The Effect of Parkinson Kinetigraph Recordings on the Management and Outcome in Parkinson's Disease

NCT ID: NCT03152721

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2019-02-28

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Treating physician will in advance of upcoming visit be provided with the self assessment scales PDQ8 and NMS-Questionnaire to aid clinical assessment

Group Type: PLACEBO_COMPARATOR

Self assessment

Intervention Type: OTHER

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.

Intervention

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

Group Type: EXPERIMENTAL

Parkinson KinetiGraph

Intervention Type: DEVICE

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 assessment

Intervention Type: OTHER

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.

Interventions

Parkinson KinetiGraph

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.

Intervention Type: DEVICE

Self assessment

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.

Intervention Type: OTHER

Other Intervention Names

Parkinson KinetiGraph Mk II; PKG; PDQ8; NMS-Questionnaire

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Filip Bergquist

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filip Bergquist

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

PARKreg

Identifier Type: REGISTRY

Identifier Source: secondary_id

WestPORTSintervention

Identifier Type: -

Identifier Source: org_study_id