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

NCT03152721 | Completed

• 2 other identifiers: WestPORTSinterventionPARKreg
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

accelerometry; home based; motor complications; Parkinson KinetiGraph; Registry

Outcome Measures

Primary Outcomes (1)

• 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: 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)

  On first regular contact, RC, (telephone or visit) wich takes place within four months after PKG-recording

Secondary Outcomes (19)

• Actual change of management

  Change should take place within 4 weeks from the RC.

• Patient Reported Experience of Care

  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 assessment is made 3 months after the RC.

• PDQ-8 score at 3 months after the first regular visit

  The assessment is made 3 months after the RC.

• NMSQ score at 3 months after the first regular visit

  The assessment is made 3 months after the RC.

Study Arms (2)

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

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

Device: Parkinson KinetiGraph; Other: Self assessment

Interventions

Parkinson KinetiGraph 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.

Also known as: Parkinson KinetiGraph Mk II, PKG

Intervention

Self assessment 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.

Also known as: PDQ8, NMS-Questionnaire

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Diagnostic Self Evaluation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Filip Bergquist

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient not aware of which information has been provided to his/her physician. Post data collection the groups will be assigned coded group names so that the conditions are masked to the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 15, 2017
• Study Start: April 30, 2017
• Primary Completion: October 1, 2018
• Study Completion: February 28, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

SE (1)