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Parkinson's DiseasePhase 3NCT00518791

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

A Phase 3 study testing Multidisciplinary Care in people with Parkinson's Disease, run by Radboud University Medical Center at 6 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Multidisciplinary Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
6 sitesNetherlands
Study dates
Aug 2007to Aug 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • Ziekenhuis Groep Twente, Twenteborg Ziekenhuis

    Almelo

  • Ziekenhuis Rijnstate

    Arnhem

  • Wilhelmina Ziekenhuis Assen

    Assen

  • Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente

    Hengelo

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen

Other trials in Netherlands

About this study

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.

Read the detailed 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.

Being tested
Multidisciplinary Care, Usual Care
Keywords
Integrated health care system, Treatment effectiveness, Cost effectiveness, Program evaluation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary CareOther

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

  • Usual CareOther

    No altered organisation of care

Study groups in NCT00518791
Study groupRoleWhat they receive
IExperimentalMultidisciplinary Care
Receives: Other: Multidisciplinary Care
IIOtherUsual Care
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parkinson's Disease Quality of Life Questionnaire (PDQL)

    Measured: 8 months

  2. AMC Linear Disability Score (ALDS)

    Measured: 8 months

Secondary outcomes (13)

  1. SF-36 (secundary;utility score)

    Measured: 8 months

  2. UPDRS Motor Examination (part III)(secondary)

    Measured: 4 months

  3. UPDRS Complications of therapy (part IV)(tertiary)

    Measured: 4 months

  4. SPDDS(tertiary)

    Measured: 8 months

  5. Modified MACTAR scale(tertiary)

    Measured: 8 months

  6. Parkinson Activity Scale(tertiary)

    Measured: 4 months

  7. Costs (secondary)

    Measured: 8 months

  8. Frequency of falls (tertiary)

    Measured: 8 months

  9. Freezing of Gait Questionnaire (tertiary)

    Measured: 8 months

  10. Falls Efficacy Scale (tertiary)

    Measured: 8 months

  11. Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary)

    Measured: 8 months (Quest) and 4 months (Scale)

  12. Hospital Anxiety and Depression Scale (tertiary)

    Measured: 8 months

  13. Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary)

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00518791
Sponsor's protocol ID
2010-IP5.1
Status last verified
Oct 2010
First submitted
20 Aug 2007
Last updated
5 Nov 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23988337

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Multidisciplinary Care in people with Parkinson's Disease, run by Radboud University Medical Center at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parkinson's Disease Quality of Life Questionnaire (PDQL) (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00518791, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2010.

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