Acute StrokeMISTTNCT02653170
Michigan Stroke Transitions Trial
A study testing SCM and SCM and VSSP in people with Acute Stroke, run by Michigan State University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- SCM and SCM and VSSP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Sparrow Health System
Lansing, Michigan, 48912
Saint Joseph Mercy Health System
Ypsilanti, Michigan, 48197
About this study
Official title: The Michigan Stroke Transitions Trial (MISTT): Improving Care Transitions for Acute Stroke Patients Through a Patient-centered Home Based Case Management Program
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.
Read the detailed description
To improve care transitions for acute stroke patients this pragmatic, community-based, randomized, open clinical trial will test the efficacy of two separate but complementary interventions against usual care. The parallel group design will compare the following 3 groups:
- Usual care
- Stroke Case Manager (SCM): trained social workers who provide home based case management services
- SCM services plus access to the Virtual Stroke Support Portal (VSSP) an online information and support resource.
This patient-level randomized trial will be conducted at 3 Michigan hospitals and will enroll a total of 315 acute stroke patients (105 per intervention group). Each hospital will enroll cases over an 18 month period. Randomization will be balanced within each hospital to ensure that an equal number of patients are assigned to the 3 groups. If the patient identifies a primary caregivers they will be contacted and enrollment accordingly.
The trial interventions begin once the patient returns home (= Day 1) and end 3 months later (= Day 90). Outcomes data will be collected by telephone at baseline (= Day 7) and at Day 90. Subjects who are enrolled but do not go home within 1 month (because they remain in a rehabilitation or Skilled Nursing Facility) will be dropped and replaced by new patients. Two primary patient-level outcome measures include the Patient Activation Measure (PAM), a measure of self-efficacy, and the PROMIS-10, a global quality of life scale. Two primary caregiver-level outcome measures include the Bakas Caregiving Outcomes Scale (BCOS) and depression (PHQ-9).
By adhering to the principles of pragmatic trials, this trial is designed to inform typical U.S. clinical practice, with outcomes that are directly relevant to patients and caregivers. Specifically, this trial is designed to answer the practical question of whether the transitional care experience of stroke patients and caregivers can be improved by social workers who visit the home, and whether their effectiveness can be enhanced by a comprehensive patient-centered online resource.
- Conditions
- Acute Stroke
- Being tested
- SCM, SCM and VSSP
- Keywords
- acute stroke, care transitions, patient engagement, patient education, caregivers, social workers
- Medical subject headings
- Stroke, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCMOther
One intervention (SCM) is provided. Stroke Case Managers (SCMs) will conduct 2 home visits; the first within 72-96 hours and the other after 30-days of returning home. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted if needed. Home visit activities include:
- Biopsychosocial assessment of patient and caregiver needs.
- Set up appointments.
- Assist scheduling appointments with primary care physician and other medical providers.
- Promote medication adherence through medication tool kits, pill organizers and other aids.
- Facilitate patient and caregiver engagement and activation.
- Facilitate access to social and community services.
SCM and VSSPOther
SCM: Stroke Case Managers (SCMs) will conduct home visits at 72-96 hours and after 30-days. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Activities include:
- Biopsychosocial assessment of patient and caregiver needs.
- Set up appointments.
- Assist scheduling appointments with primary care physician and other medical providers.
- Promote medication adherence through medication tool kits, pill organizers and other aids.
- Facilitate patient and caregiver engagement and activation.
- Facilitate access to social and community services.
VSSP: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:
- Contact list of care team members.
- Access to hospital patient portal.
- Stroke education materials, resources, and guidelines.
- Access to Michigan 2-1-1 services.
- Medication information and adherence tools.
- Patient and Caregiver support networks.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients in this group will receive the hospitals' usual transitional care approach. |
| SCM | Experimental | One intervention is provided:
1. SCM (Stroke Case manager): a trained social worker who provides in-home case management services. Receives: Other: SCM |
| SCM and VSSP | Experimental | Two interventions are provided:
1. SCM (Stroke Case manager): a trained social worker who provides in-home case management services. Plus:
2. VSSP (Virtual Stroke Support Portal): Access and training in the use of the VSSP: a purpose-built, online, patient-centered information and support resource. Receives: Other: SCM and VSSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient)
Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Physical Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).
