Virtual Specialty Clinic for Fibromyalgia Care | NCT05978297

Studies
Virtual Specialty Clinic for Fibromyalgia Care

NCT05978297

Sponsor

Swing Therapeutics, Inc.

Status

Active, not recruiting

Last Update Posted

Aug 15, 2023Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Fibromyalgia

Interventions

Not provided

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 2027Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Jul 28, 2023

First Submission Date that Met QC Criteria

Jul 28, 2023

First Posted Date

Aug 7, 2023Actual

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

Aug 11, 2023

Last Update Posted Date

Aug 15, 2023Actual

Name	Class
Swing Care Provider Group	UNKNOWN

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

This is an ongoing, prospective, and retrospective cohort study of fibromyalgia patients who receive clinical care at Swing Care (a fibromyalgia virtual specialty clinic).

Deidentified data on demographics, clinical outcomes, patients' treatment engagement and preference, as well as patients' satisfaction are obtained and analyzed via retrospective and prospective chart review.

A waiver of informed consent has been approved by the reviewing Institutional Review Board.

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

2,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demographic and clinical data obtained via chart review [ Time Frame: 5 years ]	This is a clinic based registry of fibromyalgia patient outcomes from patients at the Swing Care clinic to be collected over time.	01 Oct 2022 - 01 Oct 2027

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of Swing Care between 1 Oct, 2022 and 1 Oct, 2027, who received clinical evaluations and/or treatments according to Swing Care's standard clinical care protocol.

Exclusion Criteria: None

Accepts Healthy Volunteers

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

All adult fibromyalgia patients who receive clinical care at Swing Care.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea L Chadwick	Swing Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swing Care		Covina	California	91723	United States

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided