Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)
29 november 2012 bijgewerkt door: Eli Lilly and Company
Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Werkelijk)
1700
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Cidra, Puerto Rico, 00739
- 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.
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Hato Rey, Puerto Rico, 00920
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Humacao, Puerto Rico, 00791
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Levittown, Puerto Rico, 00949
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Manati, Puerto Rico, 00674
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Mayaguez, Puerto Rico, 00680
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Rio Piedras, Puerto Rico, 00921
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San German, Puerto Rico, 00683
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Santa Isabel, Puerto Rico, 00757
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Arkansas
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Hot Springs, Arkansas, Verenigde Staten, 71913
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California
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Santa Barbara, California, Verenigde Staten, 93108
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Connecticut
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Danbury, Connecticut, Verenigde Staten, 06810
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Waterbury, Connecticut, Verenigde Staten, 06708
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20006
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Florida
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Jupiter, Florida, Verenigde Staten, 33458
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Tampa, Florida, Verenigde Staten, 33609
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Winter Park, Florida, Verenigde Staten, 32792
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Georgia
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Blue Ridge, Georgia, Verenigde Staten, 30513
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Snellville, Georgia, Verenigde Staten, 30078
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Idaho
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Meridian, Idaho, Verenigde Staten, 83646
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Nampa, Idaho, Verenigde Staten, 83686
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Illinois
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Peoria, Illinois, Verenigde Staten, 61614
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Springfield, Illinois, Verenigde Staten, 62702
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Indiana
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Evansville, Indiana, Verenigde Staten, 47710
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Fishers, Indiana, Verenigde Staten, 46038
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Indianapolis, Indiana, Verenigde Staten, 46260
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40223
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70808
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21222
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Towson, Maryland, Verenigde Staten, 21286
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Wheaton, Maryland, Verenigde Staten, 20902
- 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.
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Michigan
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Lansing, Michigan, Verenigde Staten, 48910
- 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.
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Missouri
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West Plains, Missouri, Verenigde Staten, 65775
- 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.
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Nevada
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Reno, Nevada, Verenigde Staten, 89502
- 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.
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New Jersey
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Dover, New Jersey, Verenigde Staten, 07801
- 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.
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East Brunswick, New Jersey, Verenigde Staten, 08816
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Medford, New Jersey, Verenigde Staten, 08055
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New York
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Schenectady, New York, Verenigde Staten, 12308
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North Carolina
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Boone, North Carolina, Verenigde Staten, 28607
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Charlotte, North Carolina, Verenigde Staten, 28210
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North Dakota
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Minot, North Dakota, Verenigde Staten, 58701
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45219
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Cleveland, Ohio, Verenigde Staten, 44195
- 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.
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Findlay, Ohio, Verenigde Staten, 45840
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74104
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Pennsylvania
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Duncansville, Pennsylvania, Verenigde Staten, 16635
- 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.
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West Reading, Pennsylvania, Verenigde Staten, 19611
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Texas
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Arlington, Texas, Verenigde Staten, 76011
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Dallas, Texas, Verenigde Staten, 75278
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Flower Mound, Texas, Verenigde Staten, 75028
- 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.
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Garland, Texas, Verenigde Staten, 75042
- 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.
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Grand Prairie, Texas, Verenigde Staten, 75050
- 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.
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Houston, Texas, Verenigde Staten, 77034
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84102
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23502
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Washington
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Kirkland, Washington, Verenigde Staten, 98034
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Seattle, Washington, Verenigde Staten, 98104
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West Virginia
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Beckley, West Virginia, Verenigde Staten, 25801
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Multiple care centers
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Fibromyalgia (FM) Participants
FM participants starting any new pharmacologic FM agent.
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FM participants starting any new pharmacologic FM agent.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Tijdsspanne: Baseline through 12 months
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Baseline through 12 months
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Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication
Tijdsspanne: Baseline through 12 months
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Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.
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Baseline through 12 months
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Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use
Tijdsspanne: Baseline through 12 months
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Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity [not at all severe, severe for several days, severe for more than half the days, severe nearly every day]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety).
Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.
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Baseline through 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Tijdsspanne: Baseline through 12 months
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Participants were allowed to select multiple reasons for discontinuing treatment.
During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once.
A reason for discontinuation was given each time a participant stopped taking a medication.
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Baseline through 12 months
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Percentage of Participants Who Discontinued Opioids
Tijdsspanne: Baseline through 12 months
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Baseline through 12 months
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Hazard Ratios for Factors Associated With Discontinued Opioid Use
Tijdsspanne: Baseline through 12 months
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Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.
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Baseline through 12 months
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Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months
Tijdsspanne: Baseline, 12 months
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Average BPI-I measures self-reported degree of pain interference on function.
Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Average interference = average of non-missing scores of individual interference items.
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Baseline, 12 months
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Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months
Tijdsspanne: Baseline, 12 months
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BPI-S measures self-reported severity of pain.
Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.
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Baseline, 12 months
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Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months
Tijdsspanne: Baseline, 12 months
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FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week.
FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms.
Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression.
Total scores range from 0-80; Higher score=greater negative impact.
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Baseline, 12 months
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Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months
Tijdsspanne: Baseline, 12 months
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The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life.
Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.
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Baseline, 12 months
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Number of Outpatient Visits Due to Fibromyalgia (FM)
Tijdsspanne: Baseline through 12 months
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Baseline through 12 months
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Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)
Tijdsspanne: Baseline through 12 months
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Baseline through 12 months
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Number of Days of Partial Care for Fibromyalgia (FM) Participants
Tijdsspanne: Baseline through 12 months
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Partial (day or night) care included day care, day nursing home, and partial hospitalization.
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Baseline through 12 months
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Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)
Tijdsspanne: Baseline through 12 months
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Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.
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Baseline through 12 months
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Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)
Tijdsspanne: Baseline through 12 months
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Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.
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Baseline through 12 months
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Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)
Tijdsspanne: Baseline through 12 months
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Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.
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Baseline through 12 months
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Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)
Tijdsspanne: Baseline through 12 months
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Participant productivity was described as the number of days a participant missed work due to FM.
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Baseline through 12 months
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Medewerkers en onderzoekers
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2008
Primaire voltooiing (Werkelijk)
1 april 2011
Studie voltooiing (Werkelijk)
1 april 2011
Studieregistratiedata
Eerst ingediend
28 juli 2008
Eerst ingediend dat voldeed aan de QC-criteria
29 juli 2008
Eerst geplaatst (Schatting)
30 juli 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
30 november 2012
Laatste update ingediend die voldeed aan QC-criteria
29 november 2012
Laatst geverifieerd
1 april 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11540
- F1J-MC-B020 (Andere identificatie: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .