COVID-19NCT05258734
The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients
A study testing COVOS app in people with COVID-19 and Symptoms and Signs, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Symptoms and Signs, Quality of Life
- What is being tested?
- COVOS app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jul 2022to 29 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- COVOS app, Standard Care
- Keywords
- Omaha System, Mobile health app
- Medical subject headings
- COVID-19, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVOS appOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COVOS app | Experimental | Not described Receives: Other: COVOS app |
| Control Group | Active comparator | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 1st month, 2nd month and 3rd month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start23 Jul 2022
- Primary completion29 Jul 2022
- Study completion29 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Gizemnur Torun, Kocaeli University
- Investigators
- Selda Seçginli, Prof.Dr., Study director, İstanbul University Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258734
- Sponsor's protocol ID
- 4802180417
- Status last verified
- Nov 2022
- First submitted
- 5 Feb 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05258734
- Acronym / sponsor ID
- 4802180417
- Conditions
- COVID-19, Symptoms and Signs, Quality of Life
- Keywords
- Omaha System, Mobile health app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, The Scientific and Technological Research Council of Turkey
- Study start
- 23 Jul 2022 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Oct 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVOS app | Experimental | Other: COVOS app |
| Control Group | Active comparator | Other: Standard Care |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVOS appIn 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. | Other | COVOS app |
| Standard CareIn 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. | Other | Control Group |
Primary outcome
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Seçginli, Prof.Dr. study director
İstanbul University Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVOS app in people with COVID-19 and Symptoms and Signs, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Symptom Status (time frame: Baseline, 1st month, 2nd month and 3rd month.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.