NCT00518791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2007

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 5, 2010

Status Verified

October 1, 2010

Enrollment Period

3 years

First QC Date

August 20, 2007

Last Update Submit

November 4, 2010

Conditions

Parkinson's Disease

Keywords

Integrated health care systemTreatment effectivenessCost effectivenessProgram evaluation

Outcome Measures

Primary Outcomes (2)

  • Parkinson's Disease Quality of Life Questionnaire (PDQL)

    8 months

  • AMC Linear Disability Score (ALDS)

    8 months

Secondary Outcomes (13)

  • SF-36 (secundary;utility score)

    8 months

  • UPDRS Motor Examination (part III)(secondary)

    4 months

  • UPDRS Complications of therapy (part IV)(tertiary)

    4 months

  • SPDDS(tertiary)

    8 months

  • Modified MACTAR scale(tertiary)

    8 months

  • +8 more secondary outcomes

Study Arms (2)

I

EXPERIMENTAL

Multidisciplinary Care

Other: Multidisciplinary Care

II

OTHER

Usual Care

Other: Usual Care

Interventions

Multidisciplinary CareOTHER

A comprehensive individualised assessment by a dedicated multidisciplinary team (Multidisciplinary Assessment Center) and subsequent treatment by specifically trained health professionals (ParkinsonNet).

I
Usual CareOTHER

No altered organisation of care

II

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ziekenhuis Groep Twente, Twenteborg Ziekenhuis

Almelo, Netherlands

Location

Ziekenhuis Rijnstate

Arnhem, Netherlands

Location

Wilhelmina Ziekenhuis Assen

Assen, Netherlands

Location

Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente

Hengelo, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 23988337DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Patient Care Team

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 21, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 5, 2010

Record last verified: 2010-10

Locations

NL(6)