Digital Signals in Chronic Pain (DiSCover Project) | NCT03421223

Studies
Digital Signals in Chronic Pain (DiSCover Project)

NCT03421223

Sponsor

Evidation Health

Status

Completed

Last Update Posted

Jul 22, 2020Actual

Enrollment

10,161Actual

Phase

Not provided

Conditions

Chronic Pain

Interventions

No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2018Actual

Primary Completion Date

Dec 26, 2019Actual

Completion Date

Jan 15, 2020Actual

First Submitted Date

Jan 7, 2018

First Submission Date that Met QC Criteria

Jan 29, 2018

First Posted Date

Feb 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2020

Last Update Posted Date

Jul 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case		Individuals diagnosed with chronic pain	Other: No intervention
Control		Individuals without chronic pain	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Case Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported chronic pain severity measured by BPI-SF		1 year
Quality of Life Scale for Pain		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Less than 18 years old
Is not able to read or understand English

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study will recruit virtually and individuals can participate remotely.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jessie L Juusola, PhD	Evidation Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evidation Health		San Mateo	California	94401	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided