Parkinson DiseaseNCT03152721
The Effect of Parkinson Kinetigraph Recordings on the Management and Outcome in Parkinson's Disease
A study testing Parkinson KinetiGraph and Self assessment in people with Parkinson Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Parkinson KinetiGraph and Self assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteSweden
- Study dates
- 30 Apr 2017to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's disease (ICD G209) according to medical records
- 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.
- 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.
- Written informed consent
- No previous PKG recording has been performed with the subject.
Who cannot join
- Withdrawal of consent.
- Unable to wear a PKG on either wrist.
- The patient's physician is the PI of the study (F Bergquist)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Study of the Effect of Parkinson Kinetigraph Recordings on the Clinical Management and Outcome in Parkinson's Disease
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.
Read the 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:
- Adding or stopping a dopamine agonist, COMT- or MAO-inhibitor, anticholinergic or amantadine.
- Fractionation or de-fractionation of the current daily levodopa dose
- Change of current Levodopa Equivalent daily dose by 15% or more
- Start or stop of night medication
- 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.
- Conditions
- Parkinson Disease
- Being tested
- Parkinson KinetiGraph, Self assessment
- Keywords
- accelerometry, home based, motor complications, Parkinson KinetiGraph, Registry
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parkinson KinetiGraphDevice
Also called Parkinson KinetiGraph Mk II, PKG
The Parkinson Kinetigraph (PKG) is a wrist-worn accelerometer shaped as a watch. It records spontaneous movements and for every two minutes provides a bradykinesia score and a dyskinesia score. Furthermore it analysis movement for tremor-like episodes and registers the time with tremulous movements as well as time with extreme immobility suggesting sleep. The device can be programmed with drug intake times and provide a reminder signal. Intake of drug can be indicated on the device.
Self assessmentOther
Also called PDQ8, NMS-Questionnaire
Administration of self assessment questionnaires are made within 2 weeks from starting a PKG recording. The assessments are Parkinson Disease Quality of life 8 question short version and the Non Motor Symptom in Parkinson Disease Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Treating physician will in advance of upcoming visit be provided with the self assessment scales PDQ8 and NMS-Questionnaire to aid clinical assessment Receives: Other: Self assessment |
| Intervention | Experimental | Treating physician will in advance of upcoming visit be provided with a Parkinson KinetiGraph recording report and interpretation in addition to the self assessment scales PDQ8 and NMS-Questionnaire to aid clinical assessment Receives: Device: Parkinson KinetiGraph; Other: Self assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision to change management
The decision to change management of Parkinson's disease as reported by the treating physician.
Change of management is defined as any of the following:
- Adding or stopping a dopamine agonist, COMT- or MAO-inhibitor, anticholinergic or amantadine.
- Fractionation or de-fractionation of the current daily levodopa dose
- Change of current Levodopa Equivalent daily dose by 15% or more
- Start or stop of night medication
- Referral for device assisted therapy (LCIG, apomorphine pump or DBS)
Measured: On first regular contact, RC, (telephone or visit) wich takes place within four months after PKG-recording
Secondary outcomes (19)
Actual change of management
A retrospectively verified (medical and prescription records) change in management of PD as defined in the primary variable
Measured: Change should take place within 4 weeks from the RC.
Patient Reported Experience of Care
A modified version of Generic Short Patient Experiences Questionnaire (GS-PEQ), Sjetne et al 2011 will be used. The modified questionnaire has 13 questions that are answered with a 5 grade Likert scale and a 5 grade Likert scale describing the importance of each question. Items will be analyzed separately as well as as summary scores
Measured: The assessment will be made within 3 days from the first RC after PKG-recording,
PRO-PD score at 3 months after the first regular visit
The Patient Reported Outcome in PD web questionnaire will be reported as summary score as well as per symptom domain.
Measured: The assessment is made 3 months after the RC.
PDQ-8 score at 3 months after the first regular visit
The 8 question version of Parkinson Disease Quality of Life Questionnaire. Reported as index score (0-100%)
Measured: The assessment is made 3 months after the RC.
NMSQ score at 3 months after the first regular visit
The Non Motor Symptoms Questionnaire will be administered and the number of reported symptoms within the last month are reported
Measured: The assessment is made 3 months after the RC.
EQ5D-5L at 3 months after the first regular visit
The EuroQoL 5 dimension 5 level scale of generic health
Measured: The assessment is made 3 months after the RC.
Parkinson Kinetigraph bradykinesia measurement at 3 months after the first regular visit
Median BK score of a 6 day recording.
Measured: The assessment is made 3 months after the RC.
Parkinson Kinetigraph dyskinesia measurement at 3 months after the first regular visit
Median DK score of a 6 day recording.
Measured: The assessment is made 3 months after the RC.
Parkinson Kinetigraph fluctuation score at 3 months after the first regular visit
Fluctuation dyskinesia score (FDS) of a 6 day recording.
Measured: The assessment is made 3 months after the RC.
Parkinson Kinetigraph Tremor measurement at 3 months after the first regular visit
Mean percent day-time (9-18) tremor time in a 6 day recording.
Measured: The assessment is made 3 months after the RC.
Parkinson Kinetigraph immobility measurement at 3 months after the first regular visit
Mean percent day-time (9-18) immobility time in a 6 day recording.
Measured: The assessment is made 3 months after the RC.
