Clinical trial NCT00330694: Efficiency of Physiotherapeutic Care in Parkinson's Disease
Official title: Efficiency of Physiotherapeutic Care in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Physical Therapy
Organisation of care
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2006-05-29
Enrollment: 708
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified MACTAR scale
timeFrame: 6 months
Secondary outcomes:
measure: Parkinson Activity Scale (secondary)
timeFrame: 6 months
measure: Costs
timeFrame: 6 months
measure: Proportion of correct referrals (tertiary)
timeFrame: 6 months
measure: Quality of physiotherapy(tertiary)
timeFrame: 6 months
measure: Incidence of Falls (tertiary)
timeFrame: 6 months
measure: ALDS (tertiary)
timeFrame: 6 months
measure: SF-36 (tertiary)
timeFrame: 6 months
measure: EQ-5D (tertiary)
timeFrame: 6 months
measure: Satisfaction of patients and professionals (tertiary)
timeFrame: 6 months
measure: Self Assessment Disability Scale (tertiary)
timeFrame: 6 months
measure: Freezing of Gait Questionnaire {tertiary}
timeFrame: 6 months
measure: 6 meter walk test {tertiary}
timeFrame: 6 months
measure: 4x3 meter walk test (tertiary)
timeFrame: 6 months
measure: Single leg stance (tertiary)
timeFrame: 6 months
measure: Posture and Gait score (tertiary)
timeFrame: 6 months
measure: Timed Up and Go (tertiary)
timeFrame: 6 months
measure: Falls Efficacy Scale {tertiary}
timeFrame: 6 months
measure: 9-hole pegboard test {tertiary}
timeFrame: 6 months
measure: Health Anxiety and Depression Scale (tertiary)
timeFrame: 6 months
measure: Physical activities assessed with the LAPAQ questionnaire (tertiary)
timeFrame: 6 months
measure: Caregiver burden assessed with the Care Giver Strain Index (tertiary)
timeFrame: 6 months
measure: PDQ-39 (Mobility Scale)
timeFrame: 6 months
Other outcomes:
Locations:
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis
city: Blaricum
country: Netherlands
facility: Ziekenhuis Gooi Noord
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden, Westeinde
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Hilversum
country: Netherlands
facility: Ziekenhuis Hilversum
city: Hoorn
country: Netherlands
facility: Westfries Gasthuis
city: Oss
country: Netherlands
facility: Ziekenhuis Bernhoven
city: Venlo
country: Netherlands
facility: Viecurie Medisch Centrum
city: Zoetermeer
country: Netherlands
facility: 't Lange land ziekenhuis
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen
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
References:
citation: 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.