NCT03330652

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 16, 2022

Status Verified

August 1, 2020

Enrollment Period

4 years

First QC Date

October 15, 2017

Last Update Submit

December 15, 2022

Conditions

Keywords

Quality of lifeCognitive functionMental stateFunctional capacityEQ5DHADSBarthel IndexmRS

Outcome Measures

Primary Outcomes (1)

  • "patient at the center" assessment

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

    12 months after acute stroke

Secondary Outcomes (4)

  • Change over the year of follow up in quality of life

    4, 8, 12 months after acute stroke

  • Change over the year of follow up in mental health

    4, 8, 12 months after acute stroke

  • Change over the year of follow up in functional capacity

    4, 8, 12 months after acute stroke

  • Change over the year of follow up in burden of care

    4, 8, 12 months after acute stroke

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Inability to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Neurologic Department, Barzilai Medical Center

Ashkelon, Israel

Location

Neurologic Department, Soroka Medical Center

Beersheba, Israel

Location

Neurologic Department, El Hagalil Medical Center

Nahariya, Israel

Location

Neurologic Department, Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rachel S Dankner, MD, MPH

    The Gertner Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2017

First Posted

November 6, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 16, 2022

Record last verified: 2020-08

Locations