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Completed

NCT Number: NCT00518791

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ziekenhuis Groep Twente, Twenteborg Ziekenhuis, Almelo, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidisciplinary Care

Other

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

Usual Care

Other

No altered organisation of care

Primary outcomes

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

    Time frame: 8 months

  2. AMC Linear Disability Score (ALDS)

    Time frame: 8 months

Secondary outcomes

  1. SF-36 (secundary;utility score)

    Time frame: 8 months

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

    Time frame: 4 months

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

    Time frame: 4 months

  4. SPDDS(tertiary)

    Time frame: 8 months

  5. Modified MACTAR scale(tertiary)

    Time frame: 8 months

  6. Parkinson Activity Scale(tertiary)

    Time frame: 4 months

  7. Costs (secondary)

    Time frame: 8 months

  8. Frequency of falls (tertiary)

    Time frame: 8 months

  9. Freezing of Gait Questionnaire (tertiary)

    Time frame: 8 months

  10. Falls Efficacy Scale (tertiary)

    Time frame: 8 months

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

    Time frame: 8 months (Quest) and 4 months (Scale)

  12. Hospital Anxiety and Depression Scale (tertiary)

    Time frame: 8 months

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

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Porticus
  • Stichting Nuts Ohra

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 21, 2007
Registry last updated
Nov 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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