Trial · NCT02588664
Comprehensive Post-Acute Stroke Services
NCT02588664, Not applicable, Completed, Wake Forest University Health Sciences; results first posted 2021-06-11
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Comprehensive Post-Acute Stroke Services. Trials, record NCT02588664. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02588664
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comprehensive Post-Acute Stroke Services
- NCT number
- NCT02588664
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 6,024 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Stroke, Transient Ischemic Attack
- Interventions
- COMPASS Intervention
- First posted
- 2015-10-28
- Last updated
- 2021-06-11
- Results first posted
- 2021-06-11
- Limitations and caveats
Only 58% of intervention hospitals staffed TC clinics continuously. Patient-level barriers were also present and included preference to see primary care providers, affordability, and transportation. Only 35% of patients enrolled through Intervention hospitals received the COMPASS TC Intervention.
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Stroke Impact Scale (SIS-16) | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 3476 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure | score on a scale | MEAN |
| SECONDARY | Modified Caregiver Strain Index | post-stroke day 90 | Each enrolled patient was asked to identify a caregiver. A total of 4208 caregivers were identified and asked to complete the Caregiver Questionnaire. A total of 1228 caregivers completed the Caregiver Survey. However, to account for missing data, we utilized inverse probability weight to perform the analysis so the final analysis included was 4208 for this outcome. | score on a scale | MEAN |
| SECONDARY | Self-reported General Health | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 3169 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Modified Rankin Score | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 3209 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure. | score on a scale | MEDIAN |
| SECONDARY | Number of Participants Physically Active and Not Physically Active | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 2968 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With or Without Depression | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 2,774 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cognition (MoCA 5-min Protocol) | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 2,728 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Medication Adherence (Morisky Green Levine Scale-4) | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 2,730 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure. | score on a scale | MEDIAN |
| SECONDARY | Number of Participants With or Without Falls | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 3,055 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Self-reported Fatigue (PROMIS Fatigue Instrument) | post-stroke day 90 | Of the 5,882 that were enrolled in the study, 2,721 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure. | score on a scale | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stroke Impact Scale (SIS-16) | Usual Care | 79.9 | Standard Deviation 21.4 | score on a scale | |
| Stroke Impact Scale (SIS-16) | COMPASS Intervention | 80.6 | Standard Deviation 21.1 | score on a scale | |
| Modified Caregiver Strain Index | Usual Care | 21.9 | Standard Deviation 23.1 | score on a scale | |
| Modified Caregiver Strain Index | COMPASS Intervention | 21.9 | Standard Deviation 23.5 | score on a scale | |
| Self-reported General Health | Usual Care | 65.4 | Standard Deviation 28.8 | score on a scale | |
| Self-reported General Health | COMPASS Intervention | 66.2 | Standard Deviation 28.8 | score on a scale | |
| Modified Rankin Score | Usual Care | 1 | Inter-Quartile Range 0 to 3 | score on a scale | |
| Modified Rankin Score | COMPASS Intervention | 1 | Inter-Quartile Range 0 to 3 | score on a scale | |
| Number of Participants Physically Active and Not Physically Active | Usual Care | Yes Physically Active (150 min/week of physical activity or more) | 488 | Participants | |
| Number of Participants Physically Active and Not Physically Active | COMPASS Intervention | Yes Physically Active (150 min/week of physical activity or more) | 431 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Usual Care | 3,193 | |
| Overall Study | STARTED | COMPASS Intervention | 2,689 | |
| Overall Study | COMPLETED | Usual Care | 1,832 | |
| Overall Study | COMPLETED | COMPASS Intervention | 1,644 | |
| Overall Study | NOT COMPLETED | Usual Care | 1,361 | |
| Overall Study | NOT COMPLETED | COMPASS Intervention | 1,045 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Usual Care | 56 | 3,193 |
| Total, all-cause mortality | COMPASS Intervention | 55 | 2,689 |
| Total, other adverse events | Usual Care | 0 | 0 |
| Total, other adverse events | COMPASS Intervention | 0 | 0 |
| Total, serious adverse events | Usual Care | 0 | 3,137 |
| Total, serious adverse events | COMPASS Intervention | 0 | 2,689 |
Source ClinicalTrials.gov
Papers23
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| COMPASS Intervention vs Usual Care: Number of Subjects With Claims-based All-cause Hospital Readmissions | Trial comparisons |
| COMPASS Intervention vs Usual Care: Number of Subjects With Claims-based All-cause Hospital Readmissions | Trial comparisons |
| COMPASS Intervention vs Usual Care: Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF) | Trial comparisons |
| COMPASS Intervention vs Usual Care: Number of Subjects With Claims-based Emergency Department Visits | Trial comparisons |
| COMPASS Intervention vs Usual Care: Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes | Trial comparisons |
| COMPASS Intervention vs Usual Care: deaths from any cause | Trial comparisons |
| COMPASS Intervention vs Usual Care: Number of Subjects With Claims-based All-cause Hospital Readmissions | Trial comparisons |
| COMPASS Intervention vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02588664
GET https://conductscience.org/api/trials/v1/NCT02588664/registered?page=2