Trial · NCT02588664
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stroke Impact Scale (SIS-16) | post-stroke day 90 | 16-item survey to assess the difficulty level of performing basic physical activities; scores range from 0-100; higher scores correspond to more favorable outcomes |
| Secondary | Modified Caregiver Strain Index | post-stroke day 90 | 13-item survey to measure strain that caregivers may experience; scores range from 0-100; higher scores indicate more caregiver burden |
| Secondary | Self-reported General Health | post-stroke day 90 | Self-reported general health is a single question to rate their general health. Responses on a 5-point Likert Scale (Excellent, Very Good, Good, Fair, or Poor) will be analyzed as a continuous variable. Scores range from 95-15 with a higher score indicating better health. |
| Secondary | Modified Rankin Score | post-stroke day 90 | to measure the degree of disability or dependence; scores range from 0-6; higher scores correspond to less favorable outcomes |
| Secondary | Number of Participants Physically Active and Not Physically Active | post-stroke day 90 | Participants are asked whether they walked continuously for at least 10 minutes on any of the last seven days, how many of those days they walked continuously for at least 10 minutes and how many minutes they walked, on average, each day. The physical activity endpoint will be self-reported total number of minutes walked during the past seven days. |
| Secondary | Number of Participants With or Without Depression | post-stroke day 90 | Based on answers to Patient Health Questionnaire 2-Item (PHQ-2) which is a 2-item questionnaire to determine the frequency of depressed mood; scores range from 0-6; higher scores correspond to less favorable outcomes |
| Secondary | Cognition (MoCA 5-min Protocol) | post-stroke day 90 | 4-item questionnaire to determine vascular cognitive impairment; scores range from 0-30; higher scores are more favorable |
| Secondary | Medication Adherence (Morisky Green Levine Scale-4) | post-stroke day 90 | 4 items with yes/no response options; scores range from 0-4; higher scores correspond to less medication adherence |
| Secondary | Number of Participants With or Without Falls | post-stroke day 90 | Participants are asked 4 questions to determine whether they have fallen (yes versus no) since hospital discharge, whether or not the fall resulted in a doctor/emergency room visit, whether they have fallen multiple times since discharge, and how many times they have fallen since discharge. Analysis of falls will be based on incidence of any fall since hospital discharge (no falls versus at least one fall). |
| Secondary | Self-reported Fatigue (PROMIS Fatigue Instrument) | post-stroke day 90 | 4-question instrument to determine level of fatigue; higher scores correspond to less favorable outcomes; The total raw score is obtained by summing individual question scores and has a range of 4-20. For analysis, raw scores are translated into T-scores which range from 33.7 - 75.8. The T-score rescales the raw score into a standardized score with a mean of 50 and a SD of 10. |
| Secondary | Satisfaction With Care | post-stroke day 90 | 6 questions to determine satisfaction with care; scores range from 0-100; higher scores correspond to higher satisfaction of care |
| Secondary | Number of Participants Who Do or Do Not Monitor Blood Pressure at Home | post-stroke day 90 | Participants are asked 2 questions to determine whether they monitor their blood pressure at home (yes or no) and, if they answer in the affirmative, how frequently (daily, weekly, and monthly). Home blood pressure monitoring was analyzed as a dichotomous endpoint (monitoring with any frequency versus no monitoring). |
| Secondary | Self-reported Blood Pressure | post-stroke day 90 | 1 question to determine self-reported blood pressure. Self-reported systolic and diastolic BP will each be analyzed as a continuous endpoint. In addition, self-reported systolic and diastolic BP will be used to create a dichotomous hypertension endpoint (systolic BP \>= 140 versus systolic BP \< 140). |
| Secondary | Number of Subjects With Claims-based All-cause Hospital Readmissions | post-stroke day 30 | |
| Secondary | Number of Subjects With Claims-based All-cause Hospital Readmissions | post-stroke day 90 | |
| Secondary | Number of Subjects With Claims-based All-cause Hospital Readmissions | post-discharge year 1 | |
| Secondary | Number of Subjects With All-cause Mortality Using NC State Death Index | post-stroke day 90 | Deaths within 90 days of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death. |
| Secondary | Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare | post-discharge year 1 | Deaths within 1 year of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death. |
| Secondary | Number of Subjects With Claims-based Emergency Department Visits | post-discharge year 1 | |
| Secondary | Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF) | post-discharge year 1 |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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GET https://conductscience.org/api/trials/v1/NCT02588664/registered