Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

3. März 2021 aktualisiert von: University of Sao Paulo General Hospital

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

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.

Studienübersicht

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

45

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • SP
      • Sao Paulo, SP, Brasilien, 05360-160
        • Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Face-to-face group
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
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.
Aktiver Komparator: Remote group
Remote group (RG), in which individuals followed 10 monthly remote lectures
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.
Schein-Komparator: Control group
Control group (CG), in which participants followed no education program (lectures)
Participants will follow no education program (lecture) and will be instructed to follow their usual routine for the treatment of the disease

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Health related Quality of life
Zeitfenster: baseline and immediately after the end of intervention
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Unifed Parkinson's Disease Rating Scale scores
Zeitfenster: baseline and immediately after the end of intervention
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
Zeitfenster: baseline and immediately after the end of intervention
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2020

Primärer Abschluss (Voraussichtlich)

30. April 2021

Studienabschluss (Voraussichtlich)

1. April 2022

Studienanmeldedaten

Zuerst eingereicht

25. Februar 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. März 2021

Zuerst gepostet (Tatsächlich)

5. März 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. März 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. März 2021

Zuletzt verifiziert

1. Februar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Parkinson Krankheit

3
Abonnieren