Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Ambulatory monitoring, Disease progression
Brief summary
Background: Long-term management of Parkinson's disease (PD) does not reach its full potential due to lack of knowledge about disease progression. The Real-PD study aim to evaluate the feasibility and compliance of usage of wearable sensors in PD patients in real life. Moreover, an explorative analysis concerning activity level, medication intake and mood will be done. Methods: Overall, 1000 PD patients and 250 physiotherapist will be enrolled in this observational study. Dutch PD patients will be recruited across the country and an assessment will be performed using a short version of the Parkinson's Progression Markers Initiative (PPMI) protocol. Moreover, participants will wear a set of medical devices (Pebble Smartwatch, fall detector) and they will use a smartphone with The Fox Insight App (Android app), 24/7, during 13 weeks. Primary measures of interest are: 1) physical activity, falls and tremor, measured by the axial accelerometers embedded in the Pebble watch and fall detector; and 2) medication intake and mood reports measured by patients' self-report in the Android app. To measure motor impact, an assessment will be performed by physiotherapists who are all certified to perform the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Discussion: Management of PD patients is complex and appears to be a challenging task for health care professionals. The main reason is the lack of knowledge in the disease pattern. This issue could be solved by a long term follow-up of patients' during their everyday life, and wearable medical devices can act as a way to collect data about every day life activities. Therefore, the Real-PD study will be a first contribution in increasing the lack of knowledge in disease progression, developing a new medical decision system and improving PD patients' care.
Detailed description
Rationale: Today's management of patients with a chronic disorder like Parkinson's disease (PD) is imperfect. The understanding of clinical profiles is based on observations in small, selective populations with brief follow-up. Moreover, treatment decisions are based on averaged population results that may not apply to a specific individual context. These drawbacks will be addressed with a big data approach. Ambulatory sensors will be used as an objective measure of patients' performance under everyday circumstances, for longer periods of time. The researchers aim to explore the potential of using longitudinal ambulatory data to enrich a standardized clinical dataset, which reflects current clinical practice for the assessment of disease status. Objective: The study will include a total of 250 physiotherapists and 1000 patients. The aims of this study are: (1) to perform big data analyses on the raw sensor data, in relation to concurrently acquired clinical data in these patients (limited version of the PPMI (Parkinson's Progression Markers Initiative) protocol) to develop patient profiles; and (2) to correlate the ambulatory sensor data to simple self-assessments made during follow-up. Study design: Observational descriptive study. Study population: Dutch Parkinson patients, male or female, age 30 years or older, with PD diagnosis given by a physician, and own a suitable smartphone. lntervention: 250 ParkinsonNet physiotherapists and 1000 eligible patients will be included in this study. Patients and physiotherapists will be recruited in 5 consecutive cohorts based on geographic region. Patients will be asked to wear a smartwatch and a pendant movement sensor, both with triaxial accelerometers, during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling. During the 13 week follow-up, trained physiotherapists will perform a standardized clinical assessment, based on the PPMI protocol (www.ppmi-info.org) for every included patient. This assessment will last for 60 minutes. The smartphone is used to transmit data from the watch to a cloud-based data platform. lntel developed this dedicated data analysis platform for ambulatory data. lntel will receive coded data only. Main study parameters/endpoints: Study endpoints include parameters registered with the smartwatch, the pendant movement sensor, the self-monitoring app and collected with the PPMI assessment. The smartwatch data provides, after data processing, a measure for the level of physical activity during the day. Falls will be registered with the pendant movement sensor. Medication intake and mood are registered using the smartphone. Finally, PPMI assessment includes assessment of motor symptoms, cognition, depression, sleep and daily activity. Correlations will be determined between the above mentioned parameters. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: First, participants are asked to wear the devices 24/7 and data will be recorded continuously, for a total duration of 13 weeks. Second, data will be transmitted to a data platform developed and managed by lntel, on behalf of the Michael J. Fox Foundation for Parkinson's Research. To access these data, researchers can grant permission for research purposes, provided by Michael J. Fox Foundation. Patients will be asked for permission to share the raw coded data for dissemination to the research community, analysis and use in future publications. Participation in the study warrants that patients provide written permission for this.
Interventions
OTHERClinical assessment
During the 13 week follow-up, trained physiotherapists will perform a standardized clinical assessment, based on the PPMI protocol (www.ppmi-info.org) for every included patient. This assessment will last for 60 minutes, and it will be done once.
DEVICEFox Insight self-monitoring android app and falls detector
Patients will be asked to wear a smartwatch and a pendant movement sensor, both with triaxial accelerometers, during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Philips Electronics Nederland B.V. acting through Philips CTO organization
Intel Corporation
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Currently own and use a smartphone device with access to the Internet 2. 30 years of age or older; 3. Diagnosed with Parkinson's disease by a physician; 4. Able to walk without any assistance.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parkinson's Disease Symptoms | Baseline | The MDS-UPDRS is a revision of the Unified Parkinson's Disease Rating Scale (UPDRS). It was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living, as well as motor complications. The MDS-UPDRS characterizes the extent and burden of disease across various populations. Here, we used data from one-point assessment (baseline). The total score used here was calculated by a sum of all scores from the 4 sub-scales (i.e. part I, up to part IV) composing the MDS-UPDRS. Total score ranges from 0 to 272. A higher score indicates higher disease severity and burden, being thus a worse outcome. |
| Depression Scores as a Measure of Depression Rates | Baseline | The scores obtained with the Geriatric Depression Scale were analysed in order to create a percentage of probably depressed participants. The total score goes from 0 to 15. A score higher than 6 indicates higher probability of suffer from a depression. |
| Cognitive Impairment. | Baseline | Total sum score obtained with the Montreal Cognitive Assessment. We analyzed the full score to investigate percentage of participants with a possible cognitive impairment. The Montreal Cognitive sum scores ranges from 0 to 30, in which a score lower or equal to 26 is considered as possible cognitive decline. |
| Independency Level | Baseline | The total sum score obtained with the Schwab and England activities of daily living scale were analyzed to describe the functional level of the sample. The total sum scores varies from 0 to 100, in which lower scores are associated with more dependency of others to perform daily life activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Activity for Each Patient During the Day | Patients will be automatically assessed during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week. | The level of activity for each patient is calculated automatically through the app at the smartphone. The calculation is performed by using the data collect with the accelerometers embedded in the smartwatch. An algorithm installed in the phone, which analyze the data collected with the smartwatch, can calculate the level of activity for each patient throughout the day. |
| Number of Falls Per Patient Registered by the Falls Detector. | Patients will be automatically assessed during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week. | The fall event is recognized by the falls detector. Every time that the patient falls, the algorithm embedded at the falls detector recognize as a fall and record the fall event. At the end of the follow-up time, a sum of the falls event for each patient will be done. |
| Sleepiness Rates in the Epworth Sleepiness Scale as a Measure of Sleep Quantity. | Baseline | The Epworth sleepiness scale was used to rate the level of sleepiness during the day. The scale's scores are related to the usual duration of sleep at night and increase with relative sleep deprivation. Here, we used data from one-point assessment (baseline). Then, we can suggest that if the sample has high scores they will have a low sleep quantity. Total sum score ranges from 0 (no sleepiness at all) to 24 (excessive sleepiness). |
| Scores in Autonomic Dysfunctions Measure With the Autonomic Dysfunctions Scale | Baseline | The scores for autonomic dysfunctions will be obtained with the Assessment of autonomic dysfunction in Parkinson's disease (SCOPA-AUT). The total sum scores ranges from 0 to 100, in which high scores are correlated with more burden of autonomic dysfunctions in Parkinson's patients. |
| Number of Mood Reports for Each Patient Measured With a Four Point Scale | Patients will be assessed during the follow-up time (up to 13 weeks after the enrollment date). It is expected that the assessment (self-report) will be performed as many times as the patient wants to report how they feel or at least once a day. | The number of mood reports will be collected through the smartphone application. A four point scale (very good, good, poor and fair) will be available, and by pressing the button which correspond to how the patient feels at that moment the report can be performed. At the end of the follow-up time a sum of all the reports will be done in order to measure the number of mood reports over the follow-up time. |
| Number of Medication Intake Annotations Made by Each Participant Via the Self-report App. | Baseline | The number of medication intake annotations made by the patients will be collected through the smartphone application. Every time that the patient take medication they must press the button reporting that they took the medication. At the end of the follow-up time a sum of all the reports will be done in order to measure the number of medication intake over the follow-up time. |
| Time That Each Patient Was Active During the Day | Patients will be automatically assessed continuously during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week. The analyses was limited to walking activities. | The time that the patient was active during the day is calculated automatically through the app at the smartphone. The calculation is performed by using an algorithm, which analyze the patterns of walk. This algorithm is able to predict when the patient was active in a zone above his/her usual threshold (e.g. when the patient was performing one activity that makes him/her more active than during a quiet time). At the end of the follow-up time a sum of all active hours will be done in order to measure the amount of time that the patient was active over the follow-up time. |
Countries
Netherlands
Participant flow
Pre-assignment details
After changing the inclusion process for one cohort only, a total of 347 eligible PD patients were invited to participate. Among those invited, 43 refused to participate. The main refusal reasons were Study protocol seems too burdensome (44%, n = 19), followed by Personal circumstances (33%, n = 14). A total of 304 patients (enrolment rate = 88%) were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Dutch Parkinson's patients who fulfill the eligibility criteria.
Interventions/Exposures to be administered:
1. PPMI (Parkinson's Progression Markers Initiative) protocol Trained physiotherapists will perform once a standardized clinical assessment to every included patient. This assessment will last for 60 minutes, and it will be done once.
2. Fox Insight self-monitoring android app and falls detector Patients will wear a smartwatch and a pendant movement sensor during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling. | 291 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdraw or did not contribute data. | 13 |
Baseline characteristics
| Characteristic | — | Cohort 1 |
|---|---|---|
| Age at disease onset. | — years | — |
| Age, Categorical <=18 years | — | 0 Participants |
| Age, Categorical >=65 years | — | 261 Participants |
| Age, Categorical Between 18 and 65 years | — | 30 Participants |
| Cognitive impairment No | — | 124 Participants |
| Cognitive impairment Yes | — | 167 Participants |
| Depression No | — | 238 Participants |
| Depression Yes | — | 53 Participants |
| Disease severity Missing | — | 51 Participants |
| Disease severity Stage 0 or 1 | — | 73 Participants |
| Disease severity Stage 2 | — | 127 Participants |
| Disease severity Stage 3 | — | 34 Participants |
| Disease severity Stage 4 or 5 | — | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | — | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | — | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | — | 291 Participants |
| Independency level 71-80 | — | 51 participants |
| Independency level 81-90 | — | 110 participants |
| Independency level Equal or higher to 91 | — | 41 participants |
| Independency level Equal or small to 70 | — | 36 participants |
| Level of education High | — | 101 Participants |
| Level of education Low | — | 51 Participants |
| Level of education Middel | — | 103 Participants |
| Level of education Missing | — | 36 Participants |
| MDS-UPDRS | — | 52.5 units on a scale |
| Sex: Female, Male Female | — | 123 Participants |
| Sex: Female, Male Male | — | 168 Participants |
| Time since Diagnose | — years | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 291 |
| serious Total, serious adverse events | 0 / 291 |
Outcome results
Primary
Cognitive Impairment.
Total sum score obtained with the Montreal Cognitive Assessment. We analyzed the full score to investigate percentage of participants with a possible cognitive impairment. The Montreal Cognitive sum scores ranges from 0 to 30, in which a score lower or equal to 26 is considered as possible cognitive decline.
Time frame: Baseline
Population: We analyzed all participants who completed the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Cognitive Impairment. | No cognitive decline | 125 Participants |
| Cohort 1 | Cognitive Impairment. | Possible cognitive decline | 166 Participants |
Primary
Depression Scores as a Measure of Depression Rates
The scores obtained with the Geriatric Depression Scale were analysed in order to create a percentage of probably depressed participants. The total score goes from 0 to 15. A score higher than 6 indicates higher probability of suffer from a depression.
Time frame: Baseline
Population: We have analyzed all participants who completed the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Depression Scores as a Measure of Depression Rates | No | 238 Participants |
| Cohort 1 | Depression Scores as a Measure of Depression Rates | Yes | 53 Participants |
Primary
Independency Level
The total sum score obtained with the Schwab and England activities of daily living scale were analyzed to describe the functional level of the sample. The total sum scores varies from 0 to 100, in which lower scores are associated with more dependency of others to perform daily life activities.
Time frame: Baseline
Population: We analyzed all participants who completed the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 | Independency Level | Lower or equal to 70 | 36 Participants |
| Cohort 1 | Independency Level | Higher than 70 and lower than 81 | 51 Participants |
| Cohort 1 | Independency Level | Higher than 80 and lower than 91 | 109 Participants |
| Cohort 1 | Independency Level | higher than 90 | 41 Participants |
| Cohort 1 | Independency Level | Missing | 54 Participants |
Primary
Parkinson's Disease Symptoms
The MDS-UPDRS is a revision of the Unified Parkinson's Disease Rating Scale (UPDRS). It was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living, as well as motor complications. The MDS-UPDRS characterizes the extent and burden of disease across various populations. Here, we used data from one-point assessment (baseline). The total score used here was calculated by a sum of all scores from the 4 sub-scales (i.e. part I, up to part IV) composing the MDS-UPDRS. Total score ranges from 0 to 272. A higher score indicates higher disease severity and burden, being thus a worse outcome.
