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Trial · NCT04445792

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Individuals Identified as Potential Participants Through EHR (Electronic Health Record)Up to 3 yearsPotential participants identified for the Acute Pain, Chronic Pain, and Depression Trials through EHR.
PrimaryNumber of Individuals Who Were Screened to the Acute Pain, Chronic Pain, and Depression TrialsUp to 3 yearsIndividuals who were screened to be in the Acute Pain, Chronic Pain and Depression Trials.
PrimaryNumber of Participants Who Were Randomized to the Acute Pain, Chronic Pain, and Depression TrialsUp to 3 yearsIndividuals who were randomized to be in the Acute Pain, Chronic Pain and Depression Trials.
SecondaryPain Interference as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)6 months
The 6-item PROMIS 43 subscale for pain interference assesses the extent to which participants experience interference with daily activities over the past 7 days using a 5-point Likert scale. The pain interference subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 41.1 to 76.3. Higher scores reflect greater pain interference.
SecondaryPhysical Function as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)6 months
The 6-item PROMIS 43 subscale for physical functioning assesses a participants physical functioning over the past 7 days using a 5-point Likert scale. The physical functioning sub scale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables. T-scores range from 21.0 to 59.0. Higher T-scores reflect higher levels of physical functioning.
SecondarySleep Disturbance as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)6 months
The 6-item PROMIS 43 subscale for sleep disturbance assesses the extent to which participants experience sleep disturbance related symptoms sleep over the past 7 days using a 5-point Likert scale. The sleep disturbance subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMNIS conversion tables, ranging from 31.7 to 76.1. Higher scores reflect higher levels of sleep disturbance.
SecondaryAbility to Participant in Social Roles and Activities as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)6 months
The 6-item PROMIS 43 subscale for ability to participate in social roles and activities assesses the extent to which participants are able to participant in different social roles and activities over the past 7 days using a 5-point Likert scale. The ability to participant in social roles and activities subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 26.7 to 65.0 with higher values corresponding to a higher ability to participant in social roles and activities.
SecondaryFatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)6 months
The 6-item PROMIS 43 subscale for fatigue assesses the extent to which participants experience fatigue-related symptoms over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater fatigue symptoms.
SecondaryAnxiety as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)6 months
The 6-item PROMIS subscale for anxiety assesses the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale. The anxiety subscale provides a raw score, ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 33.4 to 76.8. Higher T-scores reflect greater anxiety.
SecondaryDepression as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)6 months
The 6-item PROMIS 43 subscale for depression assesses the extent to which participants experience depressive symptoms over the past 7 days using a 5-point Likert scale. The depression subscale provides a raw sore ranging from 6 to 30. Raw scores are converted to T-scores using the PROMIS conversion tables, T-scores range from 38.4 to 80.3. Higher T-scores reflect greater depression.
SecondaryOverall Wellbeing as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)6 months
Overall wellbeing is the sum of the PROMIS 43 subdomain T-scores, with physical function and ability to participate in social roles scores reversed such that higher values within each subscale correspond with poorer health. Overall wellbeing ranges from 259.7 to 541.2, higher scores correspond to worse wellbeing.
SecondaryNumber of Participants With Pharmacogenetic Drug-Gene Concordance10 days for Acute Pain; 3 months for Chronic Pain and DepressionConcordance between PGx phenotypes and opioid (Acute Pain and Chronic Pain) and SSRI (Depression) medications.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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