Parkinson DiseaseRETRO-PDNCT04675853
Rapid dEvice Testing pROtocol for Parkinson's Disease
An observational study of Parkinson Disease and Healthy, run by HealthMode Inc. at 1 site in United States.
Trial summary
This is an 8 week observational study to evaluate the feasibility of using remote monitoring technologies in future studies of PD. The study will 2 clinical evaluations (one initial, one final), and an 8-week monitoring period including 4 virtual visits where participants will use a combination of digital devices… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease, Healthy
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to 25 Nov 2021
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll at least 25 dyads consisting of participants with PD and their care partners recruited from multiple clinical practices and the general public. Participants who withdraw from the study before completing virtual visit V04 (day 28) will be replaced. Enrollment will be enriched to ensure that participants are distributed across mild to severe PD.
Who may be able to join
- Participants with PD
- At least 30 years of age
- Clinical diagnosis of PD by a neurologist or other movement disorder specialist as reported by the participant, with current motor symptoms
- Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)
- Have a BMI of 33 or below calculated by participant reported height and weight at the time of screening
- Have a care partner who meets the study's inclusion criteria
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- Able to read, understand, and provide written informed consent in English
- Able, either alone or with a care partner, to operate digital devices
- Have reliable wifi in their home and the ability to connect new devices to their home wifi
- Care partners
- At least 18 years of age
- Able to read, understand, and provide written informed consent in English
- Able to operate digital devices
- Care partner for the participant with PD enrolled in the study
- Lives with the participant with PD enrolled in the study
- Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)
- Willing to exclude pet from the participant's bedroom at night for the duration of the study
Who cannot join
- Participants with PD
- Any non-PD forms of Parkinsonism
- Active psychiatric disorders that affect the ability to complete study tasks
- Any other medical condition that is the primary cause of the present movement disorder
- Cognitive dysfunction (score > 7 on the Six-Item Cognitive Impairment Test)
- Considered by the investigator to be an unsuitable participant
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- Live in a household with more than three people
- Unwilling to exclude pet from their bedroom at night for the duration of the study
- Care partners
- Cognitive dysfunction (score > 7 on the Six-Item Cognitive Impairment Test)
- Considered by the investigator to be an unsuitable participant
Trial locations and contacts
1 site in 1 country.
United States1 site
Mobile Clinical Research Site
New York, New York, 10001
About this study
Official title: Rapid dEvice Testing pROtocol for Parkinson's Disease (RETRO-PD)
This is an 8 week observational study to evaluate the feasibility of using remote monitoring technologies in future studies of PD. The study will 2 clinical evaluations (one initial, one final), and an 8-week monitoring period including 4 virtual visits where participants will use a combination of digital devices (Emerald touchless sensor system with associated ankle accelerometer, iPhone, Apple Watch, iPad, Fitbit Aria, FitBit Versa, Withings Blood Pressure Monitor Connect, and/or Withings Sleep Mat) during their daily lives.
- Conditions
- Parkinson Disease, Healthy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with PD | Not described | |
| Care Partners of PD participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of digital and remote monitoring technologies
determined by evaluating:
- Ease of deployment and initial set-up, utility of technology and user experience as reported by the usability surveys and interview questionnaires (measured by means of Standard Usability Questionnaire score ranges from 10 to 50, higher score indicating a better usability)
- Total time and percentage of continuous data collection for each stream of data and frequency and distribution of missing data points.
- Mutual consistency of data from multiple, related data streams
- Data utility reports
- Responses from participants with PD and care partners regarding ease of use and comfort of technologies in study
- Adherence of participants to active tasks and use of the devices
Measured: 8 weeks
Secondary outcomes (1)
Correlation with standard measures
Correlation of data from the included digital technologies and their relationship to standard measures (correlations with scores from MDS-UPDRS, PDQ-8 and SE-ADL)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start25 Nov 2020
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthMode Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675853
- Sponsor's protocol ID
- HM041001
- Acronym
- RETRO-PD
- Status last verified
- Jul 2022
- First submitted
- 14 Dec 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid dEvice Testing pROtocol for Parkinson's Disease (RETRO-PD)
- ClinicalTrials.gov ID
- NCT04675853
- Acronym / sponsor ID
- RETRO-PD / HM041001
- Conditions
- Parkinson Disease, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- HealthMode Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 19 Dec 2020 (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.
This is an 8 week observational study to evaluate the feasibility of using remote monitoring technologies in future studies of PD. The study will 2 clinical evaluations (one initial, one final), and an 8-week monitoring period including 4 virtual visits where participants will use a combination of digital devices (Emerald touchless sensor system with associated ankle accelerometer, iPhone, Apple Watch, iPad, Fitbit Aria, FitBit Versa, Withings Blood Pressure Monitor Connect, and/or Withings Sleep Mat) during their daily lives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with PD | – | – |
| Care Partners of PD participants | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll at least 25 dyads consisting of participants with PD and their care partners recruited from multiple clinical practices and the general public. Participants who withdraw from the study before completing virtual visit V04 (day 28) will be replaced. Enrollment will be enriched to ensure that participants are distributed across mild to severe PD.
Key inclusion criteria (17 listed)
- Participants with PD
- At least 30 years of age
- Clinical diagnosis of PD by a neurologist or other movement disorder specialist as reported by the participant, with current motor symptoms
- Able to ambulate independently (assistance of minor walking aids such as a cane is permitted, but depending on a walker for ambulation is not)
- Have a BMI of 33 or below calculated by participant reported height and weight at the time of screening
Key exclusion criteria (11 listed)
- Participants with PD
- Any non-PD forms of Parkinsonism
- Active psychiatric disorders that affect the ability to complete study tasks
- Any other medical condition that is the primary cause of the present movement disorder
- Cognitive dysfunction (score > 7 on the Six-Item Cognitive Impairment Test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The feasibility of digital and remote monitoring technologies
Time frame: 8 weeks
determined by evaluating: 1. Ease of deployment and initial set-up, utility of technology and user experience as reported by the usability surveys and interview questionnaires (measured by means of Standard Usability Questionnaire score ranges from 10 to 50, higher score indicating a better usability) 2. Total time and percentage of continuous data collection for each stream of data and frequency and distribution of missing data points. 3. Mutual consistency of data from multiple, related data streams 4. Data utility reports 5. Responses from participants with PD and care partners regarding ease of use and comfort of technologies in study 6. Adherence of participants to active tasks and use of the devices
1 secondary outcome
Correlation with standard measures
Time frame: 8 weeks
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 22 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Healthy, run by HealthMode Inc. at 1 site in United States.
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 17 inclusion and 11 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 22 Jul 2022. 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 United States. 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. 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?
The feasibility of digital and remote monitoring technologies (time frame: 8 weeks). 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 22 Jul 2022.