Stroke, AcuteHDSSNCT03330652
Health Disparities in Stroke Patients and Their Families: a Longitudinal Multicenter Study (HDSS)
An observational study of Stroke, Acute, run by Sheba Medical Center at 4 sites in Israel.
Trial summary
The meeting point of the patient and his/her immediate family with the health care system is complicated and traumatic. While having to deal with medicalization geared towards providing evidence-based and cost-effective medical care, the patient expects comprehensive, holistic care tailored to his/her needs, during… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute
- How many people
- 600 participants
- Where
- 4 sitesIsrael
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 800 stroke patients/spouces hospitalized at 4 medical centers, and a close family member, will be recruited during one calendar year.
Who may be able to join
- Acute stroke
- Caregiver of patient who's an immediate family member
Who cannot join
- Inability to communicate
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Neurologic Department, Barzilai Medical Center
Ashkelon
Neurologic Department, Soroka Medical Center
Beersheba
Neurologic Department, El Hagalil Medical Center
Nahariya
Neurologic Department, Sheba Medical Center
Ramat Gan, 52621
About this study
Official title: Identifying Health Disparities and Health Services Gaps by Following Stroke Patients and Their Family Care-givers to Explore Their Needs and Expectations: A Multi-center Longitudinal Study
The meeting point of the patient and his/her immediate family with the health care system is complicated and traumatic. While having to deal with medicalization geared towards providing evidence-based and cost-effective medical care, the patient expects comprehensive, holistic care tailored to his/her needs, during hospitalization or in the community. A survey of 800 stroke patients and their caregiver during the 1st year following acute stroke hospitalization will explore their unmet needs.
Read the detailed description
Background: The meeting point of the patient with the health care system is complicated and traumatic. The patient's autonomy over physical health becomes diminished. The patient and his family need to deal with medicalization geared towards providing evidence-based medical care, while attempting to be cost-efficient. The patient expects comprehensive, holistic care tailored to his/her needs, during hospitalization or in the community.
Objectives: To characterize the patient's and his/her family's needs and expectations from the medical system, following an acute medical event involving hospitalization and community care treatment; to analyze the gaps between these needs and the actual treatment provided.
Working hypotheses: Certain needs and expectations of patients and their families are unrecognized and unmet by the medical system; more deprived population groups can be identified, where the gap between needs and service provided is exceptionally great.
Type of research and methods of data collection: Prospective cohort study. Method(s) of data collection: 800 stroke patients hospitalized at 4 medical centers: Tel Hashomer, Soroka, Asaf-Harofeh, and Naharia, and a close family member (caregiver), will be recruited during one calendar year. These medical centers reflect the heterogeneity of the population, it's ethnic diversity, and the periphery vs. the central areas of the country of Israel. Personal details will be recorded, and informed consent forms signed. The patients will be telephone-interviewed 3-4 months after acute hospitalization, 6-8 months, and after one year, to assess their functionality, coping with bureaucracy, availability and accessibility (financial and cultural), disease management, continuity of treatment, number of caregivers, quality of life, depression, cognitive function, care received by the medical system, "patient at the center" assessment.
Uniqueness and relevance to the National health Insurance Law: Assessment of patient's experience (and his caregivers) in the first year after hospitalization due to stroke, with emphasis on inequality between patients based on socio-economic factors. The assumption is that the gap between expectations and needs of patient and family from the medical system and actual service provided by the system is even bigger among populations who depend more on the system for support.
Among the Ministry of Health's 6 pillars of health is reinforcement of the perception of "patient-centered care" which aims to map out gaps, reasons and challenges in putting this objective into practice. Findings of this research will enable decision makers to efficiently allocate resources and funds to needy populations, thus reducing gaps, lowering use of the medical system and lowering costs incurred by the system.
- Conditions
- Stroke, Acute
- Keywords
- Quality of life, Cognitive function, Mental state, Functional capacity, EQ5D, HADS, Barthel Index, mRS
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
"patient at the center" assessment
coping with bureaucracy, availability and accessibility (financial and cultural), disease management, continuity of treatment
Measured: 12 months after acute stroke
Secondary outcomes (4)
Change over the year of follow up in quality of life
Quality of life will be measured using the European Quality of life 5 Dimention (EQ5D) questionnaire. Scores range from 0-15 where 15 is the worst score
Measured: 4, 8, 12 months after acute stroke
Change over the year of follow up in mental health
Mental health will be evaluated for anxiety and depression using the Hospital and Anxiety Disease Scale (HADS). Score range 0-21 for each anxiety and depression subscales. 21 means worst score.
Measured: 4, 8, 12 months after acute stroke
Change over the year of follow up in functional capacity
Functional capacity of the stroke patient will be measured using the Barthel index. Scores range 0-100 where 0 means worst dissability.
