Evaluation of Quality of Life in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic

Covid19 Clinical Trial

Official title:

Evaluation of Quality of Life, Physical Activity and Depression in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558645
• Other study ID #: 91610558-604.01.02
• Status: Completed
• Start date: September 18, 2020
• Est. completion date: December 26, 2020

Study information

• Verified date: December 2020
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

During the COVID-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. For this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and their fear of going out. These reasons have prevented being physically active. The aim of the study is to evaluate the physical activity level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and loneliness perceptions of patients with type 1 diabetes mellitus during the COVID-19 pandemic period and compared with healthy controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 26, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Having been diagnosed with Type 1 Diabetes Mellitus
• Willing to participate in the study
• Participants whose native language is Turkish

Exclusion Criteria:

• Unwilling to participate in the study
• Having a cognitive disorder
• Not being literate
• Individuals who do not have sufficient knowledge and functional levels to fill out the online form

Related Conditions & MeSH terms

• Covid19
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• Online Survey
Online surveys will be applied to all participants

Locations

Country	Name	City	State
Turkey	Zeliha ÇELIK	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity level	Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.	Five minutes
Primary	General Quality of life	Quality of life using Short Form Health Survey (SF-36) will be evaluated.	Ten minutes
Secondary	Depression	Depression using Hospital Anxiety and Depression Scale will be evaluated.	Three minutes
Secondary	Anxiety	Anxiety using Hospital Anxiety and Depression Scale will be evaluated.	Three minutes
Secondary	Self-reported hypoglycemia	It will be questioned how many times patients have had hypoglycemic attacks (<4 mmol/L and common symptoms) in the last 7 days.	Last seven day
Secondary	Loneliness	Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.	Three minutes
Secondary	Hypoglisemia fear	Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.	Five minutes
Secondary	Dyspnea	Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.	Two minutes