N/A
N=265
Michigan Stroke Transitions Trial
Acute Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02653170 ↗Enrolled (actual)
265
Serious AEs
3.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) — 0.293; 1.263; 3.663 change in T-score — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SCM (Other); SCM and VSSP (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michigan State University
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) |
0.293; 1.263; 3.663 | 0.025 sig |
| PRIMARY Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient) |
1.187; 0.123; 1.445 | 0.562 |
| PRIMARY Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver) |
1.934; 0.646; 1.961 | 0.789 |
| SECONDARY Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient) |
0.874; -0.777; 5.897 | 0.042 sig |
| SECONDARY Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver) |
-0.919; -1.0100; -0.947 | 0.993 |
Summary
The Michigan Stroke Transitions Trial (MISTT) is a patient-centered randomized control trial that aims to improve the experience of stroke patients after they return home. The MISTT study will test the effect of two complementary interventions against usual care. The two interventions include: a) Stroke Case Managers (SCMs) who are trained social workers, and b) an online informational website or portal. The 12 week intervention period begins when the stroke patient returns home from the hospital or rehab facility. The SCMs will conduct at least 2 home visits with the patient (one within 3-4 days and one around 30 days) along with weekly follow-up telephone calls. Supplemental home visits will be used as necessary over the 12 week period. At the first home visit the social workers will conduct a comprehensive in-home assessment and link patients and caregivers to local resources as necessary. Patients also assigned to the website will have access to a patient-centered online information and support resource called the Virtual Stroke Support Portal (VSSP). The investigators hypothesize that this personalized case management program will reduce patient and caregiver needs, improve quality of life, and decrease caregiver stress. The MISTT study will enroll 315 acute stroke patients discharged from 3 Michigan hospitals and will be completed by the end of 2017.
Eligibility Criteria
Patient Inclusion Criteria:
- A final confirmed hospital diagnosis of acute stroke (ischemic or hemorrhagic).
- Patient living at home pre-stroke.
- Presence of stroke-related deficits at admission (defined as a National Institute of Health Stroke Severity score of >=1).
- Presence of at least mild functional limitations at discharge (defined as a modified Rankin score [mRS] score of >=1), or therapy ordered.
- Discharged directly home (includes patient's residence or that of a family member).
- Discharged to a rehabilitation facility (IRF or SNF) with the expectation of return to home within 4 weeks.
Patient Exclusion Criteria:
- Patients who live more than 50 miles from the hospital (for reasons related to the home visits).
- Patients discharged to nursing home, hospice care or LTCH (Long term care hospital).
- Patients who have clinically documented cognitive deficits or stroke-related impairments including aphasia sufficient to impact the consent process and for whom a proxy respondent is not available.
- Patients who fail the 6-item cognitive screening (SIS-6) for cognitive impairment (score <=4) and for whom a proxy respondent is not available
- Patients enrolled in another acute stroke intervention trial that has a significant impact on the post-acute period (i.e., intensive data collection required of patient during follow-up).
- Limited life expectancy (< 6 months) or significant medical comorbidity likely to impact completion of the study (e.g., severe mental illness, drug or alcohol use or dependence, metastatic cancer).
- Neither the patient nor caregiver speaks English.
Caregiver Inclusion Criteria:
- Age 18 or over.
- Are identified by the stroke patient as the primary caregiver (individual who has primary responsibility for assisting with the patient's care).
- Speaks English.
Data sourced from ClinicalTrials.gov (NCT02653170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.