NCT04901637

Brief Summary

Stroke is one of the major causes of neurological disability in adults globally. Fifteen million patients suffer from stroke annually throughout the world, from which 5 million had to continue to live with a major disability. Especially in developing and non-developing countries, it contributes significantly to the mortality and morbidity. The improvements in medical care of acute stroke, especially in a specialized stroke unit setting, reduced overall mortality of the disease. However, the general prognosis of stroke survivors did not improve accordingly, so that many survivors have to deal with different forms of disability. Following a stroke, patients usually suffer from variable degrees of disability. They require acute treatment at an inpatient setting and extensive assistance throughout their recovery at home. Most stroke survivors depend on informal caregivers, who usually is a family member (eg, spouse) providing unpaid care for the patient.Caregivers are usually unprepared and unfit for such a support after discharge. And as a result, they may experience a decline in their physical and mental health status, social life and general well-being The current study sought to examine the musculoskeletal problems of the informal caregivers in relation with the physical condition and the degree of disability of the patient they are caring. To our knowledge this study can be considered as the first of its kind by evaluating the symptoms of the caregiver from their viewpoint and relates the level of their symptoms to the level of incapacity of the stroke patient.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 30, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

May 21, 2021

Last Update Submit

June 3, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Extended Nordic Musculoskeletal Questionnaire

    The effect of musculoskeletal symptoms during the last 6 months was evaluated using the NMQ-E, which is a one-page survey evaluating nine body regions: hand/wrist, elbow, shoulder, neck, upper back, low back, hip/thigh, knee and foot/ankle.Responses were provided as 'trouble, including ache, pain and discomfort'.Only musculoskeletal symptoms (affecting joints, muscles, and bones) were asked about in order to rule out other symptoms like neuropathic or abdominal pain.

    1 interview day

  • Caregiver Burden Inventory

    BI is a self-administered 24-item questionnaire with five domains: time dependency, developmental, physical, social, and emotional pressures. All objects are scored on a 5-point Likert scale, with 0 being the least disruptive (not at all disruptive) and 4 being the most disruptive (very disruptive). The global score is calculated by adding the subscale scores together. Greater caregiver burden is shown by higher ratings

    1 interview day

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were eligible if they had a stroke according the WHO definition at least 6 months prior, who need assistance with the activities of daily life(ADL) and are older than 18 years of age and the informal caregivers over the age of 18, who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance were included in the study.

You may qualify if:

  • For stroke survivors:
  • Patients were eligible if they had a stroke according the WHO definition at least 6 months prior,
  • Who need assistance with the activities of daily life(ADL)
  • Older than 18 years of age
  • For caregivers:
  • Older than 18 years of age
  • Who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance

You may not qualify if:

  • For caregivers:
  • Who are above the age of 65

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital,

Istanbul, Kucukcekmece, 39750, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Sahbaz T, Medin-Ceylan C. Stroke severity to determine musculoskeletal symptoms in family caregivers. Rev Lat Am Enfermagem. 2023 Oct 9;31:e4004. doi: 10.1590/1518-8345.6725.4004. eCollection 2023.

MeSH Terms

Conditions

StrokeCaregiver Burden

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Tugba Sahbaz, MD

    University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tugba Sahbaz, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 21, 2021

First Posted

May 25, 2021

Study Start

May 30, 2019

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations