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

NCT05258734 | Completed

• 1 other identifier: 4802180417
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Symptoms and Signs; Quality of Life

Keywords

Omaha System; Mobile health app

Outcome Measures

Primary Outcomes (4)

• Change in Physical Symptom Status

  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

  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

  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

  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.

Study Arms (2)

COVOS app

EXPERIMENTAL

Other: COVOS app

Control Group

ACTIVE COMPARATOR

Other: Standard Care

Interventions

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.

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead
• Istanbul University - Cerrahpasa: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Kocaeli University

Kocaeli, İzmit, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Signs and Symptoms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Selda Seçginli, Prof.Dr.

  İstanbul University Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 28, 2022
• Study Start: July 23, 2022
• Primary Completion: July 29, 2022
• Study Completion: October 29, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)