NCT03830190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 22, 2023

Status Verified

October 1, 2020

Enrollment Period

4.3 years

First QC Date

December 20, 2018

Last Update Submit

November 21, 2023

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseParkinson's disease nurse specialistNursingQuality of lifeCost-effectivenessMultidisciplinary care

Outcome Measures

Primary Outcomes (2)

  • Disease-specific health-related quality of life: Parkinson's disease Questionnaire (PDQ-39)

    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.

    Baseline, change from baseline quality of life at 12 months, change from baseline quality of life at 18 months

  • Motor symptoms

    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.

    Baseline, change from baseline motor symptoms at 12 months, change from baseline motor symptoms at 18 months

Secondary Outcomes (17)

  • Longitudinal Parkinson's disease symptoms

    Baseline, change from baseline Parkinson's disease symptoms at 12 months, change from baseline Parkinson's disease symptoms at 18 months

  • Mobility

    Baseline, change from baseline TUG at 12 months, change from baseline TUG at 18 months

  • Non-motor symptoms (anxiety and depression)

    Baseline, 12 months, 18 months

  • Non-motor symptoms

    Baseline, change from baseline at 12 months, change from baseline at 18 months

  • Health-related quality of life: EuroQoL5D (EQ5D)

    Baseline, change from baseline at 12 months, change from baseline at 18 months

  • +12 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Parkinson's disease nurse specialist care

Other: Parkinson's disease nurse specialist care

Control group

NO INTERVENTION

No intervention

Interventions

Parkinson's disease nurse specialist careOTHER

Specialized nursing care provided by a Parkinson's disease nurse specialist

Also known as: PDNS care
Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center, Department of Neurology

Nijmegen, Gelderland, 6525 GC, Netherlands

Location

Related Publications (5)

  • Lennaerts H, Groot M, Rood B, Gilissen K, Tulp H, van Wensen E, Munneke M, van Laar T, Bloem BR. A Guideline for Parkinson's Disease Nurse Specialists, with Recommendations for Clinical Practice. J Parkinsons Dis. 2017;7(4):749-754. doi: 10.3233/JPD-171195.

    PMID: 28800338BACKGROUND

  • Jahanshahi M, Brown RG, Whitehouse C, Quinn N, Marsden CD. Contact with a nurse practitioner: a short-term evaluation study in Parkinson's disease and dystonia. Behav Neurol. 1994;7(3):189-96. doi: 10.3233/BEN-1994-73-414.

    PMID: 24487336BACKGROUND

  • Reynolds H, Wilson-Barnett J, Richardson G. Evaluation of the role of the Parkinson's disease nurse specialist. Int J Nurs Stud. 2000 Aug;37(4):337-49. doi: 10.1016/s0020-7489(00)00013-4.

    PMID: 10760541BACKGROUND

  • Jarman B, Hurwitz B, Cook A, Bajekal M, Lee A. Effects of community based nurses specialising in Parkinson's disease on health outcome and costs: randomised controlled trial. BMJ. 2002 May 4;324(7345):1072-5. doi: 10.1136/bmj.324.7345.1072.

    PMID: 11991913BACKGROUND

  • Radder DLM, Lennaerts HH, Vermeulen H, van Asseldonk T, Delnooz CCS, Hagen RH, Munneke M, Bloem BR, de Vries NM. The cost-effectiveness of specialized nursing interventions for people with Parkinson's disease: the NICE-PD study protocol for a randomized controlled clinical trial. Trials. 2020 Jan 15;21(1):88. doi: 10.1186/s13063-019-3926-y.

    PMID: 31941538DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Bastiaan R Bloem, MD, PhD

    Department of Neurology, Radboudumc, Nijmegen, The Netherlands.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

February 5, 2019

Study Start

January 7, 2019

Primary Completion

April 30, 2023

Study Completion

October 30, 2023

Last Updated

November 22, 2023

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)