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

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT04558645
Collaborator
(none)
118
1
3.3
36.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Online Survey

Study Design

Study Type:
Observational
Actual Enrollment :
118 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Quality of Life, Physical Activity and Depression in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic
Actual Study Start Date :
Sep 18, 2020
Actual Primary Completion Date :
Dec 18, 2020
Actual Study Completion Date :
Dec 26, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Physical activity level [Five minutes]

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

  2. General Quality of life [Ten minutes]

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

Secondary Outcome Measures

  1. Depression [Three minutes]

    Depression using Hospital Anxiety and Depression Scale will be evaluated.

  2. Anxiety [Three minutes]

    Anxiety using Hospital Anxiety and Depression Scale will be evaluated.

  3. Self-reported hypoglycemia [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 [Three minutes]

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

  5. Hypoglisemia fear [Five minutes]

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

  6. Dyspnea [Two minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zeliha ÇELİK Ankara Çankaya Turkey 06490

Sponsors and Collaborators

  • Gazi University

Investigators

  • Study Chair: Zeliha ÇELİK, MSc, Gazi University
  • Study Director: Meral BOŞNAK GÜÇLÜ, Prof, Gazi University
  • Principal Investigator: Füsun BALOŞ TÖRÜNER, Prof, Gazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeliha ÇELİK, Research assistant, Gazi University
ClinicalTrials.gov Identifier:
NCT04558645
Other Study ID Numbers:
  • 91610558-604.01.02
First Posted:
Sep 22, 2020
Last Update Posted:
Dec 29, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2020