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Efficiency of Physiotherapeutic Care in Parkinson's Disease

NCT ID: NCT00330694

Last Updated: 2008-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

708 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

Brief Summary

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In the course of their disease, most patients with Parkinson's Disease (PD) face mounting mobility deficits, including difficulties with walking, balance, posture and transfers. This frequently leads to (fear of) falls, injuries, loss of independence, and inactivity which causes social isolation and increases the risk of osteoporosis or cardiovascular disease. These mobility deficits are difficult to treat with drugs and neurosurgery. However, physiotherapy is deemed effective in improving mobility deficits in PD. Physiotherapy is widely prescribed for this purpose in the Netherlands. Yet, the efficiency of current "usual care" physiotherapy can be questioned, for two reasons. First, the referral process seems inadequate because patients are mainly referred by neurologists who often lack insight into the (im-)possibilities of physiotherapy for PD. Consequently, patients with a real need for physiotherapy are not always referred (undertreatment), whereas others without a real need are (overtreatment). Furthermore, most therapists treating PD patients are not specifically trained in treating these patients. This is not surprising because average therapists rarely treat more than two patients per year in their practice. Therefore, patients who are being referred probably receive suboptimal treatment.

The objective of this study is to evaluate whether the efficiency of physiotherapeutic care for patients with Parkinson's disease can be improved, at a reduced cost, by targeting two key elements of the current care system: a) inadequate referral by neurologists; b) suboptimal treatment by physiotherapists. We expect that optimal referral combined with expert treatment will increase the efficiency, as reflected by increased health benefits for patients at equal or reduced costs'.

Detailed Description

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Design In a Cluster Randomised Trial, 16 clusters will be randomly allocated to either network care (8 clusters with an altered organisation of physiotherapeutic care) or usual care (8 clusters with unchanged organisation of physiotherapeutic care). Clusters are formed by all PD patients living in the communities connected to participating regional hospitals in the 16 clusters.

The health care intervention in the experimental group has two elements: (a) an improved quality of referrals by neurologists; and (b) an improved quality of interventions by physiotherapists. Brief description Network Care: In each of the Network Care clusters, 5 to 7 motivated therapists are selected to enroll in a regional ParkNet and consequently trained. Training is focused at correct use of the evidence-based guidelines for physiotherapy in PD (Keus et al, 2006). This training consists of a 5-day competence-oriented course, web-based continues education supported by seminars, and use of a PD specific electronic patient record. Neurologists are informed about indications for referral to physiotherapy. Improved communication between neurologist and ParkNet therapists is initiated and supported.

Following implementation of the health care change, PD patients attending the neurological outpatient clinics of the individual hospitals within the clusters will be asked to participate. During a period of 6 months, PD patients will enrol in the study. Enrollees will be followed for 6 months to measure the use and quality of physiotherapy, patient health benefit and satisfaction, and costs.

Conditions

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Parkinson's Disease

Keywords

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Physical Therapy Organisation of care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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I

Implementation of ParkNet within 8 regions

Group Type EXPERIMENTAL

ParkNet

Intervention Type OTHER

Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.

II

Usual Care in 8 regions

Group Type OTHER

Usual Care

Intervention Type OTHER

No altered organisation of physiotherapy care in Parkinson's Disease

Interventions

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ParkNet

Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.

Intervention Type OTHER

Usual Care

No altered organisation of physiotherapy care in Parkinson's Disease

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with idiopathic PD, diagnosed according to the Brain Bank criteria of the UK Parkinson's Disease Society
* Living independently in the community
* Able to complete the trial questionnaires.

Exclusion Criteria

* Atypical parkinsonian syndromes
* Hoehn \& Yahr stage 5
* Severe cognitive impairment
* Presence of major psychiatric disorders
* Severe co-morbidity (e.g. cancer) that interferes with daily functioning.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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UMC St Radboud, Neurology

Principal Investigators

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Marten Munneke, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC st Radboud

Bastiaan R Bloem, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC st Radboud

Locations

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Jeroen Bosch Hospital

's-Hertogenbosch, , Netherlands

Site Status

Medisch Centrum Alkmaar

Alkmaar, , Netherlands

Site Status

Gelre Ziekenhuis

Apeldoorn, , Netherlands

Site Status

Ziekenhuis Gooi Noord

Blaricum, , Netherlands

Site Status

Reinier de Graaf Groep

Delft, , Netherlands

Site Status

Slingeland Ziekenhuis

Doetinchem, , Netherlands

Site Status

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Maxima Medisch Centrum

Eindhoven, , Netherlands

Site Status

Groene Hart Ziekenhuis

Gouda, , Netherlands

Site Status

Kennemer Gasthuis

Haarlem, , Netherlands

Site Status

Ziekenhuis Hilversum

Hilversum, , Netherlands

Site Status

Westfries Gasthuis

Hoorn, , Netherlands

Site Status

Ziekenhuis Bernhoven

Oss, , Netherlands

Site Status

Medisch Centrum Haaglanden, Westeinde

The Hague, , Netherlands

Site Status

Viecurie Medisch Centrum

Venlo, , Netherlands

Site Status

't Lange land ziekenhuis

Zoetermeer, , Netherlands

Site Status

Gelre Ziekenhuizen

Zutphen, , Netherlands

Site Status

Countries

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Netherlands

References

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Munneke M, Nijkrake MJ, Keus SH, Kwakkel G, Berendse HW, Roos RA, Borm GF, Adang EM, Overeem S, Bloem BR; ParkinsonNet Trial Study Group. Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial. Lancet Neurol. 2010 Jan;9(1):46-54. doi: 10.1016/S1474-4422(09)70327-8. Epub 2009 Dec 1.

Reference Type DERIVED
PMID: 19959398 (View on PubMed)

Other Identifiers

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945-04-357

Identifier Type: -

Identifier Source: org_study_id