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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Online Survey

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06490
      • Zeliha ÇELİK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 diabetes mellitus and healthy controls between 18-65 years

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with type 1 diabetes mellitus; Patients with Type 1 diabetes mellitus willing to participate in the study	Other: Online Survey; Online surveys will be applied to all participants
Healthy controls; Healthy controls without chronic disease willing to participate in the study	Other: Online Survey; Online surveys will be applied to all participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.	Five minutes
General Quality of life	Quality of life using Short Form Health Survey (SF-36) will be evaluated.	Ten minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Depression using Hospital Anxiety and Depression Scale will be evaluated.	Three minutes
Anxiety	Anxiety using Hospital Anxiety and Depression Scale will be evaluated.	Three minutes
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
Loneliness	Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.	Three minutes
Hypoglisemia fear	Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.	Five minutes
Dyspnea	Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.	Two minutes

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: Meral BOŞNAK GÜÇLÜ, Prof, Gazi University; Study Chair: Zeliha Çelik, MsC, Gazi University; Principal Investigator: Füsun BALOŞ TÖRÜNER, Prof, Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 26, 2020

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 26, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 91610558-604.01.02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No