Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/05/2018
Date assigned
05/06/2018
Last edited
05/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 65 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

Contact information

Type

Public

Primary contact

Dr Nawras Al-taie

ORCID ID

Contact details

Landesklinikum Melk Krankenhausstraße 11
Melk
3390 Melk
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GS1-EK-4/493-2017

Study information

Scientific title

Assessing quality of life in diabetes patients using the WHOQOL- BREF scale and the co-relation to HbA1c

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

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

Participant 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

Sponsor information

Organisation

Landesklinikum Melk

Sponsor details

Krankenhausstraße 11
Melk
3390
Austria

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes