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van CCT (UK)

van CCT (UK)

Medication review in Parkinson

- candidate number16897
- NTR NumberNTR4500
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2014
- Secondary IDsNL48661.044.14 METC Twente
- Public TitleMedication review in Parkinson
- Scientific TitleA Study Assessing The Effect Of A Structured Medication Review On Quality Of Life In Patients With Parkinson’s Disease
- ACRONYMMedication review in Parkinson
- hypothesisThe expectation is that a structured medication review in primary care improves medication adherence and leads to positive patient outcomes in patients with Parkinson's Disease
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Compliance, Drug trials, Polypharmacy
- Inclusion criteriaThe patient has/is:
• Diagnosed with PD according to the UK-brain banking criteria
• ≥ Eighteen years of age
• ≥ Four different medications daily
• ≥ Four medication intake moments daily
• Expressing motor symptoms or non-motor symptoms
• Living (semi)-independent in the region of Enschede
• Able to read and write the Dutch language
- Exclusion criteriaThe patient has/is:
• Unable to administrate own medications, excluding PD patients with personal or family home caregivers
• Received a medication review within a year before the study
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2014
- planned closingdate1-mei-2015
- Target number of participants198
- InterventionsThe study is a prospective randomized, controlled trial (RCT).
As intervention, community pharmacists perform a structured medication review as one-time assessment at the start of the study within the intervention group. Measurements at baseline will be done before the intervention. The follow-up measurements will take place after three months and six months.
A structured medication review can be defined as ‘a structured, critical examination of a patient’s medicines with the objective of reaching an agreement with the patient about treatment, optimizing the impact of medicines, minimizing the number of medication-related problems and reducing waste’
- Primary outcomeThe primary objective of the study is to assess whether a structured medication review improves medication adherence and leads to better quality of life in patients with PD after a follow-up of three months and six months, compared to patients with PD who will not receive a structured medication review during follow-up. Disease-specific quality of life will be measured, using the Parkinson’s Disease Questionnaire-39 (PDQ-39).
- Secondary outcomeThe secondary objectives of the study are measurements of activities in daily life and physical disability, mobility and motor symptoms, non-motor symptoms, cost-effectiveness and health state, and personal carers’ quality of life, by comparing the results of PD patients who receive a medication review with PD patients who will not receive a medication review. The effects will be measured by using the AMC Linear Disability Scale (ALDS), the Non Motor Symptoms Questionnaire (NMSQuest), the EuroQOL-5 Dimensions (EQ-5D), the Visual Analogue Scale (VAS), and the PDQ carer questionnaire.
- Timepoints- Baseline
- Three months
- Six months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. J. Palen, van der
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente, Enschede
- Publications
- Brief summaryThe aim of this study is to assess whether a structured medication review in primary care improves medication adherence and leads to positive patient outcomes in patients with PD. The expectation is that the results of this study might be used to improve daily treatment of patients with PD.
- Main changes (audit trail)
- RECORD17-mrt-2014 - 29-apr-2014

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