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
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
Public
Landesklinikum Melk Krankenhausstraße 11
Melk
3390 Melk
Austria
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 01/02/2018 |
| Completion date | 01/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Total final enrolment | 223 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 01/03/2019 |
Locations
Countries of recruitment
- Austria
Study participating centre
3390
Austria
Sponsor information
Hospital/treatment centre
Krankenhausstraße 11
Melk
3390
Austria
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The 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.