Time frame: Baseline
Population: We have analysed data from all participants who completed the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 | Parkinson's Disease Symptoms | 52.5 units on a scale |
Secondary
Level of Activity for Each Patient During the Day
The level of activity for each patient is calculated automatically through the app at the smartphone. The calculation is performed by using the data collect with the accelerometers embedded in the smartwatch. An algorithm installed in the phone, which analyze the data collected with the smartwatch, can calculate the level of activity for each patient throughout the day.
Time frame: Patients will be automatically assessed during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week.
Population: The collected accelerometer data turned out to be unsuitable to calculate the level of activity during the day. Algorithms produced unreliable information on activity levels and therefore no data on this outcome measure were available.
Secondary
Number of Falls Per Patient Registered by the Falls Detector.
The fall event is recognized by the falls detector. Every time that the patient falls, the algorithm embedded at the falls detector recognize as a fall and record the fall event. At the end of the follow-up time, a sum of the falls event for each patient will be done.
Time frame: Patients will be automatically assessed during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week.
Population: We invited 43 study participants to wear the fall detector, of whom 13 consented to wear it. Unfortunately the quality of the collected data did not allow for automated falls detection. Therefore we couldn't determine this outcome measure.
Secondary
Number of Medication Intake Annotations Made by Each Participant Via the Self-report App.
The number of medication intake annotations made by the patients will be collected through the smartphone application. Every time that the patient take medication they must press the button reporting that they took the medication. At the end of the follow-up time a sum of all the reports will be done in order to measure the number of medication intake over the follow-up time.
Time frame: Baseline
Population: 96% (n = 280) of data-contributors reported their medication through the app.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Number of Medication Intake Annotations Made by Each Participant Via the Self-report App. | 351 number of annotations | Standard Error 217 |
Secondary
Number of Mood Reports for Each Patient Measured With a Four Point Scale
The number of mood reports will be collected through the smartphone application. A four point scale (very good, good, poor and fair) will be available, and by pressing the button which correspond to how the patient feels at that moment the report can be performed. At the end of the follow-up time a sum of all the reports will be done in order to measure the number of mood reports over the follow-up time.
Time frame: Patients will be assessed during the follow-up time (up to 13 weeks after the enrollment date). It is expected that the assessment (self-report) will be performed as many times as the patient wants to report how they feel or at least once a day.
Population: Though the smartphone application had to option to report mood, participants hardly used this feature. Therefore there were no data collection that were suitable for analysis.
Secondary
Scores in Autonomic Dysfunctions Measure With the Autonomic Dysfunctions Scale
The scores for autonomic dysfunctions will be obtained with the Assessment of autonomic dysfunction in Parkinson's disease (SCOPA-AUT). The total sum scores ranges from 0 to 100, in which high scores are correlated with more burden of autonomic dysfunctions in Parkinson's patients.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Scores in Autonomic Dysfunctions Measure With the Autonomic Dysfunctions Scale | 17.2 score on a scale | Standard Deviation 7.9 |
Secondary
Sleepiness Rates in the Epworth Sleepiness Scale as a Measure of Sleep Quantity.
The Epworth sleepiness scale was used to rate the level of sleepiness during the day. The scale's scores are related to the usual duration of sleep at night and increase with relative sleep deprivation. Here, we used data from one-point assessment (baseline). Then, we can suggest that if the sample has high scores they will have a low sleep quantity. Total sum score ranges from 0 (no sleepiness at all) to 24 (excessive sleepiness).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Sleepiness Rates in the Epworth Sleepiness Scale as a Measure of Sleep Quantity. | 6.0 score on a scale | Standard Deviation 4.7 |
Secondary
Time That Each Patient Was Active During the Day
The time that the patient was active during the day is calculated automatically through the app at the smartphone. The calculation is performed by using an algorithm, which analyze the patterns of walk. This algorithm is able to predict when the patient was active in a zone above his/her usual threshold (e.g. when the patient was performing one activity that makes him/her more active than during a quiet time). At the end of the follow-up time a sum of all active hours will be done in order to measure the amount of time that the patient was active over the follow-up time.
Time frame: Patients will be automatically assessed continuously during the follow-up time (up to 13 weeks after the enrollment date), 24 hours a day, 7 days a week. The analyses was limited to walking activities.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 | Time That Each Patient Was Active During the Day | 72 minutes per day | Standard Deviation 39 |