NCT04824469

Brief Summary

2019 coronavirus disease (Covid-19) is a virus that emerged in Wuhan, China in late 2019, spread all over the world in a short time and causes severe acute respiratory syndrome and pneumonia. The World Health Organization classified the COVID-19 outbreak as an "international public health emergency" on January 30 and declared a global epidemic (pandemic) on March 11, 2020, due to the rapid spread of the virus all over the world. speed in the number of cases and deaths. Covidien-19 first cases were reported in Turkey on 10 March 2020 and the number of cases has risen steadily. The total number of COVID-19 cases worldwide on 31.01.2021; It was reported to be 101,917,147 and the total number of deaths was 2,205,515 (https://covid19.who.int/). Considering that the number of cases is constantly increasing, it is obvious that hospitals will not meet the entire epidemic burden. During this period, home care has emerged as an alternative way to effectively alleviate the epidemic burden. Home healthcare during the COVID-19 pandemic; Four roles have stood out: home diagnosis, follow-up, treatment, and care. Protective measures for home isolation of Covid-19 patients are the current method used to prevent the spread of cases. Possible or definite cases that do not have an indication for hospitalization, have a mild clinic and do not accompany severe chronic disease that may lead to a severe course of covid-19 are followed at home until their symptoms improve. In addition, patients who are hospitalized and meet discharge criteria can complete their recovery processes at home. Isolation is terminated on the 14th day at the earliest following the improvement of symptoms in patients who are followed at home. Reducing the contact of people, isolating certain and suspicious cases and effective use of personal protective equipment play an important role in combating the epidemic. It is thought that the training that COVID-19 cases to be followed up and treated at home will be effective in drug compliance, symptom management and quality of life will be effective in the management of the disease. 1251 / 5000 Çeviri sonuçları The universe of the research will be composed of people who apply to Zonguldak Atatürk State Hospital Emergency Service and Covid-19 Polyclinics. . The sample of the study, who accepted to participate in the study, was diagnosed with Covid-19 with U07.3 ICD code according to the results of PCR (Polymerase Chain Reaction) test and Thorax CT (Thorax CT), and was recommended to be followed up and treated at home by the Zonguldak Public Health Department It is planned to create individuals who meet the criteria.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable covid19

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

March 25, 2021

Last Update Submit

November 9, 2021

Conditions

Keywords

web based consultingMedication Compliancesymptom managementcovid-19life quality

Outcome Measures

Primary Outcomes (3)

  • Pre-intervention measurements

    The Covid-19 symptom assessment inventory prepared by scanning the literature will be used to monitor the symptoms. The high score obtained from the inventory indicates the need for disease management.

    first day

  • Pre-intervention measurements

    Morisky drug compliance scale to measure drug compliance: is a self-report scale consisting of four questions. The questions are answered as "yes (1 point) and no (0 point). Increasing the score obtained from the scale indicates that drug compliance is low.

    first day

  • Pre-intervention measurements

    The Turkish version of the World Health Organization Quality of Life Inventory Short Form will be used to measure the quality of life. The scale is a Likert type form consisting of 27 questions. Higher total scores obtained from the scale indicate a good quality of life.

    first day

Secondary Outcomes (3)

  • Post-intervention measurements

    1. month

  • Post-intervention measurements

    1. week

  • Post-intervention measurements

    1. month

Study Arms (2)

web based training

EXPERIMENTAL

* Patients on the first day; Patient Information Form (1st and 2nd part), Memorial Symptom Assessment Scale, Covid-19 Symptom Assessment Inventory, Morisky Compliance Scale, World Health Organization Quality of Life Scale Short Form Turkish Version, E-Health literacy scale on website or mobile devices Google via the form or by sending a phone link. * Morisky Compliance Scale will be applied on the 7th day by sending a link to the website or mobile devices via google form. * Patients in the intervention group will be asked to fill out the Covid-19 Symptom Assessment Inventory on the website when they experience changes in their symptoms. * Patients in the intervention group will be provided with web-based training and telephone (SMS) reminder service for 4 weeks. * All questionnaires and web site evaluation form will be filled in the pre-test after 4 weeks.

Other: intervention group

standard care

NO INTERVENTION

The scales applied to the intervention group on the first day, by sending the E-Health literacy scale form or phone link via Google on mobile devices. The symptoms of the patients in the control group will be evaluated at the end of the 1st day, 7th day, 14th day and 4th day. No intervention was planned for the patients in the control group during the follow-up. In the standard practice protocol, after patients are informed for follow-up and treatment at home, they are called by the Ministry of Health and family physicians for symptom follow-up. The standard hospital protocol does not include a scheduled training program, telephone monitoring, or web-based training. After collecting the data in the intervention group, the website will be opened to the use of the control group.

Interventions

web based training: By establishing a website, training on drug use, symptom management and quality of life will be provided.

web based training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 18,
  • Does not have a communication problem that prevents participation in research or education, such as inability to understand / speak Turkish,
  • Being literate,
  • Residing in Zonguldak province, applying to hospitals in the province and diagnosed with Covid-19 according to PCR (Polymerase Chain Reaction) test and Thorax CT (Thorax computed tomography) results by the radiation teams and deemed appropriate for home follow-up by the Zonguldak Public Health Directorate,
  • Having active Internet access and actively using a computer / tablet or smartphone,
  • Patients who agree to participate in the study

You may not qualify if:

  • No internet connection at home or on the phone,
  • Do not know how to use internet and computers,
  • Having a communication problem that prevents participation in research or education, such as inability to understand / speak Turkish, Patients who were previously diagnosed with Covid-19 and treated at home or in hospital,
  • With severe insufficiency (Heart failure, Kidney failure, Immune system failure)
  • Illiterate individuals will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19Medication Adherence

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Ebru Arslan Özdemir, PhD Student

CONTACT

Özlem Örsal, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 1, 2021

Study Start

December 15, 2021

Primary Completion

May 1, 2022

Study Completion

December 1, 2022

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share