Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 11:40 PM
Study NCT ID:
NCT00330694
Status:
COMPLETED
Last Update Posted:
2008-09-03
First Post:
2006-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficiency of Physiotherapeutic Care in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 708}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-01', 'studyFirstSubmitDate': '2006-05-24', 'studyFirstSubmitQcDate': '2006-05-24', 'lastUpdatePostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified MACTAR scale', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Parkinson Activity Scale (secondary)', 'timeFrame': '6 months'}, {'measure': 'Costs', 'timeFrame': '6 months'}, {'measure': 'Proportion of correct referrals (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Quality of physiotherapy(tertiary)', 'timeFrame': '6 months'}, {'measure': 'Incidence of Falls (tertiary)', 'timeFrame': '6 months'}, {'measure': 'ALDS (tertiary)', 'timeFrame': '6 months'}, {'measure': 'SF-36 (tertiary)', 'timeFrame': '6 months'}, {'measure': 'EQ-5D (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Satisfaction of patients and professionals (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Self Assessment Disability Scale (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Freezing of Gait Questionnaire {tertiary}', 'timeFrame': '6 months'}, {'measure': '6 meter walk test {tertiary}', 'timeFrame': '6 months'}, {'measure': '4x3 meter walk test (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Single leg stance (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Posture and Gait score (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Timed Up and Go (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Falls Efficacy Scale {tertiary}', 'timeFrame': '6 months'}, {'measure': '9-hole pegboard test {tertiary}', 'timeFrame': '6 months'}, {'measure': 'Health Anxiety and Depression Scale (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Physical activities assessed with the LAPAQ questionnaire (tertiary)', 'timeFrame': '6 months'}, {'measure': 'Caregiver burden assessed with the Care Giver Strain Index (tertiary)', 'timeFrame': '6 months'}, {'measure': 'PDQ-39 (Mobility Scale)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical Therapy', 'Organisation of care'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '19959398', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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\'.', 'detailedDescription': '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.\n\nThe 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.\n\nFollowing 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with idiopathic PD, diagnosed according to the Brain Bank criteria of the UK Parkinson's Disease Society\n* Living independently in the community\n* Able to complete the trial questionnaires.\n\nExclusion Criteria:\n\n* Atypical parkinsonian syndromes\n* Hoehn \\& Yahr stage 5\n* Severe cognitive impairment\n* Presence of major psychiatric disorders\n* Severe co-morbidity (e.g. cancer) that interferes with daily functioning."}, 'identificationModule': {'nctId': 'NCT00330694', 'briefTitle': "Efficiency of Physiotherapeutic Care in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': "Efficiency of Physiotherapeutic Care in Parkinson's Disease", 'orgStudyIdInfo': {'id': '945-04-357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'Implementation of ParkNet within 8 regions', 'interventionNames': ['Other: ParkNet']}, {'type': 'OTHER', 'label': 'II', 'description': 'Usual Care in 8 regions', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'ParkNet', 'type': 'OTHER', 'description': "Development of a network of dedicated physiotherapist with specific expertise in Parkinson's Disease and structured referrals to these ParkNet therapists by neurologists.", 'armGroupLabels': ['I']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': "No altered organisation of physiotherapy care in Parkinson's Disease", 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Hospital', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medisch Centrum Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuis', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Blaricum', 'country': 'Netherlands', 'facility': 'Ziekenhuis Gooi Noord', 'geoPoint': {'lat': 52.2725, 'lon': 5.24167}}, {'city': 'Delft', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Groep', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'city': 'Doetinchem', 'country': 'Netherlands', 'facility': 'Slingeland Ziekenhuis', 'geoPoint': {'lat': 51.965, 'lon': 6.28889}}, {'city': 'Ede', 'country': 'Netherlands', 'facility': 'Ziekenhuis Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Maxima Medisch Centrum', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Groene Hart Ziekenhuis', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'city': 'Hilversum', 'country': 'Netherlands', 'facility': 'Ziekenhuis Hilversum', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'city': 'Hoorn', 'country': 'Netherlands', 'facility': 'Westfries Gasthuis', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'city': 'Oss', 'country': 'Netherlands', 'facility': 'Ziekenhuis Bernhoven', 'geoPoint': {'lat': 51.765, 'lon': 5.51806}}, {'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Medisch Centrum Haaglanden, Westeinde', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Venlo', 'country': 'Netherlands', 'facility': 'Viecurie Medisch Centrum', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}, {'city': 'Zoetermeer', 'country': 'Netherlands', 'facility': "'t Lange land ziekenhuis", 'geoPoint': {'lat': 52.0575, 'lon': 4.49306}}, {'city': 'Zutphen', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuizen', 'geoPoint': {'lat': 52.13833, 'lon': 6.20139}}], 'overallOfficials': [{'name': 'Marten Munneke, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC st Radboud'}, {'name': 'Bastiaan R Bloem, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC st Radboud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr M Munneke', 'oldOrganization': 'UMC St Radboud, Neurology'}}}}