Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)
2012年11月29日 更新者：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.
調査の概要
研究の種類
観察的
入学 (実際)
1700
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arkansas
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Hot Springs、Arkansas、アメリカ、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.
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California
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Santa Barbara、California、アメリカ、93108
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Connecticut
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Danbury、Connecticut、アメリカ、06810
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Waterbury、Connecticut、アメリカ、06708
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District of Columbia
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Washington、District of Columbia、アメリカ、20006
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Florida
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Jupiter、Florida、アメリカ、33458
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Tampa、Florida、アメリカ、33609
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Winter Park、Florida、アメリカ、32792
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Georgia
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Blue Ridge、Georgia、アメリカ、30513
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Snellville、Georgia、アメリカ、30078
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Idaho
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Meridian、Idaho、アメリカ、83646
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Nampa、Idaho、アメリカ、83686
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Illinois
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Peoria、Illinois、アメリカ、61614
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Springfield、Illinois、アメリカ、62702
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Indiana
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Evansville、Indiana、アメリカ、47710
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Fishers、Indiana、アメリカ、46038
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Indianapolis、Indiana、アメリカ、46260
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Kentucky
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Louisville、Kentucky、アメリカ、40223
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70808
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Maryland
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Baltimore、Maryland、アメリカ、21222
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Towson、Maryland、アメリカ、21286
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Wheaton、Maryland、アメリカ、20902
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Michigan
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Lansing、Michigan、アメリカ、48910
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Missouri
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West Plains、Missouri、アメリカ、65775
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Nevada
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Reno、Nevada、アメリカ、89502
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New Jersey
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Dover、New Jersey、アメリカ、07801
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East Brunswick、New Jersey、アメリカ、08816
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Medford、New Jersey、アメリカ、08055
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New York
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Schenectady、New York、アメリカ、12308
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North Carolina
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Boone、North Carolina、アメリカ、28607
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Charlotte、North Carolina、アメリカ、28210
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North Dakota
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Minot、North Dakota、アメリカ、58701
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Ohio
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Cincinnati、Ohio、アメリカ、45219
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Cleveland、Ohio、アメリカ、44195
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Findlay、Ohio、アメリカ、45840
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Oklahoma
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Tulsa、Oklahoma、アメリカ、74104
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Pennsylvania
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Duncansville、Pennsylvania、アメリカ、16635
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West Reading、Pennsylvania、アメリカ、19611
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Texas
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Arlington、Texas、アメリカ、76011
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Dallas、Texas、アメリカ、75278
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Flower Mound、Texas、アメリカ、75028
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Garland、Texas、アメリカ、75042
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Grand Prairie、Texas、アメリカ、75050
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Houston、Texas、アメリカ、77034
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Utah
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Salt Lake City、Utah、アメリカ、84102
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Virginia
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Norfolk、Virginia、アメリカ、23502
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Washington
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Kirkland、Washington、アメリカ、98034
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Seattle、Washington、アメリカ、98104
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West Virginia
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Beckley、West Virginia、アメリカ、25801
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Cidra、プエルトリコ、00739
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Hato Rey、プエルトリコ、00920
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Humacao、プエルトリコ、00791
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Levittown、プエルトリコ、00949
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Manati、プエルトリコ、00674
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Mayaguez、プエルトリコ、00680
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Rio Piedras、プエルトリコ、00921
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San German、プエルトリコ、00683
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Santa Isabel、プエルトリコ、00757
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
Multiple care centers
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年6月1日
一次修了 (実際)
2011年4月1日
研究の完了 (実際)
2011年4月1日
試験登録日
最初に提出
2008年7月28日
QC基準を満たした最初の提出物
2008年7月29日
最初の投稿 (見積もり)
2008年7月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年11月30日
QC基準を満たした最後の更新が送信されました
2012年11月29日
最終確認日
2012年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。