Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial

Parkinson's Disease Clinical Trial

Official title:

Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518791
• Other study ID #: 2010-IP5.1
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2007
• Last updated: November 4, 2010
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to evaluate the (cost) effectiveness of a new health care system in which an individualised multidisciplinary assessment is given to patients with Parkinson's Disease(PD)in combination with treatment by a dedicated team of specifically trained health professionals, compared to usual care. Overall, we anticipate to gain more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD.

Description:

PD is a complex disorder, with motor as well as non-motor symptoms. Despite the complexity of PD, management of the disease is often 'monodisciplinary' since most patients are only treated by a neurologist. Stimulating compensatory strategies by allied health professionals might offer additional therapeutic relief, but this assumption is mainly based on theoretical arguments and expert opinion. Even less is known about the claim that a multidisciplinary team of multiple professionals active in complementary domains (e.g. physiotherapy, occupational therapy and speech therapy) is superior to management by each of these professionals alone.

This study anticipates to provide more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in PD. Therefore, our multidisciplinary care concept (a comprehensive assessment by a dedicated multidisciplinary team and subsequent treatment by specifically trained health professionals) that is tailored to the patients' individual needs will be compared to usual care in terms of effectiveness and costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with Idiopathic PD, diagnosed according to the Brain Bank Criteria of the UK Parkinson's Disease Society

• Regular control by the neurologist

• Living independently in the community

• Able to complete the trial questionnaires

Exclusion Criteria:

• Atypical parkinsonian syndromes

• Hoehn and Yahr stage 5

• Severe cognitive impairment (MMSE<24)

• Presence of other neurological disorders

• Severe co-morbidity (e.g. cancer)

• Planned surgical procedure for PD within the intervention period

• Patients who have already visited the Multidisciplinary Assessment Center

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Multidisciplinary Care
A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).
• Usual Care
No altered organisation of care

Locations

Country	Name	City	State
Netherlands	Ziekenhuis Groep Twente, Twenteborg Ziekenhuis	Almelo
Netherlands	Ziekenhuis Rijnstate	Arnhem
Netherlands	Wilhelmina Ziekenhuis Assen	Assen
Netherlands	Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente	Hengelo
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Porticus, Stichting Nuts Ohra

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parkinson's Disease Quality of Life Questionnaire (PDQL)		8 months	No
Primary	AMC Linear Disability Score (ALDS)		8 months	No
Secondary	SF-36 (secundary;utility score)		8 months	No
Secondary	UPDRS Motor Examination (part III)(secondary)		4 months	No
Secondary	UPDRS Complications of therapy (part IV)(tertiary)		4 months	No
Secondary	SPDDS(tertiary)		8 months	No
Secondary	Modified MACTAR scale(tertiary)		8 months	No
Secondary	Parkinson Activity Scale(tertiary)		4 months	No
Secondary	Costs (secondary)		8 months	No
Secondary	Frequency of falls (tertiary)		8 months	No
Secondary	Freezing of Gait Questionnaire (tertiary)		8 months	No
Secondary	Falls Efficacy Scale (tertiary)		8 months	No
Secondary	Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary)		8 months (Quest) and 4 months (Scale)	No
Secondary	Hospital Anxiety and Depression Scale (tertiary)		8 months	No
Secondary	Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary)		8 months	No