StrokeNCT06096831
Living With Stroke - Sustainable Utilization of Healthcare Services
An observational study of Stroke and Cerebrovascular Disorders, run by University of Haifa at 1 site in Israel.
Trial summary
The proposed study will generate a national mapping of healthcare utilization patterns in people post-stroke in the chronic phase living in the community; examine the associations between individual-level characteristics, health outcomes and healthcare utilization; and will describe patients' perspectives on their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Cerebrovascular Accident
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Nov 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Post-stroke patients living in the community. At least one year after the stroke occurred. An estimated number of approximately 40,000 patients nationwide (Part 1) and 240 patients hospitalized at the 'Carmel' Medical Center (Part 2\&3).
Who may be able to join
- People diagnosed with stroke (First stroke occurred between 2010-2022)
- At least one year after the event
- Living in the community
- Aged 18 and above
- Insured by HMO (Clalit health services)
Who cannot join
- Stroke chronicity of less than a year
- Diagnosis of TIA (Transient Ischemic Attack)
- Inclusion Criteria for the cross-sectional and qualitative study (Parts 2\&3):
- People diagnosed with stroke
- Hospitalized for a first stroke at the 'Carmel' Medical Center between 2010-2022
- Understand Hebrew/ Arabic/ Russian in a way that allows them to understand the consent form and answer the survey questions.
Show all 10Show fewer
- Exclusion Criteria for the cross-sectional and qualitative study (Parts 2\&3):
- Stroke chronicity of less than a year the study
- Transient ischemic attack (TIA)
- Patients who have a guardian, a nursing condition as a result of diseases other than stroke or other serious background diseases that impair function, people with communication difficulties that do not allow answering questionnaires or to be interviewed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The proposed study will generate a national mapping of healthcare utilization patterns in people post-stroke in the chronic phase living in the community; examine the associations between individual-level characteristics, health outcomes and healthcare utilization; and will describe patients' perspectives on their needs for health services and their experiences of using them.
The study will use mixed-methods methodology (quantitative and qualitative) and will proceed in three parts. In part 1, data will be extracted retrospectively from electronic medical records of of Clalit Health Services, covering all patients with a stroke diagnosis. In part 2, a sub-sample of 240 patients will be asked to answer standardized questionnaires. In part 3, a sub-sample of 20 participants will participate in in-depth, semi-structured interviews.
Read the detailed description
Stroke is the leading cause of long-term disability worldwide. Although healthcare services can have a crucial role in mitigating the long-term multidimensional disabilities caused by stroke, most medical and rehabilitative services are currently directed towards the acute phase of the disease up to six months after its occurrence. Healthcare services in the chronic phase are inadequately structured, and stroke survivors in the community report lack of continuity of care and a sense of abandonment. Long-term utilization patterns of healthcare service by post-stroke persons are unknown.
Based on data to be collected from people in the chronic post-stroke phase living in the community, the study goals are to (1) generate a national mapping of patterns of healthcare utilization; (2) examine associations between individual-level characteristics and healthcare utilization; and (3) describe patients' perspectives on their needs for health services and their experience of using them.
A 'Mixed methods' research combining qualitative and quantitative methods will be conducted.The research will include 3 parts: Part 1 of the study is retrospective study based on data extracting from electronic medical records of Clalit Health Services on healthcare utilization of people post-stroke (app. 40,000 people); Part 2 is a cross-sectional study based on a sub-group of 240 people post-stroke that will be asked to answer standardized questionnaires on face to face meeting aimed to capture individual determinants of healthcare utilization; Part 3 will include in-depth interviews with 20 people post-stroke to capture patients' perspectives on their post-stroke healthcare needs and their experience of using healthcare services.
- Keywords
- Post-stroke, Healthcare utilization, Continuity of care, Rehabilitation
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-Stroke patients at chronic phase living in the community | The data will be extracted from medical records of all people who are at least one year after a stroke, live in the community and are insured by Health maintenence Organization (HMO).In the first part we expect to extract data of approximately 40,000 patients . In the second part, a sub sample of 240 patients will be recruited to answer standardized questionnaires. In the third part, a sub-sample from part 2, of 20 people will be interviewed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visits to a neurologist
Monitoring the number of annual visits to a neurologist in the chronic phase of the disease.
Extraction and analysis of data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Measured: 1 year
Use of physical therapy services
Monitoring the number of annual visits to physical therapy services in the chronic phase of the disease.
Extraction and analysis of data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Measured: 1 year
Stroke impact Scale - SIS 3.0
The SIS-3.0 questionnaire evaluate how the stroke has impacted patients' health and life.
It composed of 59 items investigating 8 domains (strength, hand function, mobility, activities of daily living, emotion, memory, communication, social participation) and also assesses the degree of recovery from the stroke. Range of scores is 0-100. Each item is scaling by a 5-point scale from 1 to 5. The questionnaire will be evaluated for a sub-sample of 250 patients.
Measured: 1 hour
Visits to the emergency medicine center and urgent hospitalization data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Monitoring the number of annual visits to the emergency medicine center and the number of urgent hospitalization in the chronic phase of the disease.
Extraction and analysis of data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Measured: 1 year
Secondary outcomes (3)
Use of occupational therapy services
Monitoring the number of annual visits to occupational therapy services in the chronic phase of the disease.
Extraction and analysis of data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Measured: 1 year
Use of speech-language therapy services
Monitoring the number of annual visits to speech-language therapy services in the chronic phase of the disease.
