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

This study has been completed.
Sponsor:
Collaborators:
Stichting Nuts Ohra
Porticus
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00518791
First received: August 20, 2007
Last updated: November 4, 2010
Last verified: October 2010

August 20, 2007
November 4, 2010
August 2007
August 2010   (final data collection date for primary outcome measure)
  • Parkinson's Disease Quality of Life Questionnaire (PDQL) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • AMC Linear Disability Score (ALDS) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Parkinson's Disease Quality of Life Questionnaire (PDQL) [ Time Frame: 8 months ]
  • AMC Linear Disability Score (ALDS) [ Time Frame: 8 months ]
Complete list of historical versions of study NCT00518791 on ClinicalTrials.gov Archive Site
  • SF-36 (secundary;utility score) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • UPDRS Motor Examination (part III)(secondary) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • UPDRS Complications of therapy (part IV)(tertiary) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • SPDDS(tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Modified MACTAR scale(tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Parkinson Activity Scale(tertiary) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Costs (secondary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Frequency of falls (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Freezing of Gait Questionnaire (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Falls Efficacy Scale (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary) [ Time Frame: 8 months (Quest) and 4 months (Scale) ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 8 months ]
  • UPDRS Motor Examination (part III) [ Time Frame: 4 months ]
  • UPDRS Complications of therapy (part IV) [ Time Frame: 4 months ]
  • SPDDS [ Time Frame: 8 months ]
  • Modified MACTAR scale [ Time Frame: 8 months ]
  • Parkinson Activity Scale [ Time Frame: 4 months ]
  • Costs [ Time Frame: 8 months ]
  • Frequency of falls [ Time Frame: 8 months ]
  • Freezing of Gait Questionnaire [ Time Frame: 8 months ]
  • Falls Efficacy Scale [ Time Frame: 8 months ]
  • Non-Motor Symptom Assessment Scale for Parkinson's Disease [ Time Frame: 8 months ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 8 months ]
  • Caregiver burden assessed with BELA-A-k, SF-36, and HADS [ Time Frame: 8 months ]
Not Provided
Not Provided
 
Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Parkinson's Disease
  • Other: Multidisciplinary Care
    A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).
    Other Name: n.a.
  • Other: Usual Care
    No altered organisation of care
    Other Name: n.a.
  • Experimental: I
    Multidisciplinary Care
    Intervention: Other: Multidisciplinary Care
  • II
    Usual Care
    Intervention: Other: Usual Care
van der Marck MA, Munneke M, Mulleners W, Hoogerwaard EM, Borm GF, Overeem S, Bloem BR; IMPACT study group. Integrated multidisciplinary care in Parkinson's disease: a non-randomised, controlled trial (IMPACT). Lancet Neurol. 2013 Oct;12(10):947-56. doi: 10.1016/S1474-4422(13)70196-0. Epub 2013 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00518791
2010-IP5.1
No
Dr M Munneke, UMC St Radboud, Neurology
Radboud University
  • Stichting Nuts Ohra
  • Porticus
Principal Investigator: Marten Munneke, PhD UMC St Radboud
Principal Investigator: Bastiaan R Bloem, MD, PhD UMC St Radboud
Principal Investigator: Marjolein A van der Marck, MSc UMC St Radboud
Radboud University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP