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OpenTrials
Completed

NCT Number: NCT04558645

Evaluation of Quality of Life 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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zeliha ÇELİK

Ankara, Çankaya, 06490, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online survey

Other

Online surveys will be applied to all participants

Primary outcomes

  1. Physical activity level

    Time frame: Five minutes

    Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.

  2. General Quality of life

    Time frame: Ten minutes

    Quality of life using Short Form Health Survey (SF-36) will be evaluated.

Secondary outcomes

  1. Depression

    Time frame: Three minutes

    Depression using Hospital Anxiety and Depression Scale will be evaluated.

  2. Anxiety

    Time frame: Three minutes

    Anxiety using Hospital Anxiety and Depression Scale will be evaluated.

  3. Self-reported hypoglycemia

    Time frame: Last seven day

    It will be questioned how many times patients have had hypoglycemic attacks (<4 mmol/L and common symptoms) in the last 7 days.

  4. Loneliness

    Time frame: Three minutes

    Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.

  5. Hypoglisemia fear

    Time frame: Five minutes

    Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.

  6. Dyspnea

    Time frame: Two minutes

    Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 22, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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