COVID-19NCT04824469
The Effects of Web-Based Training for Covid-19 Patients on Symptom Management, Medication Compliance and Quality of Life
A study testing intervention group in people with COVID-19, run by Eskisehir Osmangazi University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2021to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Web-Based Training and Telephone Follow-up Developed for Covid-19 Patients on Symptom Management, Medication Compliance and Quality of Life
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/).
Read more
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.
Read the detailed description
G power analysis program was used to determine the sample size. The research will be conducted in two groups, an intervention and a control group. With professional support in calculating the sample size of the study, the sample size calculated at a 5% margin of error and a 95% confidence interval was found to be 128. However, against the possibility of sample losses during the follow-up process, the individual diagnosed with Covid-19 will be added to the number of samples by adding 20% (13 participants will be added for each group. 77 interventions in total, 77 controls) will be included in the study. Participants who meet the inclusion criteria and agree to participate in the study will be randomly assigned to the intervention and control groups.
DATA COLLECTION TOOLS
- Patient information form
- Memorial Symptom Rating Scale
- Covid-19 Symptom Assessment Inventory
- Morisky Adaptation Scale (Muö)
- World Health Organization Quality of Life Inventory Short Form Turkish Version
- E-Health literacy scale
- Opinion Form Regarding the Web Based Training Program
- DISCERN Guide (Expert Opinions)
- Website Content Evaluation Form (Expert Opinions)
- Conditions
- COVID-19
- Being tested
- intervention group
- Keywords
- web based consulting, Medication Compliance, symptom management, covid-19, life quality
- Medical subject headings
- COVID-19, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupOther
web based training: By establishing a website, training on drug use, symptom management and quality of life will be provided.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: first day
Secondary outcomes (3)
Post-intervention measurements
The Covid-19 symptom assessment inventory prepared by scanning the literature will be used to monitor symptoms. The high score obtained from the inventory indicates that the need for disease management continues.
Measured: 1. month
Post-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.
Measured: 1. week
Post-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.
Measured: 1. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Dec 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionDec 2022 (estimated)
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
- Model description
- randomized controlled experimental study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Arslan Özdemir, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824469
- Sponsor's protocol ID
- EkisehirOsmangaziU
- Status last verified
- Nov 2021
- First submitted
- 25 Mar 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Web-Based Training and Telephone Follow-up Developed for Covid-19 Patients on Symptom Management, Medication Compliance and Quality of Life
- ClinicalTrials.gov ID
- NCT04824469
- Acronym / sponsor ID
- EkisehirOsmangaziU
- Conditions
- COVID-19
- Keywords
- web based consulting, Medication Compliance, symptom management, covid-19, life quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Apr 2021 (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.
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.
Detailed description
G power analysis program was used to determine the sample size. The research will be conducted in two groups, an intervention and a control group. With professional support in calculating the sample size of the study, the sample size calculated at a 5% margin of error and a 95% confidence interval was found to be 128. However, against the possibility of sample losses during the follow-up process, the individual diagnosed with Covid-19 will be added to the number of samples by adding 20% (13 participants will be added for each group. 77 interventions in total, 77 controls) will be included in the study. Participants who meet the inclusion criteria and agree to participate in the study will be randomly assigned to the intervention and control groups.
DATA COLLECTION TOOLS
- Patient information form
- Memorial Symptom Rating Scale
- Covid-19 Symptom Assessment Inventory
- Morisky Adaptation Scale (Muö)
- World Health Organization Quality of Life Inventory Short Form Turkish Version
- E-Health literacy scale
- Opinion Form Regarding the Web Based Training Program
- DISCERN Guide (Expert Opinions)
- Website Content Evaluation Form (Expert Opinions)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| web based training | Experimental | Other: intervention group* 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| intervention groupweb based training: By establishing a website, training on drug use, symptom management and quality of life will be provided. | Other | web based training |
Primary outcome
Pre-intervention measurements
Time frame: first day
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.
Pre-intervention measurements
Time frame: first day
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.
Pre-intervention measurements
Time frame: first day
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.
3 secondary outcomes
Post-intervention measurements
Time frame: 1. month
Post-intervention measurements
Time frame: 1. week
Post-intervention measurements
Time frame: 1. month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with COVID-19, run by Eskisehir Osmangazi University.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebru Arslan Özdemir, PhD Student (+90 531 420 96 53, ebruaarslan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-intervention measurements (time frame: first day). The study lists 3 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 10 Nov 2021.