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Efficiency of Physiotherapeutic Care in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
ParkNet
Usual Care
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Physical Therapy, Organisation of care

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jeroen Bosch Hospital
  • Medisch Centrum Alkmaar
  • Gelre Ziekenhuis
  • Ziekenhuis Gooi Noord
  • Reinier de Graaf Groep
  • Medisch Centrum Haaglanden, Westeinde
  • Slingeland Ziekenhuis
  • Ziekenhuis Gelderse Vallei
  • Catharina Ziekenhuis
  • Maxima Medisch Centrum
  • Groene Hart Ziekenhuis
  • Kennemer Gasthuis
  • Ziekenhuis Hilversum
  • Westfries Gasthuis
  • Ziekenhuis Bernhoven
  • Viecurie Medisch Centrum
  • 't Lange land ziekenhuis
  • Gelre Ziekenhuizen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

I

II

Arm Description

Implementation of ParkNet within 8 regions

Usual Care in 8 regions

Outcomes

Primary Outcome Measures

Modified MACTAR scale

Secondary Outcome Measures

Parkinson Activity Scale (secondary)
Costs
Proportion of correct referrals (tertiary)
Quality of physiotherapy(tertiary)
Incidence of Falls (tertiary)
ALDS (tertiary)
SF-36 (tertiary)
EQ-5D (tertiary)
Satisfaction of patients and professionals (tertiary)
Self Assessment Disability Scale (tertiary)
Freezing of Gait Questionnaire {tertiary}
6 meter walk test {tertiary}
4x3 meter walk test (tertiary)
Single leg stance (tertiary)
Posture and Gait score (tertiary)
Timed Up and Go (tertiary)
Falls Efficacy Scale {tertiary}
9-hole pegboard test {tertiary}
Health Anxiety and Depression Scale (tertiary)
Physical activities assessed with the LAPAQ questionnaire (tertiary)
Caregiver burden assessed with the Care Giver Strain Index (tertiary)
PDQ-39 (Mobility Scale)

Full Information

First Posted
May 24, 2006
Last Updated
September 1, 2008
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00330694
Brief Title
Efficiency of Physiotherapeutic Care in Parkinson's Disease
Official Title
Efficiency of Physiotherapeutic Care in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Physical Therapy, Organisation of care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
708 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Implementation of ParkNet within 8 regions
Arm Title
II
Arm Type
Other
Arm Description
Usual Care in 8 regions
Intervention Type
Other
Intervention Name(s)
ParkNet
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
No altered organisation of physiotherapy care in Parkinson's Disease
Primary Outcome Measure Information:
Title
Modified MACTAR scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Parkinson Activity Scale (secondary)
Time Frame
6 months
Title
Costs
Time Frame
6 months
Title
Proportion of correct referrals (tertiary)
Time Frame
6 months
Title
Quality of physiotherapy(tertiary)
Time Frame
6 months
Title
Incidence of Falls (tertiary)
Time Frame
6 months
Title
ALDS (tertiary)
Time Frame
6 months
Title
SF-36 (tertiary)
Time Frame
6 months
Title
EQ-5D (tertiary)
Time Frame
6 months
Title
Satisfaction of patients and professionals (tertiary)
Time Frame
6 months
Title
Self Assessment Disability Scale (tertiary)
Time Frame
6 months
Title
Freezing of Gait Questionnaire {tertiary}
Time Frame
6 months
Title
6 meter walk test {tertiary}
Time Frame
6 months
Title
4x3 meter walk test (tertiary)
Time Frame
6 months
Title
Single leg stance (tertiary)
Time Frame
6 months
Title
Posture and Gait score (tertiary)
Time Frame
6 months
Title
Timed Up and Go (tertiary)
Time Frame
6 months
Title
Falls Efficacy Scale {tertiary}
Time Frame
6 months
Title
9-hole pegboard test {tertiary}
Time Frame
6 months
Title
Health Anxiety and Depression Scale (tertiary)
Time Frame
6 months
Title
Physical activities assessed with the LAPAQ questionnaire (tertiary)
Time Frame
6 months
Title
Caregiver burden assessed with the Care Giver Strain Index (tertiary)
Time Frame
6 months
Title
PDQ-39 (Mobility Scale)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marten Munneke, PhD
Organizational Affiliation
UMC st Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bastiaan R Bloem, MD, PhD
Organizational Affiliation
UMC st Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeroen Bosch Hospital
City
's Hertogenbosch
Country
Netherlands
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
Country
Netherlands
Facility Name
Gelre Ziekenhuis
City
Apeldoorn
Country
Netherlands
Facility Name
Ziekenhuis Gooi Noord
City
Blaricum
Country
Netherlands
Facility Name
Reinier de Graaf Groep
City
Delft
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden, Westeinde
City
Den Haag
Country
Netherlands
Facility Name
Slingeland Ziekenhuis
City
Doetinchem
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Eindhoven
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
Kennemer Gasthuis
City
Haarlem
Country
Netherlands
Facility Name
Ziekenhuis Hilversum
City
Hilversum
Country
Netherlands
Facility Name
Westfries Gasthuis
City
Hoorn
Country
Netherlands
Facility Name
Ziekenhuis Bernhoven
City
Oss
Country
Netherlands
Facility Name
Viecurie Medisch Centrum
City
Venlo
Country
Netherlands
Facility Name
't Lange land ziekenhuis
City
Zoetermeer
Country
Netherlands
Facility Name
Gelre Ziekenhuizen
City
Zutphen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19959398
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.
Results Reference
derived

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Efficiency of Physiotherapeutic Care in Parkinson's Disease

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