The primary objective of the research is to compare the physical disabilities of Parkinson*s patients using the Medido compared to patients taking their medication in the usual way. The secondary objectives are to compare for Medido versus regular…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Does the use of Medido improve the physical disabilities of Parkinson*s
patients compared with the current method of medication distribution to
Parkinson*s patients after a follow-up period of 6 months, as measured by the
ALDS questionnaire?
Secondary outcome
1. What is the cost effectiveness ratio expressed in Cost per QALY of the
Medido for Parkinson*s patients relative to current treatment for Parkinson*s
patients, as measured by the Euroqol 5D (EQ5D)?
2. What is the Quality of life in the Medido groep versus regular care group,
as measured by the PDQ-39?
3. What is the Quality of life for personal care givers for Parkinson*s
patients for care givers in the Medido group versus regular care group, as
measured by the PDQ carer questionnaire?
4. What is the level of physical disability for patients in the Medido group
versus regular care group, as measured by the AMC Linear Disability Score
(ALDS)?
5. What is the patient experience of motor symptoms in the Medido group versus
regular care group, as measured by the Visual Analog Scale (VAS)?
6. How many times do you have a off-period during the day, as measured by the
MDS-UPDRS?
Background summary
Parkinson*s disease is a progressive neuro degenerative disease resulting from
loss of Dopamine producing neurons in substantia nigra. It is necessary that
patients with Parkinson*s disease, who have difficulty with accurately taking
medication, get help from contemporary technology. The expectation is that the
use of Medido is a substantial improvement in the treatment and that the
quality of life will increase. Also the cost effectiveness of Medido will be
taken into account.
Study objective
The primary objective of the research is to compare the physical disabilities
of Parkinson*s patients using the Medido compared to patients taking their
medication in the usual way. The secondary objectives are to compare for Medido
versus regular care the cost effectiveness, Qualiti of life and Quality of life
of the personal care giver. Also the physical disability and the experience of
motor symptoms will be compared for the Medido versus regular care.
Study design
This study is a prospective randomized controlled trial (RCT) with a follow up
of 3 and six months. The interventions, Medido versus usual care, are randomly
assigned to the patients. Measurements will take place at baseline, and after
three and six months. At the end of the study it will be determined if there is
a significant difference between the physical disabilities of the two groups of
patients.
Intervention
The intervention is for six months. One group will use the Medido and one group
will use care as usual.
Study burden and risks
Only patients in the intervention group will in all likelihood benefit from the
study. Those in the control group will not benefit. The risk for adverse events
in this study is negligible. Only Parkinson*s disease patients will have
Parkinson*s disease medication, therefore the study needs to be performed in
this group.
Lulofsstraat 55
Den Haag 2521AL
NL
Lulofsstraat 55
Den Haag 2521AL
NL
Listed location countries
Age
Inclusion criteria
- is older than forty years
- has four or more medication intake moments a day
- has given consent to participate in the study
- is diagnosed with Parkinson*s disease
- will be treated at Medisch Spectrum Twente at Enschede or ZiekenhuisGroep Twente at Hengelo or Almelo.
- may receive personal at-home care
Exclusion criteria
- not capable of completing the questionnaires
- whose medication is administered by other persons, excluding patients with personal at-home care givers
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 | NL43868.044.13 |
| Other | NTR, nummer volgt |
| OMON | NL-OMON22331 |