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Trial record 35 of 243919 for:    Diseases

Cost-effectiveness of Nursing Interventions for Patients With PD (NICE-PD)

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ClinicalTrials.gov Identifier: NCT03830190
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Zambon SpA
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Background: Current guidelines recommend that every person with Parkinson's disease (PD) should have access to Parkinson's Disease Nurse Specialist (PDNS) care. Thus, hospitals increasingly offer PDNS care to their patients with PD. However, there is currently little scientific evidence on the cost-effectiveness of PDNS care. Consequently, many hospitals lack the nursing capacity to offer PDNS care to all patients, which creates unequal access to care and possibly avoidable disability and costs.

Objective: The investigators aim to study the (cost-)effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS care for people with PD in all disease stages. To gain more insight into the used interventions and their effects, a subgroup analysis will be performed based on disease duration (diagnosis made <5, 5-10, or >10 years ago).

Methods: The investigators will perform an 18-month, single-blind, randomized controlled clinical trial in eight community hospitals in the Netherlands. A total of 240 people with idiopathic PD that have not been treated by a PDNS over the past two years will be included, independent of disease severity or duration. In each hospital, 30 patients will randomly be allocated in a 1:1 ratio to either PDNS care according to the Dutch Guideline on PDNS care or no nursing intervention (continuing usual care). For the allocation of participants, a computer-generated list of random numbers will be used. The co-primary outcome measures are Quality of Life (QoL) and motor symptoms. Secondary outcomes include PD symptoms, mobility, non-motor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver quality of life, coping skills and caregiver burden. Data will be collected after 12 months and 18 months. A healthcare utilization and productivity loss questionnaire will be completed every 3 months by both the patient and the caregiver.

Hypothesis: The investigators hypothesize that, by offering more patients access to PDNS care, QoL will increase with equal healthcare costs. Increasing direct medical costs (for nurse staffing) will be offset by a reduced number of consultations with the general practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care is needed.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Parkinson's disease nurse specialist care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with 2 study arms: the intervention group and the control group. Participants are allocated to each arm in a 1:1 ratio.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Due to the type of intervention (Parkinson's disease nurse specialist care), the participant and care provider cannot be masked. The investigator and outcome assessor (conducting the questionnaires) will be blinded.
Primary Purpose: Treatment
Official Title: Cost-Effectiveness of Specialized Nursing Interventions for Patients With Parkinson's Disease
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Parkinson's disease nurse specialist care
Other: Parkinson's disease nurse specialist care
Specialized nursing care provided by a Parkinson's disease nurse specialist
Other Name: PDNS care

No Intervention: Control group
No intervention



Primary Outcome Measures :
  1. Disease-specific health-related quality of life: Parkinson's disease Questionnaire (PDQ-39) [ Time Frame: Baseline, change from baseline quality of life at 12 months, change from baseline quality of life at 18 months ]
    Parkinson's disease Questionnaire (PDQ-39). Total score range: 0-100, including 8 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.

  2. Motor symptoms [ Time Frame: Baseline, change from baseline motor symptoms at 12 months, change from baseline motor symptoms at 18 months ]
    Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III). Total score range: 0-132. A lower score means a better outcome.


Secondary Outcome Measures :
  1. Longitudinal Parkinson's disease symptoms [ Time Frame: Baseline, change from baseline Parkinson's disease symptoms at 12 months, change from baseline Parkinson's disease symptoms at 18 months ]
    Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part I, II, IV (MDS-UPDRS part I, II, IV). Total score range: 0-260 (including the MDS-UPDRS part III), including 4 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.

  2. Mobility [ Time Frame: Baseline, change from baseline TUG at 12 months, change from baseline TUG at 18 months ]
    Timed up and Go (TUG). A lower score means a better outcome.

  3. Non-motor symptoms (anxiety and depression) [ Time Frame: Baseline, 12 months, 18 months ]
    Hamilton Anxiety and Depression Scale (HADS). Total score range: 0-21, including 2 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.

  4. Non-motor symptoms [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    Scales for Outcomes in Parkinson's disease - Autonomic Questionnaire (SCOPA-AUT). Total score range: 0-69, including 6 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.

  5. Health-related quality of life: EuroQoL5D (EQ5D) [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    EuroQoL5D (EQ5D). Summary index with a maximum score of 1, including 5 dimensions. A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general health status with a total score range of 0-100. A higher score means a better outcome.

  6. Experienced quality of and experience with provided healthcare: Consumer Quality Index (CQI) [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    Consumer Quality Index (CQI). There is no minimum or maximum score (the measure consists of a number of qualitative and experience questions). Therefore, higher values do not correlate with a better or worse outcome.

