NCT06362135

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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 Start

First participant enrolled

August 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

April 8, 2024

Last Update Submit

April 11, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Effect of Virtual and Face to face to home visit

    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

  • Level of competence of stroke caregiver

    Caregiver Competence Scale Caregiver Competence Scale

    Change from baseline effect of virtual visit at 0, 3 month (minimum 4 points, maximum 16 points)

  • Frequency of unplanned hospital readmission

    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

Secondary Outcomes (1)

  • Effect of the virtual home visit

    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).

Study Arms (2)

Virtual home visit

EXPERIMENTAL

to evaluate the effectiveness of virtual home visits in terms of time, cost and caregiver competence

Device: Virtual Home Visit

Home visit

ACTIVE COMPARATOR

to evaluate the effectiveness of home visits in terms of time, cost and caregiver competence

Device: Control Group

Interventions

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

Virtual home visit

"Face-to-face home visits will be carried out by the Antalya Education and Research Hospital home health team, as planned.

Also known as: Home visit
Home visit

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin Demi̇r Avci̇

Antalya, 07058, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Yasemin Demir Avcı, PHD

CONTACT

Neşe Zayim, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Telephone support or virtual meeting during the research process will be provided by an independent interviewer.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Parallel Assignment Virtual visit with stroke patient and their caregiver
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. (Assistant professor)

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 12, 2024

Study Start

August 1, 2023

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

April 15, 2024

Record last verified: 2024-04

Locations