The Effect of Telemonitoring on Anxiety and Quality of Life in Patients in COVID 19 Quarantine

NCT05197582 | Completed

• 1 other identifier: YuksekIU-ABAHAR-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic

Keywords

telemedicine; anxiety; quarantine; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  10 days after

Secondary Outcomes (1)

• The Beck Anxiety Scale

  10 days after

Study Arms (2)

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.

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

Interventions

tele-monitoring OTHER

The symptoms of the patients were evaluated by calling the patients on the 1st, 5th, and 9th days of the quarantine by the researchers.

Tele-monitoring group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Study Sites (1)

Arzu Bahar

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

Study Officials

• Arzu Bahar, PhD

  Yuksek Ihtisas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: A Clinical trial with experimental and control groups with

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 19, 2022
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)