The 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…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to assess whether a structured medication
review leads to better quality of life in patients with PD. Disease-specific
quality of life will be measured, using the PDQ-39.
Secondary outcome
The secondary objectives of the study are measurements of activities in daily
life and physical disability, non-motor symptoms, cost-effectiveness and health
status, 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 on activities in daily life and the level of physical disability
will be measured, using the ALDS.
- The effects on non-motor symptoms will be measured, using the NMSQuest.
- Cost-effectiveness and the experience of health status will be measured,
using the EQ-5D and the VAS.
- The effects on quality of life for personal or home caregivers of patients
with PD will be measured, using the PDQ carer questionnaire.
- A better insight in the process of performing a medication review will be
obtained from the perspective of community pharmacists, analysing probable
bottlenecks and mapping which method of working is the most sufficient.
Background summary
Parkinson*s Disease (PD) is a progressive, neurodegenerative disease resulting
from degeneration of dopaminergic neurons within the substantia nigra, which
leads to a shortage of dopamine in the striatum. Patients with PD need to take
a variety of anti-Parkinson medications in order to manage the symptoms of the
disease. Next to this, possible other medications might be prescribed due to
comorbidity. Since all these medications need to be taken at different doses
and at different times of a day, this can lead to complicated medication
schedules. Due to these multiple drug regimens, decreased medication adherence
occurs, which means that a considerable amount of patients with PD do not fully
benefit from their medical treatment. A potential intervention to enhance
medication adherence is by performing a structured medication review.
Study objective
The 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.
Study design
The study will be designed as a randomized controlled trial (RCT) with a
follow-up of six months. Half of the randomly assigned patients will receive
the intervention, while the other half will not receive the intervention and
receives usual care. Measurements at baseline will be done before the
intervention. The follow-up measurements will take place after three months and
six months to compare possible differences in outcomes between the intervention
group and the control group.
Intervention
As intervention, community pharmacists will perform the structured medication
reviews 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.
Study burden and risks
The intervention is a useful tool that does not cause a burden for participants
and is not associated with risks. During the study, solely patients with PD in
the intervention group might benefit from the investigation. Patients in the
control group will not receive the intervention and will not benefit.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
* 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 independent or semi-independent in the region of Enschede
* Be able to read and write the Dutch language
Exclusion criteria
* Unable to take own medications, excluding PD patients with personal or family home caregivers
* Received a medication review within a year before the study
* Received a Deep Brain Stimulator within a year before the study
* Receiving continuous duodopa gastro-intestinal gel therapy or will receive this within three months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL48661.044.14 |
| OMON | NL-OMON21486 |