Measured: 4, 8, 12 months after acute stroke
Change over the year of follow up in burden of care
Burden of care as it is experienced by the caregiver of the stroke patient will be evaluated by the Zarit questionnaire. A scale of 0-88 where 88 means the most severe burden
Measured: 4, 8, 12 months after acute stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Israel National Institute for Health Policy and Health Services Research
- Responsible party
- Principal investigator, Dr. Rachel Dankner, Sheba Medical Center
- Investigators
- Rachel S Dankner, MD, MPH, Principal investigator, The Gertner Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330652
- Sponsor's protocol ID
- SHEBA-16-2912-RD-CTIL
- Acronym
- HDSS
- Status last verified
- Aug 2020
- First submitted
- 15 Oct 2017
- Last updated
- 16 Dec 2022
- Results posted
- 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 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Health Disparities and Health Services Gaps by Following Stroke Patients and Their Family Care-givers to Explore Their Needs and Expectations: A Multi-center Longitudinal Study
- ClinicalTrials.gov ID
- NCT03330652
- Acronym / sponsor ID
- HDSS / SHEBA-16-2912-RD-CTIL
- Conditions
- Stroke, Acute
- Keywords
- Quality of life, Cognitive function, Mental state, Functional capacity, EQ5D, HADS, Barthel Index, mRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Israel National Institute for Health Policy and Health Services Research
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Nov 2017 (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 meeting point of the patient and his/her immediate family with the health care system is complicated and traumatic. While having to deal with medicalization geared towards providing evidence-based and cost-effective medical care, the patient expects comprehensive, holistic care tailored to his/her needs, during hospitalization or in the community. A survey of 800 stroke patients and their caregiver during the 1st year following acute stroke hospitalization will explore their unmet needs.
Detailed description
Background: The meeting point of the patient with the health care system is complicated and traumatic. The patient's autonomy over physical health becomes diminished. The patient and his family need to deal with medicalization geared towards providing evidence-based medical care, while attempting to be cost-efficient. The patient expects comprehensive, holistic care tailored to his/her needs, during hospitalization or in the community.
Objectives: To characterize the patient's and his/her family's needs and expectations from the medical system, following an acute medical event involving hospitalization and community care treatment; to analyze the gaps between these needs and the actual treatment provided.
Working hypotheses: Certain needs and expectations of patients and their families are unrecognized and unmet by the medical system; more deprived population groups can be identified, where the gap between needs and service provided is exceptionally great.
Type of research and methods of data collection: Prospective cohort study. Method(s) of data collection: 800 stroke patients hospitalized at 4 medical centers: Tel Hashomer, Soroka, Asaf-Harofeh, and Naharia, and a close family member (caregiver), will be recruited during one calendar year. These medical centers reflect the heterogeneity of the population, it's ethnic diversity, and the periphery vs. the central areas of the country of Israel. Personal details will be recorded, and informed consent forms signed. The patients will be telephone-interviewed 3-4 months after acute hospitalization, 6-8 months, and after one year, to assess their functionality, coping with bureaucracy, availability and accessibility (financial and cultural), disease management, continuity of treatment, number of caregivers, quality of life, depression, cognitive function, care received by the medical system, "patient at the center" assessment.
Uniqueness and relevance to the National health Insurance Law: Assessment of patient's experience (and his caregivers) in the first year after hospitalization due to stroke, with emphasis on inequality between patients based on socio-economic factors. The assumption is that the gap between expectations and needs of patient and family from the medical system and actual service provided by the system is even bigger among populations who depend more on the system for support.
Among the Ministry of Health's 6 pillars of health is reinforcement of the perception of "patient-centered care" which aims to map out gaps, reasons and challenges in putting this objective into practice. Findings of this research will enable decision makers to efficiently allocate resources and funds to needy populations, thus reducing gaps, lowering use of the medical system and lowering costs incurred by the system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 800 stroke patients/spouces hospitalized at 4 medical centers, and a close family member, will be recruited during one calendar year.
Key inclusion criteria (2 listed)
- Acute stroke
- Caregiver of patient who's an immediate family member
Key exclusion criteria (1 listed)
- Inability to communicate
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
"patient at the center" assessment
Time frame: 12 months after acute stroke
coping with bureaucracy, availability and accessibility (financial and cultural), disease management, continuity of treatment
4 secondary outcomes
Change over the year of follow up in quality of life
Time frame: 4, 8, 12 months after acute stroke
Change over the year of follow up in mental health
Time frame: 4, 8, 12 months after acute stroke
Change over the year of follow up in functional capacity
Time frame: 4, 8, 12 months after acute stroke
Change over the year of follow up in burden of care
Time frame: 4, 8, 12 months after acute stroke
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 16 Dec 2022.
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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.
Rachel S Dankner, MD, MPH principal investigator
The Gertner Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Sheba Medical Center at 4 sites 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 2 inclusion and 1 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 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
"patient at the center" assessment (time frame: 12 months after acute stroke). 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 2022.