Clinical trial NCT05197582: The Effect of Telemonitoring on Anxiety and Quality of Life in Patients in COVID 19 Quarantine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pandemic
Keywords: telemedicine
anxiety
quarantine
Quality of Life
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Clinical trial with experimental and control groups with
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

* In the study, a patient whose general condition deteriorated during the COVID 19 quarantine and was hospitalized was excluded from the sample

Primary outcomes:
measure: The MOS 36 Item Short Form Health Survey(SF-36)
timeFrame: 10 days after
Secondary outcomes:
measure: The Beck Anxiety Scale
timeFrame: 10 days after
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Arzu Bahar
Study officials:
affiliation: Yuksek Ihtisas University
name: Arzu Bahar, PhD
role: PRINCIPAL_INVESTIGATOR
References: