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

ISRCTN ISRCTN16494373
DOI https://doi.org/10.1186/ISRCTN16494373
Secondary identifying numbers GS1-EK-4/493-2017
Submission date
24/05/2018
Registration date
05/06/2018
Last edited
31/12/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Nawras Al-taie
Public

Landesklinikum Melk Krankenhausstraße 11
Melk
3390 Melk
Austria

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe 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
Study objectivesThis 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(s)Ethics board for the government of Lower Austria region, 21/08/2017, ref: GS1-EK-4/493-2017
Health condition(s) or problem(s) studiedDiabetes mellitus type 1 and type 2
InterventionThe 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 typeOther
Primary outcome measure1. 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 measuresType of diabetes treatment, measured using outpatient data and medical notes at 2 years
Overall study start date01/02/2018
Completion date01/02/2020

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants250
Total final enrolment223
Key inclusion criteriaCurrent 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
Key exclusion criteriaCurrent 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
Date of first enrolment01/03/2018
Date of final enrolment01/03/2019

Locations

Countries of recruitment

  • Austria

Study participating centre

Melk General Hospital
Melk
3390
Austria

Sponsor information

Landesklinikum Melk
Hospital/treatment centre

Krankenhausstraße 11
Melk
3390
Austria

Funders

Funder type

Hospital/treatment centre

Melk General Hospital

No information available

Results and Publications

Intention to publish date01/02/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned 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 planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nawras Al-Taie.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/12/2019 31/12/2019 Yes No
Results article results 01/09/2011 31/12/2019 Yes No

Editorial Notes

31/12/2019: Publication references added.
05/04/2019: Internal review.
04/04/2019: The total final enrollment was added.
17/10/2018: The title was updated from "Assessing quality of life in diabetes patients using the WHOQOL- BREF scale and the co-relation to HbA1c" to "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".
24/08/2018: The inclusion and exclusion criteria were updated.