Efficiency of Physiotherapeutic Care in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Efficiency of Physiotherapeutic Care in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330694
• Other study ID #: 945-04-357
• Status: Completed
• Phase: Phase 3
• First received: May 24, 2006
• Last updated: September 1, 2008
• Start date: May 2006
• Est. completion date: July 2007

Study information

• Verified date: September 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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'.

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 information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• ParkNet
Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.
• Usual Care
No altered organisation of physiotherapy care in Parkinson's Disease

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Hospital	's Hertogenbosch
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Gelre Ziekenhuis	Apeldoorn
Netherlands	Ziekenhuis Gooi Noord	Blaricum
Netherlands	Reinier de Graaf Groep	Delft
Netherlands	Medisch Centrum Haaglanden, Westeinde	Den Haag
Netherlands	Slingeland Ziekenhuis	Doetinchem
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Maxima Medisch Centrum	Eindhoven
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	Kennemer Gasthuis	Haarlem
Netherlands	Ziekenhuis Hilversum	Hilversum
Netherlands	Westfries Gasthuis	Hoorn
Netherlands	Ziekenhuis Bernhoven	Oss
Netherlands	Viecurie Medisch Centrum	Venlo
Netherlands	't Lange land ziekenhuis	Zoetermeer
Netherlands	Gelre Ziekenhuizen	Zutphen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified MACTAR scale		6 months	No
Secondary	Parkinson Activity Scale (secondary)		6 months	No
Secondary	Costs		6 months	No
Secondary	Proportion of correct referrals (tertiary)		6 months	No
Secondary	Quality of physiotherapy(tertiary)		6 months	No
Secondary	Incidence of Falls (tertiary)		6 months	Yes
Secondary	ALDS (tertiary)		6 months	No
Secondary	SF-36 (tertiary)		6 months	No
Secondary	EQ-5D (tertiary)		6 months	No
Secondary	Satisfaction of patients and professionals (tertiary)		6 months	No
Secondary	Self Assessment Disability Scale (tertiary)		6 months	No
Secondary	Freezing of Gait Questionnaire {tertiary}		6 months	No
Secondary	6 meter walk test {tertiary}		6 months	No
Secondary	4x3 meter walk test (tertiary)		6 months	No
Secondary	Single leg stance (tertiary)		6 months	No
Secondary	Posture and Gait score (tertiary)		6 months	No
Secondary	Timed Up and Go (tertiary)		6 months	No
Secondary	Falls Efficacy Scale {tertiary}		6 months	No
Secondary	9-hole pegboard test {tertiary}		6 months	No
Secondary	Health Anxiety and Depression Scale (tertiary)		6 months	No
Secondary	Physical activities assessed with the LAPAQ questionnaire (tertiary)		6 months	No
Secondary	Caregiver burden assessed with the Care Giver Strain Index (tertiary)		6 months	No
Secondary	PDQ-39 (Mobility Scale)		6 months	No