Extraction and analysis of data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Measured: 1 year
Recurrent stroke
Follow-up of recurrent stroke in the chronic phase of the disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Nov 2023
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Clalit Health Services, Carmel Medical Center
- Responsible party
- Sponsor
- Investigators
- Michal Kafri, PhD, Principal investigator, University of HaifaSivan Bloch, M.D, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096831
- Sponsor's protocol ID
- CMC-0082-22
- Status last verified
- Oct 2025
- First submitted
- 8 Oct 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Stroke - Sustainable Utilization of Healthcare Services
- ClinicalTrials.gov ID
- NCT06096831
- Acronym / sponsor ID
- CMC-0082-22
- Keywords
- Post-stroke, Healthcare utilization, Continuity of care, Rehabilitation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Clalit Health Services, Carmel Medical Center
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Oct 2023 (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.
The proposed study will generate a national mapping of healthcare utilization patterns in people post-stroke in the chronic phase living in the community; examine the associations between individual-level characteristics, health outcomes and healthcare utilization; and will describe patients' perspectives on their needs for health services and their experiences of using them.
The study will use mixed-methods methodology (quantitative and qualitative) and will proceed in three parts. In part 1, data will be extracted retrospectively from electronic medical records of of Clalit Health Services, covering all patients with a stroke diagnosis. In part 2, a sub-sample of 240 patients will be asked to answer standardized questionnaires. In part 3, a sub-sample of 20 participants will participate in in-depth, semi-structured interviews.
Detailed description
Stroke is the leading cause of long-term disability worldwide. Although healthcare services can have a crucial role in mitigating the long-term multidimensional disabilities caused by stroke, most medical and rehabilitative services are currently directed towards the acute phase of the disease up to six months after its occurrence. Healthcare services in the chronic phase are inadequately structured, and stroke survivors in the community report lack of continuity of care and a sense of abandonment. Long-term utilization patterns of healthcare service by post-stroke persons are unknown.
Based on data to be collected from people in the chronic post-stroke phase living in the community, the study goals are to (1) generate a national mapping of patterns of healthcare utilization; (2) examine associations between individual-level characteristics and healthcare utilization; and (3) describe patients' perspectives on their needs for health services and their experience of using them.
A 'Mixed methods' research combining qualitative and quantitative methods will be conducted.The research will include 3 parts: Part 1 of the study is retrospective study based on data extracting from electronic medical records of Clalit Health Services on healthcare utilization of people post-stroke (app. 40,000 people); Part 2 is a cross-sectional study based on a sub-group of 240 people post-stroke that will be asked to answer standardized questionnaires on face to face meeting aimed to capture individual determinants of healthcare utilization; Part 3 will include in-depth interviews with 20 people post-stroke to capture patients' perspectives on their post-stroke healthcare needs and their experience of using healthcare services.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Stroke patients at chronic phase living in the community | – | –The data will be extracted from medical records of all people who are at least one year after a stroke, live in the community and are insured by Health maintenence Organization (HMO).In the first part we expect to extract data of approximately 40,000 patients . In the second part, a sub sample of 240 patients will be recruited to answer standardized questionnaires. In the third part, a sub-sample from part 2, of 20 people will be interviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-stroke patients living in the community. At least one year after the stroke occurred. An estimated number of approximately 40,000 patients nationwide (Part 1) and 240 patients hospitalized at the 'Carmel' Medical Center (Part 2\&3).
Key inclusion criteria (5 listed)
- People diagnosed with stroke (First stroke occurred between 2010-2022)
- At least one year after the event
- Living in the community
- Aged 18 and above
- Insured by HMO (Clalit health services)
Key exclusion criteria (10 listed)
- Stroke chronicity of less than a year
- Diagnosis of TIA (Transient Ischemic Attack)
- People diagnosed with stroke
- Hospitalized for a first stroke at the 'Carmel' Medical Center between 2010-2022
- Understand Hebrew/ Arabic/ Russian in a way that allows them to understand the consent form and answer the survey questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visits to a neurologist
Time frame: 1 year
Monitoring the number of annual visits to a neurologist in the chronic phase of the disease. Extraction and analysis of data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Use of physical therapy services
Time frame: 1 year
Monitoring the number of annual visits to physical therapy services in the chronic phase of the disease. Extraction and analysis of data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Stroke impact Scale - SIS 3.0
Time frame: 1 hour
The SIS-3.0 questionnaire evaluate how the stroke has impacted patients' health and life. It composed of 59 items investigating 8 domains (strength, hand function, mobility, activities of daily living, emotion, memory, communication, social participation) and also assesses the degree of recovery from the stroke. Range of scores is 0-100. Each item is scaling by a 5-point scale from 1 to 5. The questionnaire will be evaluated for a sub-sample of 250 patients.
Visits to the emergency medicine center and urgent hospitalization data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
Time frame: 1 year
Monitoring the number of annual visits to the emergency medicine center and the number of urgent hospitalization in the chronic phase of the disease. Extraction and analysis of data from Clalit's electronic medical records (EMR) of all insured patients who had a stroke. An estimated number of 40,000 patients post-stroke.
3 secondary outcomes
Use of occupational therapy services
Time frame: 1 year
Use of speech-language therapy services
Time frame: 1 year
Recurrent stroke
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Michal Kafri, PhD principal investigator
University of Haifa
Sivan Bloch, M.D principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cerebrovascular Disorders, run by University of Haifa at 1 site in Israel.
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 5 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visits to a neurologist (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.