinson´s disease questionnaire 39 (PDQ-39). The independence in daily living activities, motor and non-motor symptoms severity, and global cognitive capacity, adopted as secondary measures, will be evaluated by Unified Parkinson´s disease rating scale (UPDRS) and Montreal Cognitive Assessment (MoCA), respectively. Besides, all participants will be asked to answer a survey to evaluate the knowledge improvement of key learning points of lectures. The survey consisted of 20 questions (2 per lecture) where the minimum level (score 0) indicated the absence of knowledge and maximal level (score 5) indicated the full understanding of lectures' key points. The results will be analyzed by ANOVA for repeated measures considering as factor group (FFG, RG, CG) and assessment points (BED, AEP).

Official Title
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Multidisciplinary Health Educational Program Based on Centered People Care Model in Parkinson's Disease: Comparison Between Remote and Face-to-face Delivery

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Education program based on 10 monthly lectures
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Idiopathic Parkinson's disease Must have acess to internet. Exclusion Criteria: Severe cognitive decline Severe visual impairment Severe hearing impairment

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stratified, single-blind, parallel-group, randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face-to-face group<br>Face-to-face group (FFG), in which participants, in groups of 10 persons, followed a multidisciplinary health education program composed of 10 monthly face-to-face lectures | Other: Education program based on 10 monthly lectures<br>* The education program consist of 10 lectures on the management of motor and non-motor alterations associate with PD will be offered by a nurse, physiotherapist, occupational therapist, speech therapist, neurologist, lawyer, nutritionist, and psychologist.<br>|
| Active Comparator: Remote group<br>Remote group (RG), in which individuals followed 10 monthly remote lectures | Other: Education program based on 10 monthly lectures<br>* The education program consist of 10 lectures on the management of motor and non-motor alterations associate with PD will be offered by a nurse, physiotherapist, occupational therapist, speech therapist, neurologist, lawyer, nutritionist, and psychologist.<br>|
| Sham Comparator: Control group<br>Control group (CG), in which participants followed no education program (lectures) | Other: No intervention<br>* Participants will follow no education program (lecture) and will be instructed to follow their usual routine for the treatment of the disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health related Quality of life | Parkinson´s disease questionnaire 39 (PDQ-39), PDQ-39 is a widely used and acknowledged disease-specific, self-reported questionnaire. It contains 39 questions covering eight distinct domains: mobility, activities of daily living, emotional wellbeing, stigma, social support, cognition, communication, and bodily discomfort. The score for each question ranges from 0 to 4 points, with higher scores indicating higher levels of perceived problems. A change of ≥1.6 points on the PDQ-39 total score after 6 months represents a minimally clinically important difference | baseline and immediately after the end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Unifed Parkinson's Disease Rating Scale scores | UPDRS - Part I: Non-Motor Experiences of Daily Living which has six rater-based items and seven for patient self-assessment; UPDRS - Part II: Motor experiences of daily living, with 13 patient-based items; UPDRS - Part III: Motor examination, 18 items based on clinical tests. Each item scores from 0 (normal) to 4 (severe) and total scores are obtained from the sum of the corresponding item scores for each part. | baseline and immediately after the end of intervention | 
| Change in Montreal Cognitive Assessment scores | Montreal Cognitive Assessment (MoCA): The 30-point designed to detect mild cognitive impairment and reportedly takes <10 min to administer with scores <26 defined as abnormal. | baseline and immediately after the end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Telehealth, People centered-care, Quality of life