Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04783129 |
| Other study ID # |
AMPARO study |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2020 |
| Est. completion date |
April 2022 |
Study information
| Verified date |
February 2021 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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).
