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NCT Number: NCT05258734

The Effect of Mobile Health Application Based on Omaha System on 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Quality of Life RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Symptoms and Signs Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, İzmit, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVOS app

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.

Standard care

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Collaborators

  • Istanbul University - Cerrahpasa
  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2022
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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