Clinical trial NCT00518791: Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Official title: Integrated Multidisciplinary Care for Parkinson's Disease: a Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Integrated health care system
Treatment effectiveness
Cost effectiveness
Program evaluation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Nuts Ohra
name: Porticus
First posted: 2007-08-21
Enrollment: 301
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parkinson's Disease Quality of Life Questionnaire (PDQL)
timeFrame: 8 months
measure: AMC Linear Disability Score (ALDS)
timeFrame: 8 months
Secondary outcomes:
measure: SF-36 (secundary;utility score)
timeFrame: 8 months
measure: UPDRS Motor Examination (part III)(secondary)
timeFrame: 4 months
measure: UPDRS Complications of therapy (part IV)(tertiary)
timeFrame: 4 months
measure: SPDDS(tertiary)
timeFrame: 8 months
measure: Modified MACTAR scale(tertiary)
timeFrame: 8 months
measure: Parkinson Activity Scale(tertiary)
timeFrame: 4 months
measure: Costs (secondary)
timeFrame: 8 months
measure: Frequency of falls (tertiary)
timeFrame: 8 months
measure: Freezing of Gait Questionnaire (tertiary)
timeFrame: 8 months
measure: Falls Efficacy Scale (tertiary)
timeFrame: 8 months
measure: Non-Motor Symptom Assessment Scale and Quest for Parkinson's Disease (tertiary)
timeFrame: 8 months (Quest) and 4 months (Scale)
measure: Hospital Anxiety and Depression Scale (tertiary)
timeFrame: 8 months
measure: Caregiver burden assessed with BELA-A-k (secondary), SF-36 (tertiary), and HADS (tertiary)
timeFrame: 8 months
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis Assen
city: Hengelo
country: Netherlands
facility: Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
Study officials:
affiliation: UMC St Radboud
name: Marten Munneke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC St Radboud
name: Bastiaan R Bloem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC St Radboud
name: Marjolein A van der Marck, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.