COVID-19 PandemicNCT05197582
The Effect of Telemonitoring on Anxiety and Quality of Life in Patients in COVID 19 Quarantine
A study testing tele-monitoring in people with COVID-19 Pandemic, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial summary
The study was carried out to evaluate the effect of telemonitoring service to be given to patients kept under quarantine during the COVID 19 pandemic on anxiety and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- tele-monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Sep 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer patients who were diagnosed with COVID 19, over the age of 18, had no communication problems, were literate, had no diagnosed mental pathology, were able to use smartphones were included in the study
Who cannot join
- In the study, a patient whose general condition deteriorated during the COVID 19 quarantine and was hospitalized was excluded from the sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Tele-Health Application on Anxiety Level and Quality of Life of Patients in COVID-19 Quarantine: A Quasi-experimental Study
The study was carried out to evaluate the effect of telemonitoring service to be given to patients kept under quarantine during the COVID 19 pandemic on anxiety and quality of life.
Read the detailed description
The COVID 19 pandemic, which continues today, has caused radical changes in social, cultural, education, and health systems around the world(Zhang and Liu 2020; Wang et all 2020; Alipour \&Abdolahzadeh 2020). In this period, health care providers tried to use telehealth services as a good alternative to solve the problems caused by quarantine, social isolation practices to reduce the rate of transmission of the disease, and the limitation of physical access to health services due to the risk of transmission.
Thus, the use of telehealth applications, which first started in the 1950s, gained momentum especially during the pandemic period (Byrne 2020; Lurie \& Carr 2018; Clipper 2020; Fagherazzi 2020). Telehealth applications, which have the opportunity to be widely used during the COVID 19 pandemic period, are generally a system that provides two-way communication between healthcare professionals and patients and includes image, speech, and digital communication technologies (Hazin \& Qaddoumi, 2010; Merz et all 2021; Bryne 2020). Tele-monitoring is a good option to support patients in the management of existing physical symptoms of quarantined patients who are isolated at home, except for patients who need outpatient or hospital treatment in the COVID 19 pandemic. In studies investigating the presence of mental problems as a result of the decrease in the social support of the patients in this group due to social isolation, the study results indicate that the patients experience negative conditions such as depression, stress, sleep problems, and anxiety (Verma 2020, Alipour et all 2020; Chakeri et all 2020).
Therefore, when quarantined patients are evaluated holistically, there is a need for studies evaluating the effect of telehealth services to increase the quality of life by coping with mental problems such as anxiety and depression. Although there are studies in the related literature showing that telemonitoring can cope with physical problems, improve quality of life, and reduce mental problems such as anxiety and depression, studies showing the effect of telemonitoring given to quarantined patients on anxiety and quality of life are quite limited (Kamei et all 2021; Jahromi et all 2016; Charekei et all 2020; Allipour et all 2020). For this reason, our study was carried out to evaluate the effect of telemonitoring service to be given to patients kept under quarantine during the COVID 19 pandemic on anxiety and quality of life.
- Conditions
- COVID-19 Pandemic
- Being tested
- tele-monitoring
- Keywords
- telemedicine, anxiety, quarantine, Quality of Life
- Medical subject headings
- COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele-monitoringOther
The symptoms of the patients were evaluated by calling the patients on the 1st, 5th, and 9th days of the quarantine by the researchers.
| Study group | Role | What they receive |
|---|---|---|
| Tele-monitoring group | Active comparator | The researchers called the patients in the experimental group on the first day of the quarantine and explained the topics covered in the COVID 19 patient education booklet to the patients. Patient education and follow-up in quarantine took approximately 25-30 minutes for each patient in the experimental group. The patients in quarantine were followed up by the researchers two more times, on the 5th and 9th days of the quarantine. On the 10th and last day of the quarantine, post-test online questionnaires were sent to the patients for the second time, and the data collection phase was ended. Receives: Other: tele-monitoring |
| Plasebo group | No intervention | The patients in the control group were called by the researchers on the first day of the quarantine and asked to fill in the online pre-test forms. On the 10th day, the last day of the quarantine, the patients were called and the online post-test forms were sent for the second time, and the data were collected. There was no telephone follow up in the control group and the patients received only routine care in the home |
What is being measured
The primary outcome is the main question the study is designed to answer.
The MOS 36 Item Short Form Health Survey(SF-36)
Scores of SF 36-Quality of Life Scale The scale consists of 8 subscales, including physical function, social function, physical role function, emotional role function, mental health, vitality, pain, and general health, and a total of 36 items. Evaluation in the scale is Likert type except for some items and the last 4 weeks are taken into consideration. Subscales evaluate health between 0-100 and the higher the score, the better the quality of life.
