Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)
torstai 29. marraskuuta 2012 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Havainnollistava
Ilmoittautuminen (Todellinen)
1700
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Cidra, Puerto Rico, 00739
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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, Yhdysvallat, 71913
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California
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Santa Barbara, California, Yhdysvallat, 93108
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Connecticut
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Danbury, Connecticut, Yhdysvallat, 06810
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Waterbury, Connecticut, Yhdysvallat, 06708
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District of Columbia
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Washington, District of Columbia, Yhdysvallat, 20006
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Florida
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Jupiter, Florida, Yhdysvallat, 33458
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Tampa, Florida, Yhdysvallat, 33609
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Winter Park, Florida, Yhdysvallat, 32792
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Georgia
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Blue Ridge, Georgia, Yhdysvallat, 30513
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Snellville, Georgia, Yhdysvallat, 30078
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Idaho
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Meridian, Idaho, Yhdysvallat, 83646
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Nampa, Idaho, Yhdysvallat, 83686
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Illinois
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Peoria, Illinois, Yhdysvallat, 61614
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Springfield, Illinois, Yhdysvallat, 62702
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Indiana
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Evansville, Indiana, Yhdysvallat, 47710
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Fishers, Indiana, Yhdysvallat, 46038
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Indianapolis, Indiana, Yhdysvallat, 46260
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40223
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Louisiana
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Baton Rouge, Louisiana, Yhdysvallat, 70808
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Maryland
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Baltimore, Maryland, Yhdysvallat, 21222
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Towson, Maryland, Yhdysvallat, 21286
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Wheaton, Maryland, Yhdysvallat, 20902
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Michigan
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Lansing, Michigan, Yhdysvallat, 48910
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Missouri
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West Plains, Missouri, Yhdysvallat, 65775
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Nevada
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Reno, Nevada, Yhdysvallat, 89502
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New Jersey
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Dover, New Jersey, Yhdysvallat, 07801
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East Brunswick, New Jersey, Yhdysvallat, 08816
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Medford, New Jersey, Yhdysvallat, 08055
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New York
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Schenectady, New York, Yhdysvallat, 12308
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North Carolina
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Boone, North Carolina, Yhdysvallat, 28607
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Charlotte, North Carolina, Yhdysvallat, 28210
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North Dakota
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Minot, North Dakota, Yhdysvallat, 58701
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45219
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Cleveland, Ohio, Yhdysvallat, 44195
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Findlay, Ohio, Yhdysvallat, 45840
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Oklahoma
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Tulsa, Oklahoma, Yhdysvallat, 74104
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Pennsylvania
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Duncansville, Pennsylvania, Yhdysvallat, 16635
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West Reading, Pennsylvania, Yhdysvallat, 19611
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Texas
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Arlington, Texas, Yhdysvallat, 76011
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Dallas, Texas, Yhdysvallat, 75278
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Flower Mound, Texas, Yhdysvallat, 75028
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Garland, Texas, Yhdysvallat, 75042
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Grand Prairie, Texas, Yhdysvallat, 75050
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Houston, Texas, Yhdysvallat, 77034
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Utah
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Salt Lake City, Utah, Yhdysvallat, 84102
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Virginia
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Norfolk, Virginia, Yhdysvallat, 23502
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Washington
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Kirkland, Washington, Yhdysvallat, 98034
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Seattle, Washington, Yhdysvallat, 98104
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West Virginia
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Beckley, West Virginia, Yhdysvallat, 25801
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Näytteenottomenetelmä
Todennäköisyysnäyte
Tutkimusväestö
Multiple care centers
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Aikaikkuna: 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
Aikaikkuna: Baseline through 12 months
|
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
Aikaikkuna: Baseline through 12 months
|
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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Aikaikkuna: Baseline through 12 months
|
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
Aikaikkuna: 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
Aikaikkuna: Baseline through 12 months
|
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
Aikaikkuna: Baseline, 12 months
|
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
Aikaikkuna: Baseline, 12 months
|
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
Aikaikkuna: Baseline, 12 months
|
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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: Baseline through 12 months
|
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)
Aikaikkuna: Baseline through 12 months
|
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.
|
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)
Aikaikkuna: Baseline through 12 months
|
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.
|
Baseline through 12 months
|
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Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)
Aikaikkuna: Baseline through 12 months
|
Participant productivity was described as the number of days a participant missed work due to FM.
|
Baseline through 12 months
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. kesäkuuta 2008
Ensisijainen valmistuminen (Todellinen)
Perjantai 1. huhtikuuta 2011
Opintojen valmistuminen (Todellinen)
Perjantai 1. huhtikuuta 2011
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 28. heinäkuuta 2008
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 29. heinäkuuta 2008
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 30. heinäkuuta 2008
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 30. marraskuuta 2012
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 29. marraskuuta 2012
Viimeksi vahvistettu
Sunnuntai 1. huhtikuuta 2012
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 11540
- F1J-MC-B020 (Muu tunniste: Eli Lilly and Company)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .