Trial · NCT02478359
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths | 12 months following randomization | Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site |
| Secondary | Number of Deaths Among Participants | 12 months following randomization | Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site |
| Secondary | Number of Participants With All-cause Hospitalizations | 12 months following randomization | Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site |
| Secondary | Number of Participants With All-cause Emergency Department Visits | 12 months following randomization | Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site |
| Secondary | Number of Participants With All-cause Observation Stays | 12 months following randomization | Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site |
| Secondary | Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 12 months following randomization | Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site |
| Secondary | Number of Participants With COPD Exacerbation | 12 months following randomization | COPD exacerbations were ascertained via pharmacy records and utilization data. An outpatient COPD exacerbation will be defined as a care touch (clinic visit, phone, or secure message encounter) with a diagnosis of COPD accompanied by a prescription of either an oral steroid or an antibiotic within 2 days |
| Secondary | COPD Assessment Test, CAT - 12 Months | 12 months | The reported mean change between the baseline and 12 Months scores for the Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Score range is 0-40. A negative change score indicates fewer symptoms. |
| Secondary | Physical Activity | 12 months | Patients were categorized as being: completely inactive (0 mins/week), insufficiently active (1-149 mins/week) or active, meeting national physical activity recommendations (\>150 mins/week) of moderate to vigorous physical activity. |
| Secondary | Personal Health Questionnaire, PHQ8 - 12 Months | 12 months | The reported mean change between the baseline and 12 Months scores. Score range is 0-24. A negative change score indicates less depressive symptoms. |
| Secondary | General Anxiety Disorder, GAD-7 - 12 Months | 12 months | The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety. |
| Secondary | PROMIS-10 HRQL , Physical Health - 12 Months | 12 months | The reported mean change between the baseline and 12 Months T-scores. Score range is 16-68. A positive change score reflects better physical functioning. |
| Secondary | PROMIS-10 HRQL , Mental Health - 12 Months | 12 months | The reported mean change between the baseline and 12 Months T-scores. Score range is 21-68. A positive change score reflects better mental health. |
| Secondary | Diastolic Blood Pressure | 12 months following randomization | Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \>100F and those obtained in urgent care were excluded. |
| Secondary | Systolic Blood Pressure | 12 months following randomization | Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of \>100F and those obtained in urgent care were excluded. |
| Secondary | HbA1c Levels | 12 months following randomization | HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization |
| Secondary | LDL Levels | 12 months following randomization | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Secondary | HDL Levels | 12 months following randomization | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Secondary | Total Cholesterol Levels | 12 months following randomization | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Secondary | Triglycerides Levels | 12 months post randomization | Cholesterol levels were obtained from values closest to the 12 months post randomization |
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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