Treatment for Fibromyalgia
DrugFM participants starting any new pharmacologic FM agent.
NCT Number: NCT00725101
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
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., Cidra, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FM participants starting any new pharmacologic FM agent.
Time frame: Baseline through 12 months
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 12 months
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 12 months
Time frame: Baseline through 12 months
Time frame: Baseline through 12 months
Partial (day or night) care included day care, day nursing home, and partial hospitalization.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 12 months
Participant productivity was described as the number of days a participant missed work due to FM.
Eli Lilly and Company
Industry
Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)
Acronym: REFLECTIONS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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