Clinical trial NCT05258734: 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
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Symptoms and Signs
Quality of Life
Keywords: Omaha System
Mobile health app
Lead sponsor: Kocaeli University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: The Scientific and Technological Research Council of Turkey
First posted: 2022-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Physical Symptom Status
timeFrame: Baseline, 1st month, 2nd month and 3rd month.
measure: Change in Psychosocial Symptom Status
timeFrame: Baseline, 1st month, 2nd month and 3rd month.
measure: Change in Cognitive Symptom Status
timeFrame: Baseline, 1st month, 2nd month and 3rd month.
measure: Change in Quality of Life
timeFrame: Baseline, 1st month, 2nd month and 3rd month.
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
state: İzmit
Study officials:
affiliation: İstanbul University Cerrahpasa
name: Selda Seçginli, Prof.Dr.
role: STUDY_DIRECTOR
References: