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

November 15, 2022 updated by: Gizemnur Torun, Kocaeli University

The Effect Of Mobile Health Application Based On Omaha System On Physical, Psychosocial, Cognitive Symptoms And Quality Of Life In COVID-19 Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

  • Turkey
    • İzmit
      • Kocaeli, İzmit, Turkey
        • Kocaeli University

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

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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.
Experimental: COVOS app
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Symptom Status
Time Frame: Baseline, 1st month, 2nd month and 3rd month.
Physical symptom status will be assessed using the Omaha System Problem Rating Scale for Outcomes. The Problem Rating Scale for Outcomes is a method to evaluate patient progress throughout the period of service. It consists of three five-point, Likert-type scales to measure the entire range of severity for the concepts of Knowledge, Behavior, and Status.
Baseline, 1st month, 2nd month and 3rd month.
Change in Psychosocial Symptom Status
Time Frame: Baseline, 1st month, 2nd month and 3rd month.

Psychosocial symptom status will be evaluated with Depression Anxiety Stress Scale- 21 (DASS-21). DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. For depression the cutoff scores are: Normal: 0-9, Mild: 10-12, Moderate:13-20, Severe: 21-27, and Extremely severe: 28-42.

For anxiety the cutoff scores are: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe:15-19, and Extremely severe: 20-42. For stress the cutoff scores are: Normal: 0-10, Mild:11-18, Moderate:19-26, Severe: 27-34, and Extremely severe: 35-42.
Baseline, 1st month, 2nd month and 3rd month.
Change in Cognitive Symptom Status
Time Frame: Baseline, 1st month, 2nd month and 3rd month.
Cognitive symptom status will be assessed using the Omaha System Problem Rating Scale for Outcomes. The Problem Rating Scale for Outcomes is a method to evaluate patient progress throughout the period of service. It consists of three five-point, Likert-type scales to measure the entire range of severity for the concepts of Knowledge, Behavior, and Status.
Baseline, 1st month, 2nd month and 3rd month.
Change in Quality of Life
Time Frame: Baseline, 1st month, 2nd month and 3rd month.

Quality of life will be evaluated with the SF-12. The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.

The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. The SF-12 was created to reduce the burden of response.

The SF-12 uses the same eight domains as the SF-36:

Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions
Baseline, 1st month, 2nd month and 3rd month.

Collaborators and Investigators

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

Sponsor

Kocaeli University

Collaborators

The Scientific and Technological Research Council of Turkey
Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: Selda Seçginli, Prof.Dr., Istanbul University Cerrahpasa

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)

July 23, 2022

Primary Completion (Actual)

July 29, 2022

Study Completion (Actual)

October 29, 2022

Study Registration Dates

First Submitted

February 5, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4802180417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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