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

NCT04558645 | Completed

• 1 other identifier: 91610558-604.01.02
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus; Covid19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Depression

  Three minutes

• Anxiety

  Three minutes

• Self-reported hypoglycemia

  Last seven day

• Loneliness

  Three minutes

• Hypoglisemia fear

  Five minutes

Study Arms (2)

Patients with type 1 diabetes mellitus

Patients with Type 1 diabetes mellitus willing to participate in the study

Other: Online Survey

Healthy controls

Healthy controls without chronic disease willing to participate in the study

Other: Online Survey

Interventions

Online Survey OTHER

Online surveys will be applied to all participants

Healthy controls; Patients with type 1 diabetes mellitus

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Zeliha ÇELİK

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; COVID-19

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zeliha ÇELİK, MSc

  Gazi University

  STUDY CHAIR

• Meral BOŞNAK GÜÇLÜ, Prof

  Gazi University

  STUDY DIRECTOR

• Füsun BALOŞ TÖRÜNER, Prof

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 22, 2020
• Study Start: September 18, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 26, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

TU (1)