Chronic PainNCT03421223
Digital Signals in Chronic Pain (DiSCover Project)
An observational study of Chronic Pain, run by Evidation Health at 1 site in United States.
Trial summary
The DiSCover Project is a 1-year longitudinal case-control observational study. In this study, the investigators plan to collect different types of data including self-reported health outcomes and quality of life data, behavioral data from activity trackers and health and fitness apps, data from lab tests, genetic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- How many people
- 10,161 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 15 Jan 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will recruit virtually and individuals can participate remotely.
Who may be able to join
- Age 18 years or older
- Resides in the United States
- Case Inclusion Criteria: Self-reported diagnosis of chronic pain and experiences moderate chronic pain as assessed by scoring at least 4 on the Numeric Pain Rating Scale
- Control Inclusion Criteria: Self-reported not having chronic pain
Who cannot join
- Less than 18 years old
- Is not able to read or understand English
Trial locations and contacts
1 site in 1 country.
About this study
The DiSCover Project is a 1-year longitudinal case-control observational study. In this study, the investigators plan to collect different types of data including self-reported health outcomes and quality of life data, behavioral data from activity trackers and health and fitness apps, data from lab tests, genetic data, and environmental data. One of the goals of this study is to develop digital biomarkers for chronic pain severity, flare ups and quality of life.
- Conditions
- Chronic Pain
- Being tested
- No intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Case | Individuals diagnosed with chronic pain Receives: Other: No intervention | |
| Control | Individuals without chronic pain Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported chronic pain severity measured by BPI-SF
Measured: 1 year
Quality of Life Scale for Pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start8 Jan 2018
- Primary completion26 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evidation Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessie L Juusola, PhD, Principal investigator, Evidation Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421223
- Sponsor's protocol ID
- EH-007
- Status last verified
- Jul 2020
- First submitted
- 7 Jan 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Signals in Chronic Pain (DiSCover Project)
- ClinicalTrials.gov ID
- NCT03421223
- Acronym / sponsor ID
- EH-007
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,161 participants (actual)
- Lead sponsor
- Evidation HealthIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 5 Feb 2018 (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.
The DiSCover Project is a 1-year longitudinal case-control observational study. In this study, the investigators plan to collect different types of data including self-reported health outcomes and quality of life data, behavioral data from activity trackers and health and fitness apps, data from lab tests, genetic data, and environmental data. One of the goals of this study is to develop digital biomarkers for chronic pain severity, flare ups and quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: No interventionIndividuals diagnosed with chronic pain |
| Control | – | Other: No interventionIndividuals without chronic pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit virtually and individuals can participate remotely.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Resides in the United States
- Case Inclusion Criteria: Self-reported diagnosis of chronic pain and experiences moderate chronic pain as assessed by scoring at least 4 on the Numeric Pain Rating Scale
- Control Inclusion Criteria: Self-reported not having chronic pain
Key exclusion criteria (2 listed)
- Less than 18 years old
- Is not able to read or understand English
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 |
|---|---|---|
| No interventionNo intervention | Other | Case, Control |
Primary outcome
Self-reported chronic pain severity measured by BPI-SF
Time frame: 1 year
Quality of Life Scale for Pain
Time frame: 1 year
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 2020.
- Individual participant dataSharing planned: No
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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.
Jessie L Juusola, PhD principal investigator
Evidation Health
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 Chronic Pain, run by Evidation Health 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 4 inclusion and 2 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 2020. 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?
Self-reported chronic pain severity measured by BPI-SF (time frame: 1 year). The study lists 2 primary outcomes in all. 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 2020.