Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)
29 ноября 2012 г. обновлено: 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.
Обзор исследования
Тип исследования
Наблюдательный
Регистрация (Действительный)
1700
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Cidra, Пуэрто-Рико, 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, Пуэрто-Рико, 00920
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Humacao, Пуэрто-Рико, 00791
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Levittown, Пуэрто-Рико, 00949
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Manati, Пуэрто-Рико, 00674
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Mayaguez, Пуэрто-Рико, 00680
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Rio Piedras, Пуэрто-Рико, 00921
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San German, Пуэрто-Рико, 00683
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Santa Isabel, Пуэрто-Рико, 00757
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Arkansas
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Hot Springs, Arkansas, Соединенные Штаты, 71913
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California
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Santa Barbara, California, Соединенные Штаты, 93108
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Connecticut
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Danbury, Connecticut, Соединенные Штаты, 06810
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Waterbury, Connecticut, Соединенные Штаты, 06708
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District of Columbia
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Washington, District of Columbia, Соединенные Штаты, 20006
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Florida
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Jupiter, Florida, Соединенные Штаты, 33458
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Tampa, Florida, Соединенные Штаты, 33609
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Winter Park, Florida, Соединенные Штаты, 32792
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Georgia
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Blue Ridge, Georgia, Соединенные Штаты, 30513
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Snellville, Georgia, Соединенные Штаты, 30078
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Idaho
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Meridian, Idaho, Соединенные Штаты, 83646
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Nampa, Idaho, Соединенные Штаты, 83686
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Illinois
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Peoria, Illinois, Соединенные Штаты, 61614
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Springfield, Illinois, Соединенные Штаты, 62702
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Indiana
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Evansville, Indiana, Соединенные Штаты, 47710
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Fishers, Indiana, Соединенные Штаты, 46038
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Indianapolis, Indiana, Соединенные Штаты, 46260
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Kentucky
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Louisville, Kentucky, Соединенные Штаты, 40223
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Louisiana
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Baton Rouge, Louisiana, Соединенные Штаты, 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.
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 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.
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Towson, Maryland, Соединенные Штаты, 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.
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Wheaton, Maryland, Соединенные Штаты, 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, Соединенные Штаты, 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, Соединенные Штаты, 65775
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Nevada
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Reno, Nevada, Соединенные Штаты, 89502
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New Jersey
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Dover, New Jersey, Соединенные Штаты, 07801
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East Brunswick, New Jersey, Соединенные Штаты, 08816
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Medford, New Jersey, Соединенные Штаты, 08055
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New York
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Schenectady, New York, Соединенные Штаты, 12308
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North Carolina
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Boone, North Carolina, Соединенные Штаты, 28607
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Charlotte, North Carolina, Соединенные Штаты, 28210
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North Dakota
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Minot, North Dakota, Соединенные Штаты, 58701
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45219
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Cleveland, Ohio, Соединенные Штаты, 44195
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Findlay, Ohio, Соединенные Штаты, 45840
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Oklahoma
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Tulsa, Oklahoma, Соединенные Штаты, 74104
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Pennsylvania
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Duncansville, Pennsylvania, Соединенные Штаты, 16635
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West Reading, Pennsylvania, Соединенные Штаты, 19611
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Texas
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Arlington, Texas, Соединенные Штаты, 76011
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Dallas, Texas, Соединенные Штаты, 75278
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Flower Mound, Texas, Соединенные Штаты, 75028
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Garland, Texas, Соединенные Штаты, 75042
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Grand Prairie, Texas, Соединенные Штаты, 75050
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Houston, Texas, Соединенные Штаты, 77034
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84102
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23502
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Washington
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Kirkland, Washington, Соединенные Штаты, 98034
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Seattle, Washington, Соединенные Штаты, 98104
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West Virginia
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Beckley, West Virginia, Соединенные Штаты, 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.
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Вероятностная выборка
Исследуемая популяция
Multiple care centers
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: Baseline through 12 months
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Baseline through 12 months
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|
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Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 июня 2008 г.
Первичное завершение (Действительный)
1 апреля 2011 г.
Завершение исследования (Действительный)
1 апреля 2011 г.
Даты регистрации исследования
Первый отправленный
28 июля 2008 г.
Впервые представлено, что соответствует критериям контроля качества
29 июля 2008 г.
Первый опубликованный (Оценивать)
30 июля 2008 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
30 ноября 2012 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 ноября 2012 г.
Последняя проверка
1 апреля 2012 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 11540
- F1J-MC-B020 (Другой идентификатор: Eli Lilly and Company)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .