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Mister Parkinson: Educational Therapy in Parkinson's Disease (PD)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational program
Sponsored by
IRCCS San Raffaele Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring parkinson disease, burden, caregiver, educational program

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • idiopathic Parkinson's disease (according to UK Brain Bank criteria)
  • being aged 20-80 years
  • being able to complete questionnaires
  • having no severe cognitive impairment (mini-mental state examination ≥24)
  • having a stable caregiver

Exclusion Criteria:

  • atypical parkinsonian
  • severe comorbidity significantly interfering with quality of life

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    educational program + traditional medical care

    traditional medical care

    Arm Description

    The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.

    traditional medical care

    Outcomes

    Primary Outcome Measures

    OFF hours
    The primary outcome was change from baseline to end of study in the mean daily OFF hours evaluated with the Hauser diary. Expected increase in the mean time spent in ON in at least 50% of treated patients (OR ≥1.5) compared to the control group.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2020
    Last Updated
    October 17, 2022
    Sponsor
    IRCCS San Raffaele Roma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04378127
    Brief Title
    Mister Parkinson: Educational Therapy in Parkinson's Disease (PD)
    Official Title
    Educational Therapy in Parkinson's Disease (PD): A Non-pharmacological Interventional, Multicentric, Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    May 10, 2015 (Actual)
    Primary Completion Date
    December 10, 2018 (Actual)
    Study Completion Date
    December 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IRCCS San Raffaele Roma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. These can contribute to the burden of the disease on patients and their caregivers, and often remain unrecognized and untreated. This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care.
    Detailed Description
    Parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. A multidisciplinary and comprehensive approach, based on the chronic care model, is considered the best way to manage motor and non-motor symptoms of the disease, although this model of care is still not standardized and previous trials showed conflicting results. The study planned to enrol 40 advanced PD patients and related caregivers for each investigational site. This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care. The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    parkinson disease, burden, caregiver, educational program

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    educational program + traditional medical care
    Arm Type
    Experimental
    Arm Description
    The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.
    Arm Title
    traditional medical care
    Arm Type
    No Intervention
    Arm Description
    traditional medical care
    Intervention Type
    Other
    Intervention Name(s)
    Educational program
    Intervention Description
    The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.
    Primary Outcome Measure Information:
    Title
    OFF hours
    Description
    The primary outcome was change from baseline to end of study in the mean daily OFF hours evaluated with the Hauser diary. Expected increase in the mean time spent in ON in at least 50% of treated patients (OR ≥1.5) compared to the control group.
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: idiopathic Parkinson's disease (according to UK Brain Bank criteria) being aged 20-80 years being able to complete questionnaires having no severe cognitive impairment (mini-mental state examination ≥24) having a stable caregiver Exclusion Criteria: atypical parkinsonian severe comorbidity significantly interfering with quality of life
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    fabrizio stocchi, md phd
    Organizational Affiliation
    IRCCS San Raffaele
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    after the end of sudy
    IPD Sharing Time Frame
    after the end of study
    IPD Sharing Access Criteria
    request by email

    Learn more about this trial

    Mister Parkinson: Educational Therapy in Parkinson's Disease (PD)

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