Efficiency of Physiotherapeutic Care in Parkinson's Disease
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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 |
- Modified MACTAR scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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 June 18, 2013