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Efficiency of Physiotherapeutic Care in Parkinson's Disease

Phase 3
Completed
Conditions
Parkinson's Disease
Interventions
Other: ParkNet
Other: Usual Care
Registration Number
NCT00330694
Lead Sponsor
Radboud University Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
708
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IParkNetImplementation of ParkNet within 8 regions
IIUsual CareUsual Care in 8 regions
Primary Outcome Measures
NameTimeMethod
Modified MACTAR scale6 months
Secondary Outcome Measures
NameTimeMethod
Parkinson Activity Scale (secondary)6 months
Costs6 months
Proportion of correct referrals (tertiary)6 months
Quality of physiotherapy(tertiary)6 months
Incidence of Falls (tertiary)6 months
ALDS (tertiary)6 months
SF-36 (tertiary)6 months
EQ-5D (tertiary)6 months
Satisfaction of patients and professionals (tertiary)6 months
Self Assessment Disability Scale (tertiary)6 months
Freezing of Gait Questionnaire {tertiary}6 months
6 meter walk test {tertiary}6 months
4x3 meter walk test (tertiary)6 months
Single leg stance (tertiary)6 months
Posture and Gait score (tertiary)6 months
Timed Up and Go (tertiary)6 months
Falls Efficacy Scale {tertiary}6 months
9-hole pegboard test {tertiary}6 months
Health Anxiety and Depression Scale (tertiary)6 months
Physical activities assessed with the LAPAQ questionnaire (tertiary)6 months
Caregiver burden assessed with the Care Giver Strain Index (tertiary)6 months
PDQ-39 (Mobility Scale)6 months

Trial Locations

Locations (18)

Medisch Centrum Haaglanden, Westeinde

🇳🇱

Den Haag, Netherlands

Medisch Centrum Alkmaar

🇳🇱

Alkmaar, Netherlands

Westfries Gasthuis

🇳🇱

Hoorn, Netherlands

Slingeland Ziekenhuis

🇳🇱

Doetinchem, Netherlands

Ziekenhuis Hilversum

🇳🇱

Hilversum, Netherlands

Viecurie Medisch Centrum

🇳🇱

Venlo, Netherlands

Jeroen Bosch Hospital

🇳🇱

's Hertogenbosch, Netherlands

Ziekenhuis Gooi Noord

🇳🇱

Blaricum, Netherlands

Ziekenhuis Gelderse Vallei

🇳🇱

Ede, Netherlands

Reinier de Graaf Groep

🇳🇱

Delft, Netherlands

Gelre Ziekenhuis

🇳🇱

Apeldoorn, Netherlands

Catharina Ziekenhuis

🇳🇱

Eindhoven, Netherlands

Kennemer Gasthuis

🇳🇱

Haarlem, Netherlands

Maxima Medisch Centrum

🇳🇱

Eindhoven, Netherlands

Groene Hart Ziekenhuis

🇳🇱

Gouda, Netherlands

Ziekenhuis Bernhoven

🇳🇱

Oss, Netherlands

Gelre Ziekenhuizen

🇳🇱

Zutphen, Netherlands

't Lange land ziekenhuis

🇳🇱

Zoetermeer, Netherlands

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