Measured: 7 days and 90 days post discharge
Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient)
Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Mental Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).
Measured: 7 days and 90 days post discharge
Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)
Instrument designed to measure perceived caregiver life changes in response to providing care to stroke survivors. Bakas is a 15-item measure using a rating scale with 7 points ranging from -3 (changed for the worse) to +3 (changed for the best); responses are converted to a 1-7 scale and summed (range 15-105). Higher scores indicate more positive changes resulting from caregiving experience whereas lower scores indicate negative changes.
Measured: 7 days and 90 days post discharge
Secondary outcomes (2)
Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)
Patient questionnaire to assess knowledge, skills, and self-efficacy for managing one's own healthcare. Patient Activation Measure is a 13-item survey using a five-point Likert scale (strongly disagree, disagree, agree, strongly agree, NA) whose response items are summed and converted to an activation score ranging from 0-100. Higher scores indicate a higher level of activation.
Measured: 7 days and 90 days post discharge
Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)
The Patient Health Questionnaire (PHQ-9) measures severity of depression symptoms. PHQ-9 is a 9-item measure using a four-point Likert scale (not at all, several days, more than half the days, nearly every day). Response items are summed (range 0-27) with higher scores indicating the respondent is experiencing more symptoms of depression.
Measured: 7 days and 90 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Trinity Health Michigan, Sparrow Health System, Massachusetts General Hospital
- Responsible party
- Principal investigator, Mathew Reeves, Michigan State University
- Investigators
- Mathew J Reeves, BVSc, PhD, Principal investigator, Professor, Department of Epidemiology and Biostatistics, College of Human Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653170
- Sponsor's protocol ID
- 135457
- Other IDs
- HIS-1310-07420-01
- Acronym
- MISTT
- Status last verified
- Jul 2019
- First submitted
- 9 Apr 2015
- Last updated
- 16 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reeves MJ, Hughes AK, Woodward AT, Freddolino PP, Coursaris CK, Swierenga SJ, Schwamm LH, Fritz MC. Improving transitions in acute stroke patients discharged to home: the Michigan stroke transitions trial (MISTT) protocol. BMC Neurol. 2017 Jun 17;17(1):115. doi: 10.1186/s12883-017-0895-1.
PubMed 28623892Reeves MJ, Fritz MC, Woodward AT, Hughes AK, Coursaris CK, Swierenga SJ, Nasiri M, Freddolino PP. Michigan Stroke Transitions Trial. Circ Cardiovasc Qual Outcomes. 2019 Jul;12(7):e005493. doi: 10.1161/CIRCOUTCOMES.119.005493. Epub 2019 Jul 12.
PubMed 31296043
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Michigan Stroke Transitions Trial (MISTT): Improving Care Transitions for Acute Stroke Patients Through a Patient-centered Home Based Case Management Program
- ClinicalTrials.gov ID
- NCT02653170
- Acronym / sponsor ID
- MISTT / 135457
- Conditions
- Acute Stroke
- Keywords
- acute stroke, care transitions, patient engagement, patient education, caregivers, social workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, Trinity Health Michigan, Sparrow Health System, Massachusetts General Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 16 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To improve care transitions for acute stroke patients this pragmatic, community-based, randomized, open clinical trial will test the efficacy of two separate but complementary interventions against usual care. The parallel group design will compare the following 3 groups:
- Usual care
- Stroke Case Manager (SCM): trained social workers who provide home based case management services
- SCM services plus access to the Virtual Stroke Support Portal (VSSP) an online information and support resource.
This patient-level randomized trial will be conducted at 3 Michigan hospitals and will enroll a total of 315 acute stroke patients (105 per intervention group). Each hospital will enroll cases over an 18 month period. Randomization will be balanced within each hospital to ensure that an equal number of patients are assigned to the 3 groups. If the patient identifies a primary caregivers they will be contacted and enrollment accordingly.
The trial interventions begin once the patient returns home (= Day 1) and end 3 months later (= Day 90). Outcomes data will be collected by telephone at baseline (= Day 7) and at Day 90. Subjects who are enrolled but do not go home within 1 month (because they remain in a rehabilitation or Skilled Nursing Facility) will be dropped and replaced by new patients. Two primary patient-level outcome measures include the Patient Activation Measure (PAM), a measure of self-efficacy, and the PROMIS-10, a global quality of life scale. Two primary caregiver-level outcome measures include the Bakas Caregiving Outcomes Scale (BCOS) and depression (PHQ-9).
By adhering to the principles of pragmatic trials, this trial is designed to inform typical U.S. clinical practice, with outcomes that are directly relevant to patients and caregivers. Specifically, this trial is designed to answer the practical question of whether the transitional care experience of stroke patients and caregivers can be improved by social workers who visit the home, and whether their effectiveness can be enhanced by a comprehensive patient-centered online resource.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients in this group will receive the hospitals' usual transitional care approach. |
| SCM | Experimental | Other: SCMOne intervention is provided: 1. SCM (Stroke Case manager): a trained social worker who provides in-home case management services. |
| SCM and VSSP | Experimental | Other: SCM and VSSPTwo interventions are provided: 1. SCM (Stroke Case manager): a trained social worker who provides in-home case management services. Plus: 2. VSSP (Virtual Stroke Support Portal): Access and training in the use of the VSSP: a purpose-built, online, patient-centered information and support resource. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCMOne intervention (SCM) is provided. Stroke Case Managers (SCMs) will conduct 2 home visits; the first within 72-96 hours and the other after 30-days of returning home. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted if needed. Home visit activities include: 1. Biopsychosocial assessment of patient and caregiver needs. 2. Set up appointments. 3. Assist scheduling appointments with primary care physician and other medical providers. 4. Promote medication adherence through medication tool kits, pill organizers and other aids. 5. Facilitate patient and caregiver engagement and activation. 6. Facilitate access to social and community services. | Other | SCM |
| SCM and VSSPSCM: Stroke Case Managers (SCMs) will conduct home visits at 72-96 hours and after 30-days. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Activities include: 1. Biopsychosocial assessment of patient and caregiver needs. 2. Set up appointments. 3. Assist scheduling appointments with primary care physician and other medical providers. 4. Promote medication adherence through medication tool kits, pill organizers and other aids. 5. Facilitate patient and caregiver engagement and activation. 6. Facilitate access to social and community services. VSSP: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes: 1. Contact list of care team members. 2. Access to hospital patient portal. 3. Stroke education materials, resources, and guidelines. 4. Access to Michigan 2-1-1 services. 5. Medication information and adherence tools. 6. Patient and Caregiver support networks. | Other | SCM and VSSP |
Primary outcome
Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient)
Time frame: 7 days and 90 days post discharge
Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Physical Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).
Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient)
Time frame: 7 days and 90 days post discharge
Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Mental Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).
Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)
Time frame: 7 days and 90 days post discharge
Instrument designed to measure perceived caregiver life changes in response to providing care to stroke survivors. Bakas is a 15-item measure using a rating scale with 7 points ranging from -3 (changed for the worse) to +3 (changed for the best); responses are converted to a 1-7 scale and summed (range 15-105). Higher scores indicate more positive changes resulting from caregiving experience whereas lower scores indicate negative changes.
2 secondary outcomes
Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)
Time frame: 7 days and 90 days post discharge
Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)
Time frame: 7 days and 90 days post discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28623892Reeves MJ, Hughes AK, Woodward AT, Freddolino PP, Coursaris CK, Swierenga SJ, Schwamm LH, Fritz MC. Improving transitions in acute stroke patients discharged to home: the Michigan stroke transitions trial (MISTT) protocol. BMC Neurol. 2017 Jun 17;17(1):115. doi: 10.1186/s12883-017-0895-1.
- Derived from this study: PubMed 31296043Reeves MJ, Fritz MC, Woodward AT, Hughes AK, Coursaris CK, Swierenga SJ, Nasiri M, Freddolino PP. Michigan Stroke Transitions Trial. Circ Cardiovasc Qual Outcomes. 2019 Jul;12(7):e005493. doi: 10.1161/CIRCOUTCOMES.119.005493. Epub 2019 Jul 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathew J Reeves, BVSc, PhD principal investigator
Professor, Department of Epidemiology and Biostatistics, College of Human Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCM and SCM and VSSP in people with Acute Stroke, run by Michigan State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) (time frame: 7 days and 90 days post discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653170, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.