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

NCT ID: NCT04378127

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-10
• Study Completion Date: 2018-12-10

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

educational program + 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.

Group Type: EXPERIMENTAL

Educational program

Intervention Type: 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.

traditional medical care

traditional medical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational program

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele Roma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

fabrizio stocchi, md phd

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

References

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.

Reference Type: DERIVED

PMID: 37144003 (View on PubMed)

Other Identifiers

MisterParkinson

Identifier Type: -

Identifier Source: org_study_id