Trial · NCT00313144
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL 'General Health (GH)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL 'Vitality (VT)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. |
| Primary | HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The MCS is a summary scale of the dimensions vitality, social functioning, role emotional, and mental health Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. |
| Primary | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Baseline to 12 months | SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Baseline to 12 months | SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Primary | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Baseline to 24 months | SF-36 Scores- baseline thru 24 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| Secondary | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | Baseline to 24 Months | Number of participants with indicated number of ER visits (0, 1, 2, 3, ≥4 ER visits per participant) during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Secondary | Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits' | One year prior to baseline to 24 months post-baseline | Mean number of ER visits one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Secondary | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | Baseline to 24 Months | Number of participants with indicated number of hospitalizations during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Secondary | Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital' | Baseline to 24 months | Mean LOS during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Secondary | Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics' | One year prior to baseline to 24 months post-baseline | Number of participants taking antibiotics one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Secondary | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | One year prior to baseline to 24 months post-baseline | Number of antibiotic courses (i.e. number of antibiotic prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Secondary | Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses' | One year prior to baseline to 24 months post-baseline | Number of participants receiving steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
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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