Measured: 10 days after
Secondary outcomes (1)
The Beck Anxiety Scale
The scores of the Beck Anxiety Scale It is a Likert-type assessment tool in which scores ranging from 0 to 3 are given in the 21-item scale. 8-15 points obtained from the scale = Mild anxiety, 16-25 points = Moderate anxiety, 26-63 points = Severe anxiety. While the lowest score that can be taken from the scale is 0, the highest score that can be obtained from the scale is 63. A high total score indicates an increase in anxiety severity
Measured: 10 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A Clinical trial with experimental and control groups with
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Bahar, Yuksek Ihtisas University
- Investigators
- Arzu Bahar, PhD, Principal investigator, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197582
- Sponsor's protocol ID
- YuksekIU-ABAHAR-001
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tele-Health Application on Anxiety Level and Quality of Life of Patients in COVID-19 Quarantine: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT05197582
- Acronym / sponsor ID
- YuksekIU-ABAHAR-001
- Conditions
- COVID-19 Pandemic
- Keywords
- telemedicine, anxiety, quarantine, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 19 Jan 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.
The study was carried out to evaluate the effect of telemonitoring service to be given to patients kept under quarantine during the COVID 19 pandemic on anxiety and quality of life.
Detailed description
The COVID 19 pandemic, which continues today, has caused radical changes in social, cultural, education, and health systems around the world(Zhang and Liu 2020; Wang et all 2020; Alipour \&Abdolahzadeh 2020). In this period, health care providers tried to use telehealth services as a good alternative to solve the problems caused by quarantine, social isolation practices to reduce the rate of transmission of the disease, and the limitation of physical access to health services due to the risk of transmission.
Thus, the use of telehealth applications, which first started in the 1950s, gained momentum especially during the pandemic period (Byrne 2020; Lurie \& Carr 2018; Clipper 2020; Fagherazzi 2020). Telehealth applications, which have the opportunity to be widely used during the COVID 19 pandemic period, are generally a system that provides two-way communication between healthcare professionals and patients and includes image, speech, and digital communication technologies (Hazin \& Qaddoumi, 2010; Merz et all 2021; Bryne 2020). Tele-monitoring is a good option to support patients in the management of existing physical symptoms of quarantined patients who are isolated at home, except for patients who need outpatient or hospital treatment in the COVID 19 pandemic. In studies investigating the presence of mental problems as a result of the decrease in the social support of the patients in this group due to social isolation, the study results indicate that the patients experience negative conditions such as depression, stress, sleep problems, and anxiety (Verma 2020, Alipour et all 2020; Chakeri et all 2020).
Therefore, when quarantined patients are evaluated holistically, there is a need for studies evaluating the effect of telehealth services to increase the quality of life by coping with mental problems such as anxiety and depression. Although there are studies in the related literature showing that telemonitoring can cope with physical problems, improve quality of life, and reduce mental problems such as anxiety and depression, studies showing the effect of telemonitoring given to quarantined patients on anxiety and quality of life are quite limited (Kamei et all 2021; Jahromi et all 2016; Charekei et all 2020; Allipour et all 2020). For this reason, our study was carried out to evaluate the effect of telemonitoring service to be given to patients kept under quarantine during the COVID 19 pandemic on anxiety and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Clinical trial with experimental and control groups with
| Arm | Type | Receives |
|---|---|---|
| Tele-monitoring group | Active comparator | Other: tele-monitoringThe researchers called the patients in the experimental group on the first day of the quarantine and explained the topics covered in the COVID 19 patient education booklet to the patients. Patient education and follow-up in quarantine took approximately 25-30 minutes for each patient in the experimental group. The patients in quarantine were followed up by the researchers two more times, on the 5th and 9th days of the quarantine. On the 10th and last day of the quarantine, post-test online questionnaires were sent to the patients for the second time, and the data collection phase was ended. |
| Plasebo group | No intervention | –The patients in the control group were called by the researchers on the first day of the quarantine and asked to fill in the online pre-test forms. On the 10th day, the last day of the quarantine, the patients were called and the online post-test forms were sent for the second time, and the data were collected. There was no telephone follow up in the control group and the patients received only routine care in the home |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteer patients who were diagnosed with COVID 19, over the age of 18, had no communication problems, were literate, had no diagnosed mental pathology, were able to use smartphones were included in the study
Key exclusion criteria (1 listed)
- In the study, a patient whose general condition deteriorated during the COVID 19 quarantine and was hospitalized was excluded from the sample
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 |
|---|---|---|
| tele-monitoringThe symptoms of the patients were evaluated by calling the patients on the 1st, 5th, and 9th days of the quarantine by the researchers. | Other | Tele-monitoring group |
Primary outcome
The MOS 36 Item Short Form Health Survey(SF-36)
Time frame: 10 days after
Scores of SF 36-Quality of Life Scale The scale consists of 8 subscales, including physical function, social function, physical role function, emotional role function, mental health, vitality, pain, and general health, and a total of 36 items. Evaluation in the scale is Likert type except for some items and the last 4 weeks are taken into consideration. Subscales evaluate health between 0-100 and the higher the score, the better the quality of life.
1 secondary outcome
The Beck Anxiety Scale
Time frame: 10 days after
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 19 Jan 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.
Arzu Bahar, PhD principal investigator
Yuksek Ihtisas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-monitoring in people with COVID-19 Pandemic, run by Yuksek Ihtisas 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 1 inclusion and 1 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 19 Jan 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?
The MOS 36 Item Short Form Health Survey(SF-36) (time frame: 10 days after). 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 19 Jan 2022.