The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients

NCT ID: NCT05258734

Last Updated: 2022-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-23

Study Completion Date

2022-10-29

Brief Summary

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Purpose: The aim of this study is to evaluate the effects of nursing interventions made with a mobile health application (COVOS) developed based on the Omaha System on the physical, psychosocial and cognitive symptoms and quality of life of patients diagnosed with COVID-19, and continuing treatment at home.

Design: This is a single center, 1:1 randomized, single blind, parallel, active comparator trial.

Method: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist used in study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. This study will carried out in a family health center, located within the boundaries of İzmit District of Kocaeli province. The patients in the experimental group will be followed up with the COVOS app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the COVOS app. The patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue.

Hypothesis: In patients diagnosed with COVID-19 followed at home with COVOS, symptom management and quality of life will be better in 1st, 2nd and 3rd months compared to the control group.

Detailed Description

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Conditions

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COVID-19 Symptoms and Signs Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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COVOS app

Group Type EXPERIMENTAL

COVOS app

Intervention Type OTHER

In this study, the patients in the experimental group will be followed up with the COVOS app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the COVOS app.

Control Group

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

In this study, the patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue.

Interventions

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COVOS app

In this study, the patients in the experimental group will be followed up with the COVOS app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the COVOS app.

Intervention Type OTHER

Standard Care

In this study, the patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with a positive Polymerase Chain Reaction (PCR) test within the last 24-48 hours
* Patients whose symptoms started within the last 48 hours
* Patients experiencing at least one symptom
* Patients diagnosed with COVID-19 and continuing treatment at home
* Literate patients
* Patients with smartphone

Exclusion Criteria

* Those who have had a previous COVID-19 infection
* Patients with vision or hearing problems
* Patients with chronic disease
* Patients with mental illness
* Patients who do not have a smartphone
* Pregnant and postpartum patients
* Patients who did not agree to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Gizemnur Torun

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selda Seçginli, Prof.Dr.

Role: STUDY_DIRECTOR

İstanbul University Cerrahpasa

Locations

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Kocaeli University

Kocaeli, İzmit, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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4802180417

Identifier Type: -

Identifier Source: org_study_id

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