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Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)

29 listopada 2012 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Fibromialgia

Interwencja / Leczenie

Lek: Treatment for Fibromyalgia

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

1700

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Portoryko
- - Cidra, Portoryko, 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.
  - Hato Rey, Portoryko, 00920
    - 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.
  - Humacao, Portoryko, 00791
    - 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.
  - Levittown, Portoryko, 00949
    - 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.
  - Manati, Portoryko, 00674
    - 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.
  - Mayaguez, Portoryko, 00680
    - 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.
  - Rio Piedras, Portoryko, 00921
    - 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.
  - San German, Portoryko, 00683
    - 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.
  - Santa Isabel, Portoryko, 00757
    - 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.
Stany Zjednoczone
- Arkansas
  - Hot Springs, Arkansas, Stany Zjednoczone, 71913
    - 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.
- California
  - Santa Barbara, California, Stany Zjednoczone, 93108
    - 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.
- Connecticut
  - Danbury, Connecticut, Stany Zjednoczone, 06810
    - 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.
  - Waterbury, Connecticut, Stany Zjednoczone, 06708
    - 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.
- District of Columbia
  - Washington, District of Columbia, Stany Zjednoczone, 20006
    - 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.
- Florida
  - Jupiter, Florida, Stany Zjednoczone, 33458
    - 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.
  - Tampa, Florida, Stany Zjednoczone, 33609
    - 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.
  - Winter Park, Florida, Stany Zjednoczone, 32792
    - 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.
- Georgia
  - Blue Ridge, Georgia, Stany Zjednoczone, 30513
    - 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.
  - Snellville, Georgia, Stany Zjednoczone, 30078
    - 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.
- Idaho
  - Meridian, Idaho, Stany Zjednoczone, 83646
    - 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.
  - Nampa, Idaho, Stany Zjednoczone, 83686
    - 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.
- Illinois
  - Peoria, Illinois, Stany Zjednoczone, 61614
    - 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.
  - Springfield, Illinois, Stany Zjednoczone, 62702
    - 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.
- Indiana
  - Evansville, Indiana, Stany Zjednoczone, 47710
    - 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.
  - Fishers, Indiana, Stany Zjednoczone, 46038
    - 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.
  - Indianapolis, Indiana, Stany Zjednoczone, 46260
    - 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.
- Kentucky
  - Louisville, Kentucky, Stany Zjednoczone, 40223
    - 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.
- Louisiana
  - Baton Rouge, Louisiana, Stany Zjednoczone, 70808
    - 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.
- Maryland
  - Baltimore, Maryland, Stany Zjednoczone, 21222
    - 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.
  - Towson, Maryland, Stany Zjednoczone, 21286
    - 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.
  - Wheaton, Maryland, Stany Zjednoczone, 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.
- Michigan
  - Lansing, Michigan, Stany Zjednoczone, 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.
- Missouri
  - West Plains, Missouri, Stany Zjednoczone, 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.
- Nevada
  - Reno, Nevada, Stany Zjednoczone, 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.
- New Jersey
  - Dover, New Jersey, Stany Zjednoczone, 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.
  - East Brunswick, New Jersey, Stany Zjednoczone, 08816
    - 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.
  - Medford, New Jersey, Stany Zjednoczone, 08055
    - 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.
- New York
  - Schenectady, New York, Stany Zjednoczone, 12308
    - 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.
- North Carolina
  - Boone, North Carolina, Stany Zjednoczone, 28607
    - 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.
  - Charlotte, North Carolina, Stany Zjednoczone, 28210
    - 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.
- North Dakota
  - Minot, North Dakota, Stany Zjednoczone, 58701
    - 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.
- Ohio
  - Cincinnati, Ohio, Stany Zjednoczone, 45219
    - 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.
  - Cleveland, Ohio, Stany Zjednoczone, 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.
  - Findlay, Ohio, Stany Zjednoczone, 45840
    - 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.
- Oklahoma
  - Tulsa, Oklahoma, Stany Zjednoczone, 74104
    - 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.
- Pennsylvania
  - Duncansville, Pennsylvania, Stany Zjednoczone, 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.
  - West Reading, Pennsylvania, Stany Zjednoczone, 19611
    - 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.
- Texas
  - Arlington, Texas, Stany Zjednoczone, 76011
    - 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.
  - Dallas, Texas, Stany Zjednoczone, 75278
    - 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.
  - Flower Mound, Texas, Stany Zjednoczone, 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.
  - Garland, Texas, Stany Zjednoczone, 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.
  - Grand Prairie, Texas, Stany Zjednoczone, 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.
  - Houston, Texas, Stany Zjednoczone, 77034
    - 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.
- Utah
  - Salt Lake City, Utah, Stany Zjednoczone, 84102
    - 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.
- Virginia
  - Norfolk, Virginia, Stany Zjednoczone, 23502
    - 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.
- Washington
  - Kirkland, Washington, Stany Zjednoczone, 98034
    - 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.
  - Seattle, Washington, Stany Zjednoczone, 98104
    - 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.
- West Virginia
  - Beckley, West Virginia, Stany Zjednoczone, 25801
    - 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.

