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Health Disparities in Stroke Patients and Their Families: a Longitudinal Multicenter Study (HDSS) (HDSS)

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ClinicalTrials.gov Identifier: NCT03330652
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
Israel National Institute for Health Policy and Health Services Research
Information provided by (Responsible Party):
Dr. Rachel Dankner, Sheba Medical Center

Brief 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 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.

Condition or disease
Stroke, Acute

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : October 31, 2021



Primary Outcome Measures :
  1. "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


Secondary Outcome Measures :
  1. Change over the year of follow up in quality of life [ Time Frame: 4, 8, 12 months after acute stroke ]
    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

  2. Change over the year of follow up in mental health [ Time Frame: 4, 8, 12 months after acute stroke ]
    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.

  3. Change over the year of follow up in functional capacity [ Time Frame: 4, 8, 12 months after acute stroke ]
    Functional capacity of the stroke patient will be measured using the Barthel index. Scores range 0-100 where 0 means worst dissability.

  4. Change over the year of follow up in burden of care [ Time Frame: 4, 8, 12 months after acute stroke ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
800 stroke patients/spouces hospitalized at 4 medical centers, and a close family member, will be recruited during one calendar year.
Criteria

Inclusion Criteria:

  • Acute stroke
  • Caregiver of patient who's an immediate family member

Exclusion Criteria:

  • Inability to communicate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330652


Contacts
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Contact: Rachel S Dankner, MD, MPH +97237731405 racheld@gertner.health.gov.il
Contact: Angela Chetrit, MBA angelac@gertner.health.gov.il

Locations
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Israel
Neurologic Department, Barzilai Medical Center Recruiting
Ashkelon, Israel
Contact: Ron Milo, MD       rmilo@bezeqint.net   
Contact: Nir Michal       nirm@bmc.gov.il   
Neurologic Department, Soroka Medical Center Terminated
Be'er Sheva, Israel
Neurologic Department, El Hagalil Medical Center Terminated
Nahariya, Israel
Neurologic Department, Sheba Medical Center Completed
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Israel National Institute for Health Policy and Health Services Research
Investigators
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Principal Investigator: Rachel S Dankner, MD, MPH The Gertner Institute
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Responsible Party: Dr. Rachel Dankner, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03330652    
Other Study ID Numbers: SHEBA-16-2912-RD-CTIL
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Rachel Dankner, Sheba Medical Center:
Quality of life
Cognitive function
Mental state
Functional capacity
EQ5D
HADS
Barthel Index
mRS
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases