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

NCT04378127 | Completed DMC

• 1 other identifier: MisterParkinson
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

parkinson disease; burden; caregiver; educational program

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Study Arms (2)

educational program + traditional medical care

EXPERIMENTAL

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.

Other: Educational program

traditional medical care

NO INTERVENTION

traditional medical care

Interventions

Educational program OTHER

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.

educational program + traditional medical care

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Related Publications (1)

• De Pandis MF, Torti M, Rotondo R, Iodice L, Levi Della Vida M, Casali M, Vacca L, Viselli F, Servodidio V, Proietti S, Stocchi F. Therapeutic education for empowerment and engagement in patients with Parkinson's disease: A non-pharmacological, interventional, multicentric, randomized controlled trial. Front Neurol. 2023 Apr 18;14:1167685. doi: 10.3389/fneur.2023.1167685. eCollection 2023.

  PMID: 37144003 DERIVED

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 Officials

• fabrizio stocchi, md phd

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: May 10, 2015
• Primary Completion: December 10, 2018
• Study Completion: December 10, 2018
• Last Updated: April 10, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of study
• Access Criteria: request by email