Plain English Summary
Background and study aims
Patients with diabetes have a lower quality of life compared with individuals without diabetes in the same age group, and the quality of life in diabetes patients continues to deteriorate with disease progression and complications. Diabetes imposes a considerable economic burden on the society as a whole, and on individual patients and their families. Reduced quality of life in diabetes patients through disability, diabetes complications and loss of productivity may negatively influence economic progress. Better quality of life may also improve adherence to diabetes therapy and also may lead to better glucose control and fewer complications. This study will examine the correlation between glucose control and the WHOQOL-BREF quality of life score and also the relationship between the quality of life score and the Hba1C value.
Who can participate?
Patients aged 18 to 80 with diabetes type 1 or type 2
What does the study involve?
Quality of life is evaluated using the WHOQOL-BREF questionnaire form. Glucose control is measured using HbA1c value in the medical notes and yype of diabetes treatment is measured using outpatient data and medical notes.
What are the possible benefits and risks of participating?
The aim of this study is to measure and improve quality of life for diabetes patients in the diabetes outpatient clinic. It is a survey using a questionnaire and there will be no risks for the participants.
Where is the study run from?
Melk General Hospital (Austria)
When is the study starting and how long is it expected to run for?
February 2018 to February 2020
Who is funding the study?
Melk General Hospital (Austria)
Who is the main contact?
Dr Nawras Altaie
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GS1-EK-4/493-2017
Study information
Scientific title
The correlation between the quality of life using the World Health Organization Quality of Life Assessment questionnaire (WHOQOL- BREF) and Glycated Haemoglobin (HbA1c) in patients with diabetes
Acronym
Study hypothesis
This study will examine the correlation between glycemic control and WHOQOL-BREF scale score and also the relationship between the quality of life score and the HbA1C value. This study will examine the internal consistency, responsiveness and the reliability of the WHOQOL-BREF scale and its four domains (Physical health, Physical health, Social relationships and Environment) for patients living with diabetes in Austria.
Ethics approval
Ethics board for the government of Lower Austria region, 21/08/2017, ref: GS1-EK-4/493-2017
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Diabetes mellitus type 1 and type 2
Intervention
The data is collected over 6-12 months. Quality of life is assessed using the WHOQOL-BREF questionnaire.
The latest HbA1c is documented for each patient in their WHOQOL-BREF questionnaire form. Patients will be further subdivided into different groups according to their diabetes therapy (the patient should be on this therapy for at least 6 months).
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Quality of life, measured using the German version of WHO-BREF at 2 years
2. Glycemic control, measured using HbA1c value in the medical notes at 2 years
Secondary outcome measures
Type of diabetes treatment, measured using outpatient data and medical notes at 2 years
Overall trial start date
01/02/2018
Overall trial end date
01/02/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 24/08/2018:
1. Patients with diabetes both type 1 and type 2
2. Age range between 18 and 80 years old
Previous exclusion criteria:
1. Patients with diabetes both type 1 and type 2
2. Age range between 18 and 65 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Total final enrolment
223
Participant exclusion criteria
Current exclusion criteria as of 24/08/2018:
1. Gestational diabetes
2. Patients younger than 18 and older than 80
Previous exclusion criteria:
1. Gestational diabetes
2. Patients younger than 18 and older than 65
Recruitment start date
01/03/2018
Recruitment end date
01/03/2019
Locations
Countries of recruitment
Austria
Trial participating centre
Melk General Hospital
Melk
3390
Austria
Funders
Funder type
Hospital/treatment centre
Funder name
Melk General Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned to be published in a peer-reviewed journal related to diabetes and with a high impact factor. The trialists also plan to present this study at national and international meetings to increase awareness about quality of life in diabetic patients.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nawras Al-Taie.
Intention to publish date
01/02/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in https://www.doi.org/10.1016/j.pcd.2019.11.003 (added 31/12/2019)
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/21191622 (added 31/12/2019)