Change in PDQ8 compared to baseline
The change in PDQ8 index score compared to the baseline assessment that is made at the inclusion visit
Measured: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in NMSQ compared to baseline
The change in number of reported non-motor symptoms characterized as improvement, no change, or deterioration compared to the baseline assessment that is made at the inclusion visit
Measured: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in EQ5D5L compared to baseline
The change in index score characterized as improvement, no change, or deterioration compared to the baseline assessment that is made at the inclusion visit
Measured: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph bradykinesia score compared to baseline
The change in BK score characterized as improvement, no change, or deterioration compared to the baseline assessment that is made at the inclusion visit. Improvement defined as abnormal score that has changed to within normal limits, no change defined as normal score that remains within normal limits and deterioration defined as normal score that changes to a score outside normal limits
Measured: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph dyskinesia score compared to baseline
The change in DK score characterized as improvement, no change, or deterioration compared to the baseline assessment that is made at the inclusion visit. Improvement defined as abnormal score that has changed to within normal limits, no change defined as normal score that remains within normal limits and deterioration defined as normal score that changes to a score outside normal limits
Measured: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph fluctuation score compared to baseline
The change in FDS score characterized as improvement, no change, or deterioration compared to the baseline assessment that is made at the inclusion visit. Improvement defined as abnormal score that has changed to within normal limits, no change defined as normal score that remains within normal limits and deterioration defined as normal score that changes to a score outside normal limits
Measured: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph Tremor measurement compared to baseline
The change in percent tremor time characterized as improvement, no change, or deterioration compared to the baseline assessment that is made at the inclusion visit. Improvement defined as a decrease in tremor time which was higher than 0.9% at baseline, no change defined as tremor time that remains lower or equal to 0.9% or remains the same as at baseline. Deterioration defined as an increase in tremor time that results in a tremor time higher than 0.9% at follow up.
Measured: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph Immobility measurement compared to baseline
The change in percent immobility time characterized as improvement, no change, or deterioration compared to the baseline assessment that is made at the inclusion visit. Improvement is defined as a decrease in immobility time, no change is defined as immobility time that remains the same as at baseline. Deterioration defined as an increase in immobility time at follow up.
Measured: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start30 Apr 2017
- Primary completion1 Oct 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Bergquist, Sahlgrenska University Hospital
- Investigators
- Filip Bergquist, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152721
- Sponsor's protocol ID
- WestPORTSintervention
- Other IDs
- PARKreg
- Status last verified
- Apr 2019
- First submitted
- 10 May 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study of the Effect of Parkinson Kinetigraph Recordings on the Clinical Management and Outcome in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03152721
- Acronym / sponsor ID
- WestPORTSintervention
- Conditions
- Parkinson Disease
- Keywords
- accelerometry, home based, motor complications, Parkinson KinetiGraph, Registry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Adding or stopping a dopamine agonist, COMT- or MAO-inhibitor, anticholinergic or amantadine.
- Fractionation or de-fractionation of the current daily levodopa dose
- Change of current Levodopa Equivalent daily dose by 15% or more
- Start or stop of night medication
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Self assessmentTreating physician will in advance of upcoming visit be provided with the self assessment scales PDQ8 and NMS-Questionnaire to aid clinical assessment |
| Intervention | Experimental | Device: Parkinson KinetiGraph, Other: Self assessmentTreating physician will in advance of upcoming visit be provided with a Parkinson KinetiGraph recording report and interpretation in addition to the self assessment scales PDQ8 and NMS-Questionnaire to aid clinical assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Parkinson's disease (ICD G209) according to medical records
- 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.
- 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.
- Written informed consent
- No previous PKG recording has been performed with the subject.
Key exclusion criteria (3 listed)
- Withdrawal of consent.
- Unable to wear a PKG on either wrist.
- The patient's physician is the PI of the study (F Bergquist)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parkinson KinetiGraphAlso: Parkinson KinetiGraph Mk II, PKGThe Parkinson Kinetigraph (PKG) is a wrist-worn accelerometer shaped as a watch. It records spontaneous movements and for every two minutes provides a bradykinesia score and a dyskinesia score. Furthermore it analysis movement for tremor-like episodes and registers the time with tremulous movements as well as time with extreme immobility suggesting sleep. The device can be programmed with drug intake times and provide a reminder signal. Intake of drug can be indicated on the device. | Device | Intervention |
| Self assessmentAlso: PDQ8, NMS-QuestionnaireAdministration of self assessment questionnaires are made within 2 weeks from starting a PKG recording. The assessments are Parkinson Disease Quality of life 8 question short version and the Non Motor Symptom in Parkinson Disease Questionnaire. | Other | Control, Intervention |
Primary outcome
Decision to change management
Time frame: On first regular contact, RC, (telephone or visit) wich takes place within four months after PKG-recording
The decision to change management of Parkinson's disease as reported by the treating physician. 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)
19 secondary outcomes
Actual change of management
Time frame: Change should take place within 4 weeks from the RC.
Patient Reported Experience of Care
Time frame: The assessment will be made within 3 days from the first RC after PKG-recording,
PRO-PD score at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
PDQ-8 score at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
NMSQ score at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
EQ5D-5L at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
Parkinson Kinetigraph bradykinesia measurement at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
Parkinson Kinetigraph dyskinesia measurement at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
Parkinson Kinetigraph fluctuation score at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
Parkinson Kinetigraph Tremor measurement at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
Parkinson Kinetigraph immobility measurement at 3 months after the first regular visit
Time frame: The assessment is made 3 months after the RC.
Change in PDQ8 compared to baseline
Time frame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in NMSQ compared to baseline
Time frame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in EQ5D5L compared to baseline
Time frame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph bradykinesia score compared to baseline
Time frame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph dyskinesia score compared to baseline
Time frame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph fluctuation score compared to baseline
Time frame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph Tremor measurement compared to baseline
Time frame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Change in Parkinson Kinetigraph Immobility measurement compared to baseline
Time frame: Assessed 3 months after the RC and at end of study 12 months after inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Bergquist principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parkinson KinetiGraph and Self assessment in people with Parkinson Disease, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision to change management (time frame: On first regular contact, RC, (telephone or visit) wich takes place within four months after PKG-recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.