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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	21 January 2020
Main ID:	ISRCTN16494373
Date of registration:	05/06/2018
Prospective Registration:	No
Primary sponsor:	Landesklinikum Melk
Public 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
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
Date of first enrolment:	01/03/2018
Target sample size:	250
Recruitment status:	Ongoing
URL:	http://isrctn.com/ISRCTN16494373
Study type:	Observational
Study design:	Observational cross-sectional study (Quality of life)
Phase:	Not Applicable

Countries of recruitment
Austria

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Nawras Al-taie
Address:	Landesklinikum Melk Krankenhausstraße 11 3390 Melk Melk Austria
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes mellitus type 1 and type 2
Nutritional, Metabolic, Endocrine
Diabetes mellitus

Intervention(s)

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).

Primary Outcome(s)

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(s)

Type of diabetes treatment, measured using outpatient data and medical notes at 2 years

Secondary ID(s)

GS1-EK-4/493-2017

Source(s) of Monetary Support

Melk General Hospital

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics board for the government of Lower Austria region, 21/08/2017, ref: GS1-EK-4/493-2017

Results

Results available:	Yes
Date Posted:
Date Completed:	01/02/2020
URL:

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