The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients
Primary Purpose
COVID-19, Symptoms and Signs, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
COVOS app
Standard Care
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19 focused on measuring Omaha System, Mobile health app
Eligibility Criteria
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
Sites / Locations
- Kocaeli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
COVOS app
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05258734
First Posted
February 5, 2022
Last Updated
November 15, 2022
Sponsor
Kirsehir Ahi Evran University
Collaborators
Istanbul University - Cerrahpasa (IUC), The Scientific and Technological Research Council of Turkey
1. Study Identification
Unique Protocol Identification Number
NCT05258734
Brief Title
The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients
Official Title
The Effect Of Mobile Health Application Based On Omaha System On Physical, Psychosocial, Cognitive Symptoms And Quality Of Life In COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 23, 2022 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
October 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
Collaborators
Istanbul University - Cerrahpasa (IUC), The Scientific and Technological Research Council of Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Symptoms and Signs, Quality of Life
Keywords
Omaha System, Mobile health app
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVOS app
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
COVOS app
Intervention Description
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
Intervention Name(s)
Standard Care
Intervention Description
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 Outcome Measure Information:
Title
Change in Physical Symptom Status
Description
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.
Time Frame
Baseline, 1st month, 2nd month and 3rd month.
Title
Change in Psychosocial Symptom Status
Description
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.
Time Frame
Baseline, 1st month, 2nd month and 3rd month.
Title
Change in Cognitive Symptom Status
Description
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.
Time Frame
Baseline, 1st month, 2nd month and 3rd month.
Title
Change in Quality of Life
Description
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
Time Frame
Baseline, 1st month, 2nd month and 3rd month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda Seçginli, Prof.Dr.
Organizational Affiliation
İstanbul University Cerrahpasa
Official's Role
Study Director
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
State/Province
İzmit
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients
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