  7. Self-management [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    Patient Activation Measure (PAM13). Total score range: 0-100, including a division in 4 activation levels. A higher score means a higher activation level (= the patient has made most of the necessary behavior changes to manage their disease).

  8. Medication adherence [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    Morisky Medication Adherence Scale (MMAS). Total score range: 0-8. A higher score means a better outcome.

  9. Health-related quality of life of the caregiver: EuroQoL5D (EQ5D) [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    EuroQoL5D (EQ5D). Summary index with a maximum score of 1, including 5 dimensions. A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general health status with a total score range of 0-100. A higher score means a better outcome.

  10. Caregiver burden [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    Zarit Caregiver Burden Index (ZBI). Total score range: 0-88. A lower score means a better outcome.

  11. Caregiver quality of life: CarerQol-7D [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    CarerQol-7D. Total score range: 0-14 (weighted sum score: 0-100). A higher score means a better outcome. In addition, there is a visual analogue scale (VAS) to indicate general well-being with a total score range of 0-10. A higher score means a better outcome.

  12. Skills of proactive coping of the caregiver [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    Utrecht Proactive Coping Competence Scale (UPCC). Total score range: 21-84. A higher score means a better outcome.

  13. Medical consumption of the patient [ Time Frame: Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months ]
    Medical Consumption Questionnaire (MCQ). There is no minimum or maximum score, this scale is a generic instrument for measuring medical costs.

  14. Productivity loss of the patient [ Time Frame: Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months ]
    Productivity Cost Questionnaire (PCQ). There is no minimum or maximum score, this scale is a generic instrument to measure productivity losses related to the disease.

  15. Medical consumption of the caregiver related to providing care to the patient [ Time Frame: Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months ]
    Adjusted version of the Medical Consumption Questionnaire (MCQ). There is no minimum or maximum score, this scale is a generic instrument for measuring medical costs.

  16. Productivity loss of the caregiver related to providing care to the patient [ Time Frame: Baseline, change from baseline at 3 months, 6 months, 9 months, 12 months, 15 months and 18 months ]
    Adjusted version of the Productivity Cost Questionnaire (PCQ). There is no minimum or maximum score, this scale is a generic instrument to measure productivity losses related to being a caregiver.

  17. Nighttime sleep problems and daytime sleepiness [ Time Frame: Baseline, change from baseline at 12 months, change from baseline at 18 months ]
    Scales for Outcomes in Parkinson's disease - Sleep Questionnaire (SCOPA-SLEEP). Total score range: 0-33, including 2 subcategories. Subcategories are summed to compute the total score. A lower score means a better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of idiopathic PD;
  • Sufficient knowledge of the Dutch language to fill out questionnaires;
  • Age 18 years or older at the time of diagnosis;
  • All disease stages, regardless of disease severity or disease duration;
  • Not having received care from a PDNS in the past two years;
  • A score of ≥ 18 on the Mini-Mental State Examination (MMSE13) and ≥ 12 on the Frontal Assessment Battery (FAB14).

Exclusion Criteria:

  • A type of atypical parkinsonism caused by medication (e.g. neuroleptics), a metabolic disorder (e.g. Wilson's disease), encephalitis or a neurodegenerative disorder (e.g. multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome).
  • Residing in a nursing home or another type of residential care facility (because the PDNS is not operational there).
  • Any other medical or psychiatric disorder that, in the opinion of the researcher, may compromise participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830190


Contacts
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Contact: Nienke M de Vries, PhD 003124-3615213 nienke.devries-farrouh@radboudumc.nl
Contact: Danique LM Radder, MD 003124-3655345 danique.radder@radboudumc.nl

Locations
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Netherlands
Radboud University Medical Center, Department of Neurology Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GC
Contact: Nienke M de Vries, PhD    003124-3615213    nienke.devries-farrouh@radboudumc.nl   
Contact: Danique LM Radder, MD    003124-3655345    danique.radder@radboudumc.nl   
Principal Investigator: Bastiaan R Bloem, MD, PhD         
Sub-Investigator: Nienke M de Vries, PhD         
Sub-Investigator: Danique LM Radder, MD         
Sub-Investigator: Herma H Lennaerts, MSc         
Sub-Investigator: Linda ter Brake, MSc         
Sub-Investigator: Marten Munneke, PhD         
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Zambon SpA
Investigators
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Principal Investigator: Bastiaan R Bloem, MD, PhD Department of Neurology, Radboudumc, Nijmegen, The Netherlands.
  Study Documents (Full-Text)

Documents provided by Radboud University:

Additional Information:
Publications:
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03830190     History of Changes
Other Study ID Numbers: NICE-PD
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radboud University:
Parkinson's disease
Parkinson's disease nurse specialist
Nursing
Quality of life
Cost-effectiveness
Multidisciplinary care

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