What is the Burden of Housing in Rural Areas for Individuals With Hemiplegia?

February 2, 2024 updated by: Mustafa Hüseyin Temel, Uskudar State Hospital
Our objective is to examine the impact of residing in urban or rural areas on the utilization of healthcare services, self-efficacy, and quality of life among individuals with hemiplegia in Turkey.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this upcoming cross-sectional study, we will assess patients with hemiplegia who are scheduled to visit the physical medicine and rehabilitation outpatient clinic. Each participant will undergo a personal interview to fulfill the Stroke Self-Efficacy Questionnaire (SSEQ) and Stroke Specific Quality of Life Scale (SS-QOL). We will utilize the hospital database to determine the frequency of emergency department visits, physical medicine and rehabilitation outpatient clinic appointments, and general practitioner clinic visits specifically for hemiplegia in the previous year.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Üsküdar
      • Istanbul, Üsküdar, Turkey, 34000
        • Üsküdar State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Stroke patients who gave written consent to participate.

Description

Inclusion Criteria:

  • Clinical diagnosis of Stroke.
  • Giving consent.

Exclusion Criteria:

  • Not giving consent.
  • Inability to read and comprehend.
  • Severe cognitive impairments or communication difficulties.
  • Severe visual or motor impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Stroke Patients
Stroke patients giving written informed consent.
Other: The Stroke-Specific Quality of Life (SS-QoL) scale
The Stroke-Specific Quality of Life (SS-QoL) scale is a questionnaire-based tool that is used to assess the quality of life of individuals who have experienced a stroke. It was developed to evaluate the impact of stroke on various domains of life, including physical, psychological, and social aspects. The SS-QoL scale contains 49 items, which are organized into 12 domains such as mobility, self-care, work/productivity, language, social roles, and emotional well-being. The scale has been validated and is widely used by healthcare professionals and researchers to assess the effectiveness of interventions and treatments for stroke patients, as well as to evaluate the long-term impact of stroke on their quality of life.
Other: The Stroke Self-Efficacy Questionnaire (SSEQ)
The Stroke Self-Efficacy Questionnaire (SSEQ) is a tool used to measure an individual's perceived self-efficacy or confidence in managing the consequences of a stroke. It consists of 13 items that assess an individual's ability to manage various stroke-related challenges, such as physical, emotional, and social difficulties. The SSEQ is designed to help healthcare professionals and researchers understand how an individual's perceived self-efficacy influences their ability to cope with the consequences of a stroke and manage their recovery effectively. By measuring an individual's perceived self-efficacy, the SSEQ can help identify areas where additional support and interventions may be needed to improve their overall recovery and quality of life.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Stroke Self-Efficacy Questionnaire (SSEQ)
Time Frame: 1 day
The Stroke Self-Efficacy Questionnaire (SSEQ) is a tool used to measure an individual's perceived self-efficacy or confidence in managing the consequences of a stroke. It consists of 13 items that assess an individual's ability to manage various stroke-related challenges, such as physical, emotional, and social difficulties. The SSEQ is designed to help healthcare professionals and researchers understand how an individual's perceived self-efficacy influences their ability to cope with the consequences of a stroke and manage their recovery effectively. By measuring an individual's perceived self-efficacy, the SSEQ can help identify areas where additional support and interventions may be needed to improve their overall recovery and quality of life.
1 day
The Stroke-Specific Quality of Life (SS-QoL) scale
Time Frame: 1 day
The Stroke-Specific Quality of Life (SS-QoL) scale is a questionnaire-based tool that is used to assess the quality of life of individuals who have experienced a stroke. It was developed to evaluate the impact of stroke on various domains of life, including physical, psychological, and social aspects. The SS-QoL scale contains 49 items, which are organized into 12 domains such as mobility, self-care, work/productivity, language, social roles, and emotional well-being. The scale has been validated and is widely used by healthcare professionals and researchers to assess the effectiveness of interventions and treatments for stroke patients, as well as to evaluate the long-term impact of stroke on their quality of life.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar State Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mustafa H Temel, Üsküdar State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BurdenSVO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will be shared by the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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