Trial · NCT02507505
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Death or Inability to Walk 10 Feet or Across a Room Without Human Assistance | Approximately 60 days after Randomization | Will be assessed via telephone interview |
| Secondary | Overall Health and Disability | Approximately 60, 180, and 365 days after randomization | Will be assessed via the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The 12-item WHODAS 2.0 scale measures disability in six functional domains (cognition, mobility, self-care, social interaction, life activities, and community participation). Scores range from 0 to 100, with lower scores indicating lower degrees of disability. |
| Secondary | Ability to Return to Home | Approximately 60, 180, and 365 days after randomization | Will be assessed via telephone interview. Measure assessed as death or new transition to nursing home residence at each time point. |
| Secondary | Chronic Pain | Approximately 60, 180, and 365 days after randomization | Will be assessed via the Numeric Rating Scale (NRS) and the need for prescription medications as evaluated during telephone interview. NRS values range from 0 to 10, with higher values indicating greater pain. |
| Secondary | Cognitive Function | Baseline and approximately 60, 180, and 365 days after randomization | Will be assessed via Short Blessed Test (SBT); SBT values range from 0 to 28, with higher scores indicating greater degrees of cognitive impairment. |
| Secondary | All-cause Mortality | Approximately 60, 180, and 365 days after randomization | Will be assessed via telephone interview and National Death Index (NDI) search |
| Secondary | Need for Assistive Devices for Walking | Approximately 60, 180, and 365 days after randomization | Will be assessed via telephone interview |
| Secondary | Acute Postoperative Pain | Before surgery and daily through postoperative day 3 or day of discharge, whichever occurs first | Will be assessed via in-person interview using numeric rating scale (NRS). NRS values range from 0 to 10, with greater values indicating worse pain. |
| Secondary | Satisfaction With Care | Postoperative day 3 or day of discharge, whichever occurs first | Will be assessed via Bauer Patient Satisfaction Questionnaire. Data reported here corresponds to a response of "dissatisfied" or "very dissatisfied" to one or more of 5 Bauer questionnaire items assessing the following domains: information given by anesthesiologist before surgery; waking up from anesthesia; pain therapy after surgery; treatment of nausea and vomiting after surgery; care provided by department of anesthesia in general. |
| Secondary | Postoperative Delirium | Baseline and daily through postoperative day 3 or day of discharge, whichever occurs first | Will be assessed via 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) assessment tool. Any positive 3D-CAM screen over the first 3 postoperative days in a patient with a negative pre-randomization screen was counted as a case of incident delirium. |
| Secondary | Inpatient Mortality | During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first | Will be assessed via medical chart review. Data reported here on inpatient mortality. |
| Secondary | Major Inpatient Morbidity | During initial hospitalization until day of discharge or 30 days after randomization, whichever occurs first | Indicates occurrence of any of 12 complications based on medical record review: Myocardial infarction; Nonfatal cardiac arrest; Stroke; Pneumonia; Pulmonary edema; Pulmonary embolism; Unplanned postoperative intubation; Surgical-site infection; Urinary tract infection; Any return to the operating room; Critical care admission; Acute kidney injury. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02507505/registered