Efficiency of Physiotherapeutic Care in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00330694
First received: May 24, 2006
Last updated: September 1, 2008
Last verified: September 2008
  Purpose

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'.


Condition Intervention Phase
Parkinson's Disease
Other: ParkNet
Other: Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficiency of Physiotherapeutic Care in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Modified MACTAR scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Enrollment: 708
Study Start Date: May 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Implementation of ParkNet within 8 regions
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.
Other Name: n.a.
II
Usual Care in 8 regions
Other: Usual Care
No altered organisation of physiotherapy care in Parkinson's Disease

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330694

Locations
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, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Marten Munneke, PhD UMC st Radboud
Principal Investigator: Bastiaan R Bloem, MD, PhD UMC st Radboud
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr M Munneke, UMC St Radboud, Neurology
ClinicalTrials.gov Identifier: NCT00330694     History of Changes
Other Study ID Numbers: 945-04-357
Study First Received: May 24, 2006
Last Updated: September 1, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Physical Therapy
Organisation of care

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 16, 2014