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Medido.

Comparison of using the Medido medication dispenser versus care as usual on physical disabilities on patients with Parkinson’s disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22331
Enrollment
100
Registered
2013-03-19
Start date
2013-04-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease Therapy adherence Medication Ziekte van Parkinson Therapietrouw Medicatie

Interventions

This study is a prospective randomized controlled trial (RCT) with a follow up of 3 months. The interventions, Medido versus usual care, are randomly assigned to the patients and will be stratified by
possibly a capsule will be used. Changes in medication use during the study are passed on to the pharmacist, which is regular care. Subsequently, the baxtered medication can be changed. When is it nee

Sponsors

Mw. L. ter Brake-Berning, nurse practitioner Parkinson en Mw L. Vree Egberts, researcher
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patient: 1. Is older than forty years; 2. Has four or more medication intake moments a day, including non-parkinson medication; 3. Has on-off fluctuations when Parkinson medication is not taken; 4. Has given consent to participate in the study; 5. Is diagnosed with Parkinson’s disease; 6. Will be treated at Medisch Spectrum Twente at Enschede or ZiekenhuisGroep Twente at Hengelo or Almelo; 7. May receive personal at-home care.

Exclusion criteria

Exclusion criteria: Patients: 1. Not capable of completing the questionnaires; 2. Whose medication is administered by other persons, excluding patients with personal at-home care givers.

Design outcomes

Primary

MeasureTime frame
The primary parameter of this study is the physical disability of Parkinson’s patients. To measure the physical disability, the AMC Linear Disability Score (ALDS) will be used. The ALDS checks the activities in daily life of the patient. The ALDS is a flexible, validated and clinimetrically sound and flexible instrument to assess the level of disability in patients with Parkinson’s disease.

Secondary

MeasureTime frame
1. Does the use of Medido improve the Quality of life of Parkinson’s patients compared with the current method of medication distribution to Parkinson’s patients after a follow-up period of 3 months, as measured by the PDQ39 questionnaire; 2. 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); 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 patient experience of motor symptoms in the Medido group versus regular care group, as measured by the Visual Analog Scale (VAS); 5. How many times do you have a off-period during the day, as measured by the MDS-UPDRS.

Contacts

Public ContactJ. Palen, van der

Medisch Spectrum Twente, P.O. Box 50000

+31 (0)53 4872023

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)