Virtual Home Visits for Stroke Patients and Their Caregivers (INHABASAEV)

April 11, 2024 updated by: Yasemin Demir, The Scientific and Technological Research Council of Turkey

The Evaluation of the Effectiveness of Virtual Home Visits for Stroke Patients and Their Caregivers as Part of Home Health Services.

The primary aim of this study is to evaluate the effectiveness of virtual home care for stroke patients and their caregivers. The secondary purpose is to evaluate the usability of the application by developing a mobile application for use in virtual home visits.

The study will be carried out using the mixed research model, in which quantitative and qualitative methods are used together. The population of the research will consist of patients and caregivers with the diagnosis of hemorrhage, infarction, cerebrovascular accident and cerebral infarction, who applied to the Antalya Provincial Health Directorate Antalya Training and Research Hospital Home Health Unit, where the study is planned to be conducted. The sample of the study will consist of stroke patients and caregivers who meet the criteria for inclusion in the study. The first phase of the study was designed as a parallel group, single center and single blind randomized controlled trial to evaluate the effectiveness of virtual home visits in terms of time, cost and caregiver competence. The experimental group was the patient/patient relative group who made a virtual home visit, the control group will consist of 48 patients/patient relatives who have been visited face-to-face. In the second phase of the study, semi-structured interview method will be used to determine the views of patients/patient relatives about virtual home visits. In order to evaluate the usability of the developed application, a usability survey will be applied to the group that has visited the virtual home.

With the results of this study, telemedicine applications in home care services will help to increase accessibility to home care services and reduce health care costs.considered to contribute. At the same time, it is expected that the results of the study will contribute to the scientific literature in the field of design and application of telemedicine services, which are developing and spreading

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is one of the leading causes of death in our country, with 22.2%. In addition, stroke, the most common disease diagnosis, has a prevalence of 35%. Treatment of this disease begins in the hospital and continues at home. Treatment and spread over many years. There are barriers due to reasons such as the inability of stroke patients to come to the outpatient clinic, bed dependency, old age, and living outside the central district due to the lack of advanced specialist areas related to stroke in the center and big cities. In addition, the Covid-19 pandemic has made it difficult for the stroke patient to benefit from home health care. In our country, home care services are generally for conical diseases. One of the chronic diseases in the first three of these is stroke patients, whose medical diagnosis is called cerebrovascular disease. Stroke patients constitute an important part of home care services.

Remote healthcare provides many advantages to healthcare professionals and patients with chronic disease diagnosis. Some of these advantages are; TÜSEB Home Health Services Report (2021) states that virtual home visits are used to reduce the risk of transmission of Covid-19 disease during the pandemic. In addition to the many advantages of remote health services, problems such as users' readiness, usability, technology literacy, attitudes, internet access while using remote health services still continue today.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

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 Backup

Study Locations

  • Turkey
      • Antalya, Turkey, 07058
        • Recruiting
        • Yasemin Demi̇r Avci̇
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being willing to participate in the study,
  • Hospitalization with the diagnosis of (stroke, hemorrhage, infarction, cerebrovascular accident and cerebral infarction),
  • Districts of Antalya Training and Research Hospital
  • The patient's * Barthel Activities of Daily Living Index dependency level is complete, severe, moderate, and mildly dependent.
  • For pressure ulcer risk **Braden Risk Assessment Tool
  • For caregivers;
  • Having internet access Being primarily responsible for the care of the patient (who performs the daily activities of the patient during the intervention),
  • The caregiver has internet access,
  • At least one person in the house where the patient lives is using the internet,
  • In the case of more than one caregiver, the most willing caregiver,

Exclusion Criteria:

  • The lack of volunteerism of the stroke patient and family
  • The patient has a history of addiction other than stroke,
  • Caregiver not having internet access
  • Caring for a fee,

Unfollowing Criteria

  • Patient's death
  • Patient and caregiver wanting to quit the study

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual home visit
to evaluate the effectiveness of virtual home visits in terms of time, cost and caregiver competence
Device: Virtual Home Visit
The virtual home visit will be made through the mobile application developed by the researchers. First, the patients who meet the sampling criteria will be included in the study after the caregivers of the patients apply to the Antalya Health Directorate Antalya Training and Research Hospital Home Health Unit. The virtual home visit is scheduled twice
Active Comparator: Home visit
to evaluate the effectiveness of home visits in terms of time, cost and caregiver competence
Device: Control Group
"Face-to-face home visits will be carried out by the Antalya Education and Research Hospital home health team, as planned.
Other Names:
  • Home visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Virtual and Face to face to home visit
Time Frame: Change from baseline effect of visit at 0,3 month
For virtual and face-to-face visits, it includes the type of visit, the health personnel who made the visit, the number of visits, the average visit time (minutes), the duration of the home visit (in terms of time and distance), the materials used in the home visit. It will also be created to calculate the cost effective.
Change from baseline effect of visit at 0,3 month
Frequency of unplanned hospital readmission
Time Frame: Change from baseline effect of virtual visit at 3 month
Unplanned admission to hospital after discharge: The content of the form includes questions about hospital applications after discharge and the reasons for application.
Change from baseline effect of virtual visit at 3 month
Level of competence of stroke caregiver
Time Frame: Change from baseline effect of virtual visit at 0, 3 month (minimum 4 points, maximum 16 points)
Caregiver Competence Scale Caregiver Competence Scale
Change from baseline effect of virtual visit at 0, 3 month (minimum 4 points, maximum 16 points)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the virtual home visit
Time Frame: Change from baseline effect of virtual visit at 3 month (A score ranging from 0-100 is obtained from the scale. A higher score indicates an increased level of usability).
System Usability Scale
Change from baseline effect of virtual visit at 3 month (A score ranging from 0-100 is obtained from the scale. A higher score indicates an increased level of usability).

Collaborators and Investigators

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

Sponsor

The Scientific and Technological Research Council of Turkey

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)

August 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0733

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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