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

NCT04783129 | Unknown

• 1 other identifier: AMPARO study
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Telehealth; People centered-care; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Unifed Parkinson's Disease Rating Scale scores

  baseline and immediately after the end of intervention

• Change in Montreal Cognitive Assessment scores

  baseline and immediately after the end of intervention

Study Arms (3)

Face-to-face group

EXPERIMENTAL

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

Remote group

ACTIVE COMPARATOR

Remote group (RG), in which individuals followed 10 monthly remote lectures

Other: Education program based on 10 monthly lectures

Control group

SHAM COMPARATOR

Control group (CG), in which participants followed no education program (lectures)

Other: No intervention

Interventions

Education program based on 10 monthly lectures OTHER

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.

Face-to-face group; Remote group

No intervention OTHER

Participants will follow no education program (lecture) and will be instructed to follow their usual routine for the treatment of the disease

Control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Idiopathic Parkinson's disease Must have acess to internet.

You may not qualify if:

• Severe cognitive decline Severe visual impairment Severe hearing impairment

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

São Paulo, São Paulo, 05360-160, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All groups will be assessed before (baseline), and after the end of the intervention by a blinded examiner
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stratified, single-blind, parallel-group, randomised controlled trial

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 5, 2021
• Study Start: March 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 1, 2022
• Last Updated: March 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)