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

Multiple care centers

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta	Interwencja / Leczenie
Fibromyalgia (FM) Participants FM participants starting any new pharmacologic FM agent.	Lek: Treatment for Fibromyalgia FM participants starting any new pharmacologic FM agent.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months Ramy czasowe: Baseline through 12 months		Baseline through 12 months
Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication Ramy czasowe: 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.	Baseline through 12 months
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 Ramy czasowe: 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.	Baseline through 12 months

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study Ramy czasowe: 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.	Baseline through 12 months
Percentage of Participants Who Discontinued Opioids Ramy czasowe: Baseline through 12 months		Baseline through 12 months
Hazard Ratios for Factors Associated With Discontinued Opioid Use Ramy czasowe: 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.	Baseline through 12 months
Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months Ramy czasowe: 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.	Baseline, 12 months
Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months Ramy czasowe: 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.	Baseline, 12 months
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months Ramy czasowe: 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.	Baseline, 12 months
Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months Ramy czasowe: Baseline, 12 months	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.	Baseline, 12 months
Number of Outpatient Visits Due to Fibromyalgia (FM) Ramy czasowe: Baseline through 12 months		Baseline through 12 months
Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM) Ramy czasowe: Baseline through 12 months		Baseline through 12 months
Number of Days of Partial Care for Fibromyalgia (FM) Participants Ramy czasowe: Baseline through 12 months	Partial (day or night) care included day care, day nursing home, and partial hospitalization.	Baseline through 12 months
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver) Ramy czasowe: 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.	Baseline through 12 months
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver) Ramy czasowe: 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
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income) Ramy czasowe: 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
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work) Ramy czasowe: Baseline through 12 months	Participant productivity was described as the number of days a participant missed work due to FM.	Baseline through 12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Eli Lilly and Company

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 czerwca 2008

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2011

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2011

Daty rejestracji na studia

Pierwszy przesłany

28 lipca 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 lipca 2008

Pierwszy wysłany (Oszacować)

30 lipca 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

30 listopada 2012

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 listopada 2012

Ostatnia weryfikacja

1 kwietnia 2012

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

11540
F1J-MC-B020 (Inny identyfikator: Eli Lilly and Company)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Fibromialgia

Santa Casa da Misericordia do Rio de Janeiro Hospital

Nieznany

Próba akupunktury w leczeniu fibromialgii

Fibromialgia | Zespół bólu mięśniowo-powięziowego, rozlany | Rozlany zespół bólu mięśniowo-powięziowego | Zespół fibromialgii i zapalenia mięśni włóknistych | Zespół Fibromyositis-Fibromyalgia

Brazylia

Badania kliniczne na Treatment for Fibromyalgia

Forendo Pharma Ltd
Richmond Pharmacology Limited

Zakończony

Badanie względnej biodostępności FOR-6219 w kapsułkach i tabletkach

Względna biodostępność

Zjednoczone Królestwo
Mary Lacy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Aktywny, nie rekrutujący

Korzystanie z ułatwień w praktyce i operacjonalizacja technologii informacyjnej skierowań w celu zwiększenia wykorzystania DSMES

Cukrzyca

Stany Zjednoczone
Memorial Sloan Kettering Cancer Center

Zakończony

Poprawa opieki u schyłku życia w przypadku raka głowy i szyi

Rodziny lub najbliżsi krewni pacjentów leczonych w MSKCC z powodu nieskórnego raka płaskonabłonkowego | Górny przewód pokarmowy

Stany Zjednoczone
Forendo Pharma Ltd
Richmond Pharmacology Limited

Zakończony

Badanie mające na celu zbadanie bezpieczeństwa, tolerancji, wpływu pokarmu, farmakokinetyki i farmakodynamiki FOR-6219

Endometrioza

Zjednoczone Królestwo
Université de Sherbrooke

Rejestracja na zaproszenie

Obserwacja dzieci urodzonych w wyniku interwencji dotyczącej stylu życia przed poczęciem u kobiet cierpiących na otyłość i niepłodność

Otyłość, dzieciństwo | Interwencja w styl życia | Opieka przedkoncepcyjna

Kanada
Duke University

Zakończony

DeStress for Health: Współpraca z hrabstwami Granville i Vance w celu zmniejszenia stresu i ryzyka raka

Redukcja stresu

Stany Zjednoczone
University College Dublin

Aktywny, nie rekrutujący

Skuteczność szkolnego programu dobrostanu w zakresie internalizacji problemów u dzieci w irlandzkich szkołach podstawowych

Lęk | Niski nastrój

Irlandia
University of Washington, the Collaborative Health...
Cystic Fibrosis Foundation

Zakończony

Sól fizjologiczna hipertoniczna u przedszkolaków + tomografia komputerowa (SHIP-CT)

Mukowiscydoza

Hiszpania, Stany Zjednoczone, Australia, Włochy, Francja, Kanada, Belgia, Dania, Holandia
University of Washington
National Institute on Drug Abuse (NIDA)

Rekrutacyjny

Wakaya: Rising Up for Choctaw Youth Health (Wakaya)

Otyłość, nastolatek | Siedzący tryb życia | Narkomania | Zdrowe odżywianie

Stany Zjednoczone
Donna R Zwas

Rekrutacyjny

Partners For Life: Program promocji zdrowia offline dla ultraortodoksyjnych Żydówek podczas pandemii COVID-19

Zachowanie zdrowotne

Izrael

Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)

Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Typ studiów

Zapisy (Rzeczywisty)

Kontakty i lokalizacje

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Metoda próbkowania

Badana populacja

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów

Zakończenie podstawowe (Rzeczywisty)

Ukończenie studiów (Rzeczywisty)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Oszacować)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Badania kliniczne na Fibromialgia

Badania kliniczne na Treatment for Fibromyalgia

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Kyrgyzstan

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje