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CompletedNCT03330652HDSSUpdated Dec 16, 2022

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

An observational study in Stroke, Acute, sponsored by Sheba Medical Center. Completed at 4 sites in Israel. Per ClinicalTrials.gov, last updated 2022-12-16.

Sponsored by Sheba Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Stroke, Acute

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Keywords

  • Quality of life
  • Cognitive function
  • Mental state
  • Functional capacity
  • EQ5D
  • HADS
  • Barthel Index
  • mRS
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability to communicate
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. "patient at the center" assessment

    coping with bureaucracy, availability and accessibility (financial and cultural), disease management, continuity of treatment

    Time frame: 12 months after acute stroke

Secondary outcomes

  1. 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

    Time frame: 4, 8, 12 months after acute stroke

  2. 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.

    Time frame: 4, 8, 12 months after acute stroke

  3. 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.

    Time frame: 4, 8, 12 months after acute stroke

  4. 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

    Time frame: 4, 8, 12 months after acute stroke

06

Study locations

4 sites
  • Neurologic Department, Barzilai Medical Center
    Ashkelon, Israel
  • Neurologic Department, Soroka Medical Center
    Be'er Sheva, Israel
  • Neurologic Department, El Hagalil Medical Center
    Nahariya, Israel
  • Neurologic Department, Sheba Medical Center
    Ramat Gan, 52621, Israel
07

Registry details

Key details

Study ID
NCT03330652
Lead sponsor
Sheba Medical Center
Collaborators
Israel National Institute for Health Policy and Health Services Research
Responsible party
Dr. Rachel Dankner (Principal Investigator, Sheba Medical Center) — Principal investigator
First posted
Nov 6, 2017
Start date
Jan 1, 2018
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Dec 16, 2022

Study contacts

Rachel S Dankner, MD, MPH
principal investigator · The Gertner Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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