NCT06096831

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

October 8, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 16, 2025

Status Verified

October 1, 2025

Enrollment Period

2.3 years

First QC Date

October 8, 2023

Last Update Submit

December 8, 2025

Conditions

Keywords

Post-strokeHealthcare utilizationContinuity of careRehabilitation

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    1 year

Secondary Outcomes (3)

  • Use of occupational therapy services

    1 year

  • Use of speech-language therapy services

    1 year

  • Recurrent stroke

    1 year

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, 3498838, Israel

Location

MeSH Terms

Conditions

StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michal Kafri, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR
  • Sivan Bloch, M.D

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2023

First Posted

October 24, 2023

Study Start

November 15, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 16, 2025

Record last verified: 2025-10

Locations