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Fibromyalgia Health Outcome Study on Cost of Treatments

NCT ID: NCT00725101

Last Updated: 2012-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-04-30

Brief Summary

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The Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (REFLECTIONS) Study is a 12-month, prospective observational study that will be utilized in approximately 58 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of adult participants diagnosed by their physician with fibromyalgia (FM) and who are starting any "new pharmacologic agent" for FM.

The primary benefit of this study is enhanced understanding of the disease state of FM and the role that pharmacologic treatment plays, which may help to optimize management of FM. This study will address current gaps in a rapidly growing body of literature on FM.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fibromyalgia (FM) Participants

FM participants starting any new pharmacologic FM agent.

Treatment for Fibromyalgia

Intervention Type DRUG

FM participants starting any new pharmacologic FM agent.

Interventions

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Treatment for Fibromyalgia

FM participants starting any new pharmacologic FM agent.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meet criteria for fibromyalgia (FM) in the opinion of the investigator
* Must be prescribed a 'new' treatment for FM
* Male and female participants at least 18 years of age
* Willing to complete the Informed Consent Document (ICD) and any other required forms to be eligible for study participation
* Currently under the care of the participating physician
* Cognitively able to understand and complete participant self-rated scales in English or Spanish via computer-assisted telephone interview (CATI)
* Available for 12 months to participate in the study

Exclusion Criteria

* Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
* Are Lilly employees
* Are Terminally ill
* Currently participating in other research studies or if beginning a research study while participating in this study
* Unable to respond via telephone for CATI
* Incompetent for interview as deemed by the participating physician
* Unwilling to provide written ICD or other required forms to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hot Springs, Arkansas, United States

Site Status

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Santa Barbara, California, United States

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Danbury, Connecticut, United States

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Waterbury, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Jupiter, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Blue Ridge, Georgia, United States

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Snellville, Georgia, United States

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Meridian, Idaho, United States

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Nampa, Idaho, United States

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Peoria, Illinois, United States

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Springfield, Illinois, United States

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Evansville, Indiana, United States

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Fishers, Indiana, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Towson, Maryland, United States

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Wheaton, Maryland, United States

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Lansing, Michigan, United States

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West Plains, Missouri, United States

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Reno, Nevada, United States

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Dover, New Jersey, United States

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East Brunswick, New Jersey, United States

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Medford, New Jersey, United States

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Schenectady, New York, United States

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Boone, North Carolina, United States

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Charlotte, North Carolina, United States

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Minot, North Dakota, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Findlay, Ohio, United States

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Tulsa, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Flower Mound, Texas, United States

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Garland, Texas, United States

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Grand Prairie, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Beckley, West Virginia, United States

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Cidra, , Puerto Rico

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Hato Rey, , Puerto Rico

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Humacao, , Puerto Rico

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Levittown, , Puerto Rico

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Manatí, , Puerto Rico

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Mayagüez, , Puerto Rico

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Rio Piedras, , Puerto Rico

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San Germán, , Puerto Rico

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Santa Isabel, , Puerto Rico

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Countries

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United States Puerto Rico

Other Identifiers

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F1J-MC-B020

Identifier Type: OTHER

Identifier Source: secondary_id

11540

Identifier Type: -

Identifier Source: org_study_id