Clinical trial NCT03152721: The Effect of Parkinson Kinetigraph Recordings on the Management and Outcome in Parkinson's Disease
Official title: Interventional Study of the Effect of Parkinson Kinetigraph Recordings on the Clinical Management and Outcome in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: accelerometry
home based
motor complications
Parkinson KinetiGraph
Registry
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomisation to intervention and control group. The effect of providing the objective measurement and self assessment scales compared to only self assessment scales on the management decisions will be evaluated. A secondary outcome is the ability of the measurement to identify sub-optimally treated individuals in comparison with self assessment scales.
Primary purpose: TREATMENT

Brief summary: With time most people with Parkinson's disease (PwP) develop fluctuations in motor symptoms in relation to medication intake. The prevalence may be both under and overestimated as it is based on history rather than observation. Patterns in fluctuations are difficult to determine and it has been demonstrated that every 30-minute diaries need to be kept for 10 days or more to safely represent fluctuation patterns. The Parkinson Kinetigraph (PKG) is an automated system that is carried passively and provides similar information after wearing the device for 6 days. Clinical experience is that most patients agree that results are representative to their experiences. It is not known if using the PKG routinely at any stage of PD will change management of the disease. The hypothesis of this study is that providing PKG information to neurologists will lead to a more active management that may improve outcome in PD patients.

Detailed description: Patients that have previously not performed a PKG recording will be recruited from the WestPORTS community based cohort of outpatients with PD in West Sweden. The WestPORTS study includes self-assessments like PDQ8 and NMS-Q as well as PKG recordings. On inclusion in WestPORTS-Int subjects will be randomized by minimization for age, gender and disease duration into one of two study arms. In the intervention group the PKG recording of the subject will be made available, together with a summarized interpretation, to the subject's regular neurologist/geriatrician before the next scheduled visit/contact. The neurologist will also be provided with PDQ8 and NMS-Q responses. In the control group only PDQ8 and NMS-Q responses will be available to the treating neurologist/geriatrician.

At the next regular visit/contact the physician will fill out an assessment of the state of the patient, whether stable or in need of change in management. Any contraindications to changed management will be noted and the decision to change or not change management will be recorded as the primary outcome of the study. Secondary outcomes are the patient reported experience of outpatient care according to a modified version of the Generic Short Patient Experiences Questionnaire (GS-PEQ), as well as patient reported (PDQ8, NMS-Q, PRO-PD, EQ5D5L) and PKG outcomes at a time point three months later.

Change of management is defined as any of the following:

1. Adding or stopping a dopamine agonist, COMT- or MAO-inhibitor, anticholinergic or amantadine.
2. Fractionation or de-fractionation of the current daily levodopa dose
3. Change of current Levodopa Equivalent daily dose by 15% or more
4. Start or stop of night medication
5. Referral for device assisted therapy (LCIG, apomorphine pump or DBS)

Actual change of management (as opposed to decision to change) will be documented by retrospective review of medical records and prescription records. This will be a secondary measure.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Parkinson's disease (ICD G209) according to medical records
2. A visit to an outpatient neurological or geriatric clinic in the region Vastra Gotaland, Sweden within the last -1 to -7 months according to medical records.
3. Randomized to invitation to participate in the WestPORTS objective measurement Cohort study (NCT03130595) by 1:4 randomization based on the full population fulfilling criteria 1 and 2.
4. Written informed consent
5. No previous PKG recording has been performed with the subject.

Exclusion Criteria:

1. Withdrawal of consent.
2. Unable to wear a PKG on either wrist.
3. The patient's physician is the PI of the study (F Bergquist)

Primary outcomes:
measure: Decision to change management
timeFrame: On first regular contact, RC, (telephone or visit) wich takes place within four months after PKG-recording
Secondary outcomes:
measure: Actual change of management
timeFrame: Change should take place within 4 weeks from the RC.
measure: Patient Reported Experience of Care
timeFrame: The assessment will be made within 3 days from the first RC after PKG-recording,
measure: PRO-PD score at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: PDQ-8 score at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: NMSQ score at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: EQ5D-5L at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: Parkinson Kinetigraph bradykinesia measurement at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: Parkinson Kinetigraph dyskinesia measurement at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: Parkinson Kinetigraph fluctuation score at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: Parkinson Kinetigraph Tremor measurement at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: Parkinson Kinetigraph immobility measurement at 3 months after the first regular visit
timeFrame: The assessment is made 3 months after the RC.
measure: Change in PDQ8 compared to baseline
timeFrame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
measure: Change in NMSQ compared to baseline
timeFrame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
measure: Change in EQ5D5L compared to baseline
timeFrame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
measure: Change in Parkinson Kinetigraph bradykinesia score compared to baseline
timeFrame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
measure: Change in Parkinson Kinetigraph dyskinesia score compared to baseline
timeFrame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
measure: Change in Parkinson Kinetigraph fluctuation score compared to baseline
timeFrame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
measure: Change in Parkinson Kinetigraph Tremor measurement compared to baseline
timeFrame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
measure: Change in Parkinson Kinetigraph Immobility measurement compared to baseline
timeFrame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Filip Bergquist
role: PRINCIPAL_INVESTIGATOR
References: