Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)
2012년 11월 29일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (실제)
1700
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arkansas
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Hot Springs, Arkansas, 미국, 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, 미국, 93108
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Connecticut
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Danbury, Connecticut, 미국, 06810
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Waterbury, Connecticut, 미국, 06708
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District of Columbia
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Washington, District of Columbia, 미국, 20006
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Florida
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Jupiter, Florida, 미국, 33458
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Tampa, Florida, 미국, 33609
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Winter Park, Florida, 미국, 32792
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Georgia
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Blue Ridge, Georgia, 미국, 30513
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Snellville, Georgia, 미국, 30078
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Idaho
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Meridian, Idaho, 미국, 83646
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Nampa, Idaho, 미국, 83686
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Illinois
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Peoria, Illinois, 미국, 61614
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Springfield, Illinois, 미국, 62702
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Indiana
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Evansville, Indiana, 미국, 47710
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Fishers, Indiana, 미국, 46038
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Indianapolis, Indiana, 미국, 46260
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Kentucky
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Louisville, Kentucky, 미국, 40223
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Louisiana
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Baton Rouge, Louisiana, 미국, 70808
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Maryland
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Baltimore, Maryland, 미국, 21222
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Towson, Maryland, 미국, 21286
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Wheaton, Maryland, 미국, 20902
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Michigan
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Lansing, Michigan, 미국, 48910
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Missouri
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West Plains, Missouri, 미국, 65775
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Nevada
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Reno, Nevada, 미국, 89502
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New Jersey
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Dover, New Jersey, 미국, 07801
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East Brunswick, New Jersey, 미국, 08816
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Medford, New Jersey, 미국, 08055
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New York
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Schenectady, New York, 미국, 12308
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North Carolina
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Boone, North Carolina, 미국, 28607
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Charlotte, North Carolina, 미국, 28210
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North Dakota
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Minot, North Dakota, 미국, 58701
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Ohio
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Cincinnati, Ohio, 미국, 45219
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Cleveland, Ohio, 미국, 44195
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Findlay, Ohio, 미국, 45840
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Oklahoma
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Tulsa, Oklahoma, 미국, 74104
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Pennsylvania
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Duncansville, Pennsylvania, 미국, 16635
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West Reading, Pennsylvania, 미국, 19611
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Texas
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Arlington, Texas, 미국, 76011
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Dallas, Texas, 미국, 75278
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Flower Mound, Texas, 미국, 75028
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Garland, Texas, 미국, 75042
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Grand Prairie, Texas, 미국, 75050
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Houston, Texas, 미국, 77034
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Utah
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Salt Lake City, Utah, 미국, 84102
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Virginia
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Norfolk, Virginia, 미국, 23502
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Washington
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Kirkland, Washington, 미국, 98034
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Seattle, Washington, 미국, 98104
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West Virginia
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Beckley, West Virginia, 미국, 25801
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Cidra, 푸에르토 리코, 00739
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Hato Rey, 푸에르토 리코, 00920
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Humacao, 푸에르토 리코, 00791
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Levittown, 푸에르토 리코, 00949
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Manati, 푸에르토 리코, 00674
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Mayaguez, 푸에르토 리코, 00680
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Rio Piedras, 푸에르토 리코, 00921
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San German, 푸에르토 리코, 00683
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Santa Isabel, 푸에르토 리코, 00757
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Multiple care centers
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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.
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Baseline through 12 months
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Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)
기간: Baseline through 12 months
|
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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 6월 1일
기본 완료 (실제)
2011년 4월 1일
연구 완료 (실제)
2011년 4월 1일
연구 등록 날짜
최초 제출
2008년 7월 28일
QC 기준을 충족하는 최초 제출
2008년 7월 29일
처음 게시됨 (추정)
2008년 7월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 11월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 11월 29일
마지막으로 확인됨
2012년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .