StrokeNCT04278794
Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity
A study testing Transitional Care Stroke Intervention (TCSI) in people with Stroke, run by McMaster University at 2 sites in Canada.
Trial summary
Stroke is the leading cause of death and adult disability in Canada. Sixty percent of these older adults (> 65 years) will return to their homes after a stroke and will require ongoing rehabilitation. About 92% of older adults have two or more chronic conditions. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Transitional Care Stroke Intervention (TCSI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Nov 2020to 5 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 55 years or greater
- hospitalized for stroke and receiving in-patient rehabilitation
- diagnosed with at least 2 or more chronic conditions
- will be discharged to the community from in-patient rehabilitation (not hospital or long-term care)
- not planning to move out of the study catchment area in the next 6 months
- referred to outpatient stroke rehabilitation services
- capable of providing informed consent, or have a substitute decision-maker who is capable and able to provide informed consent on his/her behalf
- competent in English, or has an interpreter who is competent in English
Who cannot join
- less than 55 years of age
- fewer than two chronic conditions
- planned discharge to hospital or long-term care facility
- cognitively impaired with no substitute decision maker who is capable to provide consent
- not competent in English with no interpreter
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton Health Sciences
Hamilton, Ontario, L8S 4L8
Hotel Dieu Shaver
Saint Catherines, Ontario
About this study
Official title: Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity: A Pragmatic Trial of an Outpatient-based Virtual Transitional Care Intervention
Stroke is the leading cause of death and adult disability in Canada. Sixty percent of these older adults (> 65 years) will return to their homes after a stroke and will require ongoing rehabilitation. About 92% of older adults have two or more chronic conditions. These patients often require services from a number of providers in a number of settings and are therefore, susceptible to fragmented health care when transitioning from hospital to home. New interventions are needed to improve the quality of care as patients move from hospital to home after a stroke. The proposed research project will examine the impact of a new intervention on patient/caregiver health, patient/caregiver and provider experience and costs, compared to usual health care services. The new intervention will be coordinated by a system navigator and consists of four core components: 1) development of a comprehensive discharge plan, 2) up to 6 home visits (supported by phone calls) by an interprofessional outpatient team, 3) monthly case conferences including the interprofessional care team who will discuss and focus on the patient's goals and care needs, and 4) linkages to other healthcare and community services. This multidisciplinary project will build on our previous study, which provided the groundwork for further study of this new intervention.
Read the detailed description
The overall purpose of this pragmatic randomized controlled trial (RCT) is to adapt, implement and evaluate a novel person- and family-centred Transitional Care Stroke Intervention (TCSI) for older adults (> 55 years) with stroke and multimorbidity (>2 chronic conditions) and their caregivers. The TCSI is a theory- and evidence-based 6-month intervention designed to improve the health, experience, and quality of transitioning from hospital-to-home for this vulnerable population. An effectiveness-implementation hybrid type I design will be used, which will focus primarily on examining the effectiveness of the TCSI on quadruple aim outcomes: (i) patient and caregiver health outcomes, (ii) patient and caregiver experience, (iii) provider/manager experience, and (iv) patient healthcare service use costs, and will also evaluate implementation outcomes (e.g., barriers, facilitators, fidelity). Our earlier pre-post study provided evidence to support the feasibility, acceptability and preliminary effectiveness of the TCSI on reducing hospital readmissions and emergency department visits (for any cause). These improvements were achieved at no additional cost. The key components of the TCSI in this earlier study included home visits supported by telephone calls by an interprofessional team (IP), patient-centered care planning, and care coordination/recruitment. The following enhancements to the TCSI will be included in the trial: 1) integrating the navigator role across the care continuum, 2) testing the TCSI with a larger sample and more rigorous (RCT) design, 3) enhancing patient self-management, and 4) evaluating the impact of the intervention on caregiver health outcomes and experience. These improvements alongside the inclusion of additional evaluation measures will enable rigorous evaluation of the TCSI and position it for future scale-up and spread
- Conditions
- Stroke
- Being tested
- Transitional Care Stroke Intervention (TCSI)
- Keywords
- Older adults, Multimorbidity, Transitional care, Virtual care, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Care Stroke Intervention (TCSI)Other
Core components:
- Comprehensive Hospital Discharge Plan. The Care Coordinator will meet with staff in the in-patient unit along with patients and their caregivers to develop and implement a comprehensive discharge plan.
- Structured home visits and telephone support. As part of the structured home visits and telephone support, a member of the IP team will provide up to 6 home visits over 6 months. The team will provide: screening and assessment; medication review and reconciliation; self-management support; education; and caregiver assessment.
- Monthly IP case conferences. 6 monthly IP team case conferences will be held to discuss goals identified by the patient, collectively develop a plan of care, and identify needs.
- Linkages to services. Facilitate timely follow-up with the primary care provider and build relationships with local health and social service providers. These referrals and links will provide the foundation for continued use post-intervention.
| Study group | Role | What they receive |
|---|---|---|
| Transitional Care Stroke Intervention (TCSI) | Experimental | Participants randomly assigned to the intervention group will be offered the intervention in addition to usual care provided by in-patient and outpatient stroke rehabilitation services. The TCSI is a 6-month stroke transitional care intervention, provided in addition to usual stroke care, that includes four core components: comprehensive hospital discharge plan, structured home visits and telephone support, monthly intraprofessional case conferences, and linkages to primary care and other healthcare and community services. The TCSI will be delivered by an interprofessional team of care providers at the study site, including an occupational therapist, registered nurse, speech language pathologist, physical therapist, and social worker from a hospital-based outpatient stroke rehabilitation setting. Receives: Other: Transitional Care Stroke Intervention (TCSI) |
| Control | No intervention | Usual care provided by in-patient and out-patient stroke rehabilitation services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any hospital readmission for any cause within 6 months
The Health and Social Services Utilization Inventory (HSSUI) will be used to identify patients with any readmission to hospital for any cause within 6 months from study enrolment. The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services from a societal perspective. The question in the HSSUI pertaining to any hospital readmission for any cause will be: "Have you been readmitted to the hospital in the past 6-months?" (Yes / No).
Measured: 6-months
Secondary outcomes (11)
Change in health-related quality of life - mental health
The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess change in mental health. The tool consists of 12 questions that measure functional health and well-being from the participant's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, mental health) by which a psychometrically-based physical component summary and mental component summary score can be calculated. Response options include the frequency of feeling a certain way or behaviour across 3 or 5 categories (e.g., 'all of the time'). Total scale range 0-100. Higher scores represent a better mental health - health-related quality of life. This will be assessed in patients and caregivers.
Measured: Baseline; 6 months
Change in health-related quality of life - physical health
The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess change in physical health. The tool consists of 12 questions that measure functional health and well-being from the participant's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, mental health) by which a psychometrically-based physical component summary and mental component summary score can be calculated. Response options include the frequency of feeling a certain way or behaviour across 3 or 5 categories (e.g., 'all of the time'). Total scale range 0-100. Higher scores represent a better physical health - health-related quality of life. This will be assessed in patients and caregivers.
Measured: Baseline; 6 months
Change in self-efficacy
The Stroke Self-Efficacy Questionnaire (SSEQ) will be used to assess change in self-efficacy of the patient. The SSEQ is a 13-item self-report scale measuring self-efficacy judgements in specific domains of functioning post stroke. Individuals rate their belief in their ability to achieve each of the 13 items on a 10-point scale, where 0 = not at all confident to 10 = very confident. A higher score represents a higher self-efficacy. This will be measured in patients.
Measured: Baseline; 6 months
Change in depressive symptoms
The Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10) will be used to assess change in depressive symptoms and symptom severity. This tool has been used in prior studies of older adults with mood disorders, has a high degree of reliability and validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations. Participants will be asked about the way they have felt or behaved in response to 10 statements such as 'I was happy'. Response options ask participants to select the frequency they have felt or behaved during the last week, ranging from 'rarely or none of the time (less than 1 day)', 'some or a little of the time (1-2 days)', 'occasionally or moderate (3-4 days)', to 'most or all of the time (5-7 days)'. Scale range: 0 - 30. Higher scores represent more depressive symptoms. This will be measured in patients.
Measured: Baseline; 6 months
Change in anxiety
The Generalized Anxiety Disorder 7-Item (GAD-7) will be used to assess change in anxiety symptoms and severity of symptoms. The GAD-7 is a 7-item tool that asks about the type and frequency of being bothered by a list of problems. Response options include 'not at all', 'several days', 'more than half the days', or 'nearly every', over the last two weeks. Scale range: 0 - 21. Higher scores represent more anxiety. This will be measured in patients.
Measured: Baseline; 6 months
Change in stroke physical function
The Stroke Impact Scale (SIS-16) will be used to assess change in physical functional capacity following stroke. The SIS is a self-report questionnaire that evaluates disability and health-related quality of life following stroke. Scores range from 16 to 80, with a higher score indicating a higher level of functional capacity. This will be measured in patients.
Measured: Baseline; 6 months
Change in community integration
The Community Integration Questionnaire (CIQ) will be used to assess change in level of integration in community. The CIQ consists of 15 items relevant to home integration (H), social integration (S), and productive activities (P). Scores range from 0-29 with a higher score indicating a higher level of community integration. This will be measured in patients.
Measured: Baseline; 6 months
Change in use of health and social services
The HSSUI will be used to assess change in use of health and social services of patients and caregivers. The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services, from a societal perspective. The HSSUI provides information on different categories of use including acute care service use such as emergency department visits and hospitalizations, use of nursing and allied health professionals, and visits to family doctors and specialists. Change in the use of health and social services will be assessed for patients and caregivers using the HSSUI.
Measured: Baseline; 6 months
Change in caregiver strain
The Modified Caregiver Strain Index (MCSI) will be used to assess change in caregiver strain. This tool will ask caregivers a list of 13 activities that they may have found to be difficult such as sleeping, physical strain, financial strain, personal plans, and work and family adjustments as a result of the caregiver role. Response options include 'yes' according to two levels, either 'yes, on a regular basis' or 'yes, sometimes', or alternatively, 'no'. Scale range: 0 - 26. Higher scores represent more strain. This will be assessed in caregivers.
Measured: Baseline; 6 months
Relative risk of any hospital readmission for any cause within 6 months
The Health and Social Services Utilization Inventory (HSSUI) will be used to assess any readmission to hospital for any cause (patient). The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services from a societal perspective. The HSSUI provides information on different categories of use including acute care service use such as emergency department visits and hospitalizations, use of nursing and allied health professionals, and visits to family doctors and specialists. The relative risk of any hospitalization within six months for any cause will be examined for patients in the intervention group compared to patients in the control group.
Measured: Baseline; 6 months
Time to any hospital readmission for any cause within 6 months
Data from the Institute for Clinical and Evaluative Sciences (IC/ES) will be used to assess the time to any hospital readmission for any cause for patients. The Hospital Discharge Abstract Database (DAD) within IC/ES will be used to measure readmission.
Measured: Baseline; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start30 Nov 2020
- Primary completion28 Apr 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effectiveness-implementation hybrid type I design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Hamilton Health Sciences Corporation, Health Quality Ontario, Canadian Frailty Network, Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Maureen Markle-Reid, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278794
- Sponsor's protocol ID
- CIHR-419061
- Status last verified
- Mar 2023
- First submitted
- 5 Feb 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Markle-Reid M, Fisher K, Walker KM, Beauchamp M, Cameron JI, Dayler D, Fleck R, Gafni A, Ganann R, Hajas K, Koetsier B, Mahony R, Pollard C, Prescott J, Rooke T, Whitmore C. The stroke transitional care intervention for older adults with stroke and multimorbidity: a multisite pragmatic randomized controlled trial. BMC Geriatr. 2023 Oct 24;23(1):687. doi: 10.1186/s12877-023-04403-1.
PubMed 37872479
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Hospital-to-home Transitions for Older Adults With Stroke and Multimorbidity: A Pragmatic Trial of an Outpatient-based Virtual Transitional Care Intervention
- ClinicalTrials.gov ID
- NCT04278794
- Acronym / sponsor ID
- CIHR-419061
- Conditions
- Stroke
- Keywords
- Older adults, Multimorbidity, Transitional care, Virtual care, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Hamilton Health Sciences Corporation, Health Quality Ontario, Canadian Frailty Network, Ontario Ministry of Health and Long Term Care
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the leading cause of death and adult disability in Canada. Sixty percent of these older adults (> 65 years) will return to their homes after a stroke and will require ongoing rehabilitation. About 92% of older adults have two or more chronic conditions. These patients often require services from a number of providers in a number of settings and are therefore, susceptible to fragmented health care when transitioning from hospital to home. New interventions are needed to improve the quality of care as patients move from hospital to home after a stroke. The proposed research project will examine the impact of a new intervention on patient/caregiver health, patient/caregiver and provider experience and costs, compared to usual health care services. The new intervention will be coordinated by a system navigator and consists of four core components: 1) development of a comprehensive discharge plan, 2) up to 6 home visits (supported by phone calls) by an interprofessional outpatient team, 3) monthly case conferences including the interprofessional care team who will discuss and focus on the patient's goals and care needs, and 4) linkages to other healthcare and community services. This multidisciplinary project will build on our previous study, which provided the groundwork for further study of this new intervention.
Detailed description
The overall purpose of this pragmatic randomized controlled trial (RCT) is to adapt, implement and evaluate a novel person- and family-centred Transitional Care Stroke Intervention (TCSI) for older adults (> 55 years) with stroke and multimorbidity (>2 chronic conditions) and their caregivers. The TCSI is a theory- and evidence-based 6-month intervention designed to improve the health, experience, and quality of transitioning from hospital-to-home for this vulnerable population. An effectiveness-implementation hybrid type I design will be used, which will focus primarily on examining the effectiveness of the TCSI on quadruple aim outcomes: (i) patient and caregiver health outcomes, (ii) patient and caregiver experience, (iii) provider/manager experience, and (iv) patient healthcare service use costs, and will also evaluate implementation outcomes (e.g., barriers, facilitators, fidelity). Our earlier pre-post study provided evidence to support the feasibility, acceptability and preliminary effectiveness of the TCSI on reducing hospital readmissions and emergency department visits (for any cause). These improvements were achieved at no additional cost. The key components of the TCSI in this earlier study included home visits supported by telephone calls by an interprofessional team (IP), patient-centered care planning, and care coordination/recruitment. The following enhancements to the TCSI will be included in the trial: 1) integrating the navigator role across the care continuum, 2) testing the TCSI with a larger sample and more rigorous (RCT) design, 3) enhancing patient self-management, and 4) evaluating the impact of the intervention on caregiver health outcomes and experience. These improvements alongside the inclusion of additional evaluation measures will enable rigorous evaluation of the TCSI and position it for future scale-up and spread
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Effectiveness-implementation hybrid type I design.
| Arm | Type | Receives |
|---|---|---|
| Transitional Care Stroke Intervention (TCSI) | Experimental | Other: Transitional Care Stroke Intervention (TCSI)Participants randomly assigned to the intervention group will be offered the intervention in addition to usual care provided by in-patient and outpatient stroke rehabilitation services. The TCSI is a 6-month stroke transitional care intervention, provided in addition to usual stroke care, that includes four core components: comprehensive hospital discharge plan, structured home visits and telephone support, monthly intraprofessional case conferences, and linkages to primary care and other healthcare and community services. The TCSI will be delivered by an interprofessional team of care providers at the study site, including an occupational therapist, registered nurse, speech language pathologist, physical therapist, and social worker from a hospital-based outpatient stroke rehabilitation setting. |
| Control | No intervention | –Usual care provided by in-patient and out-patient stroke rehabilitation services. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 55 years or greater
- hospitalized for stroke and receiving in-patient rehabilitation
- diagnosed with at least 2 or more chronic conditions
- will be discharged to the community from in-patient rehabilitation (not hospital or long-term care)
- not planning to move out of the study catchment area in the next 6 months
Key exclusion criteria (5 listed)
- less than 55 years of age
- fewer than two chronic conditions
- planned discharge to hospital or long-term care facility
- cognitively impaired with no substitute decision maker who is capable to provide consent
- not competent in English with no interpreter
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 |
|---|---|---|
| Transitional Care Stroke Intervention (TCSI)Core components: 1. Comprehensive Hospital Discharge Plan. The Care Coordinator will meet with staff in the in-patient unit along with patients and their caregivers to develop and implement a comprehensive discharge plan. 2. Structured home visits and telephone support. As part of the structured home visits and telephone support, a member of the IP team will provide up to 6 home visits over 6 months. The team will provide: screening and assessment; medication review and reconciliation; self-management support; education; and caregiver assessment. 3. Monthly IP case conferences. 6 monthly IP team case conferences will be held to discuss goals identified by the patient, collectively develop a plan of care, and identify needs. 4. Linkages to services. Facilitate timely follow-up with the primary care provider and build relationships with local health and social service providers. These referrals and links will provide the foundation for continued use post-intervention. | Other | Transitional Care Stroke Intervention (TCSI) |
Primary outcome
Any hospital readmission for any cause within 6 months
Time frame: 6-months
The Health and Social Services Utilization Inventory (HSSUI) will be used to identify patients with any readmission to hospital for any cause within 6 months from study enrolment. The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services from a societal perspective. The question in the HSSUI pertaining to any hospital readmission for any cause will be: "Have you been readmitted to the hospital in the past 6-months?" (Yes / No).
11 secondary outcomes
Change in health-related quality of life - mental health
Time frame: Baseline; 6 months
Change in health-related quality of life - physical health
Time frame: Baseline; 6 months
Change in self-efficacy
Time frame: Baseline; 6 months
Change in depressive symptoms
Time frame: Baseline; 6 months
Change in anxiety
Time frame: Baseline; 6 months
Change in stroke physical function
Time frame: Baseline; 6 months
Change in community integration
Time frame: Baseline; 6 months
Change in use of health and social services
Time frame: Baseline; 6 months
Change in caregiver strain
Time frame: Baseline; 6 months
Relative risk of any hospital readmission for any cause within 6 months
Time frame: Baseline; 6 months
Time to any hospital readmission for any cause within 6 months
Time frame: Baseline; 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 37872479Markle-Reid M, Fisher K, Walker KM, Beauchamp M, Cameron JI, Dayler D, Fleck R, Gafni A, Ganann R, Hajas K, Koetsier B, Mahony R, Pollard C, Prescott J, Rooke T, Whitmore C. The stroke transitional care intervention for older adults with stroke and multimorbidity: a multisite pragmatic randomized controlled trial. BMC Geriatr. 2023 Oct 24;23(1):687. doi: 10.1186/s12877-023-04403-1.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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.
Maureen Markle-Reid, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional Care Stroke Intervention (TCSI) in people with Stroke, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Any hospital readmission for any cause within 6 months (time frame: 6-months). 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 NCT04278794, which also lists 1 linked publication.
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 23 Mar 2023.