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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Comprehension of health education leaflets designed for patients with limited literacy – a randomized controlled trial
Scientific title
In adults with diabetes, is a simplified layout leaflet more effective than a standard trifold brochure in knowledge comprehension at 1 month?
Secondary ID [1] 280863 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient education 286933 0
Diabetes 286934 0
Condition category
Condition code
Diet and Nutrition 287264 287264 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 287265 287265 0 0
Public Health 287266 287266 0 0
Health promotion/education

Study type
Description of intervention(s) / exposure
A simplified format health education leaflet printed on A5 paper, one side only.
The leaflet contains 8 information items related to diabetes including diet (e.g., fruit juice can raise blood sugar level) and exercise (e.g., exercise can lower blood sugar level). Each item is presented as a bullet point with a relevant color photograph.

The leaflet shall be handed to the patient and discussed briefly (5 - 20 min) by the clinic nurse after baseline assessment (demographic and vital signs).
Intervention code [1] 285292 0
Comparator / control treatment
A standard A4 trifold health education brochure on diabetes with all the 8 items from the Intervention leaflet as well as additional information on diabetes. This leaflet also includes photographs. The amount and density of information as well as reading difficulty is higher.

The leaflet shall be handed to the patient and discussed briefly (5 - 20 min) by the clinic nurse after baseline assessment (demographic and vital signs).
Control group

Primary outcome [1] 287543 0
Comprehension score on the translated and modified Michigan Diabetes Knowledge Test.
Timepoint [1] 287543 0
1 month after enrollment.
Secondary outcome [1] 298359 0
Subgroup analyses of items on the Diabetes Knowledge Test with respect to subject characteristics (age, gender, health literacy, recent HbA1c, recent blood pressure, recent cholesterol level, number of visits in the last 1 year, number of HbA1c measurements in the last one year).

Health literacy will be assessed by the questions:
9. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from you doctor or pharmacist?
10. How confident are you filling out medical forms by yourself?
Timepoint [1] 298359 0
1 month after enrollment.

Key inclusion criteria
1. Adults: age more than 18 years
2. Clinical diagnosis of diabetes mellitus type 2 or 1.
Minimum age
18 Years
Maximum age
100 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Pregnancy
2. Severe co-morbid medical conditions such as heart failure, organ transplant
3. Apparent visual, hearing or mental impairment

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients meeting inclusion criteria will be requested to participate in the study by the clinic nurse. If the patient declines to participate, the reason (if any) will be recorded in the Refusals Register.

1. Informed Consent form will be signed by the patient.
2. Randomization. The Nurse will open the next serially numbered randomization envelope and record the allocation to A or B on the Random Allocation Register.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 4412 0
United Arab Emirates
State/province [1] 4412 0
Abu Dhabi

Funding & Sponsors
Funding source category [1] 285647 0
Name [1] 285647 0
Emirates Foundation
Address [1] 285647 0
PO Box 111445
Mezzanine Floor, Al Mamoura Building
4th & 15th Streets
Abu Dhabi
Country [1] 285647 0
United Arab Emirates
Primary sponsor type
UAE University
College of Medicine and Health Sciences
PO Box 17666
Al Ain
United Arab Emirates
Secondary sponsor category [1] 284482 0
Name [1] 284482 0
Address [1] 284482 0
Country [1] 284482 0

Ethics approval
Ethics application status
Ethics committee name [1] 287645 0
Al Ain Medical District Human Research Ethics Committee
Ethics committee address [1] 287645 0
Dr Satish Chandra Nair
Tawam Hospital
PO Box 15258
Al Ain
Ethics committee country [1] 287645 0
United Arab Emirates
Date submitted for ethics approval [1] 287645 0
Approval date [1] 287645 0
Ethics approval number [1] 287645 0

Brief summary
Adults with diabetes will be divided into two groups: one group shall receive a printed leaflet about diabetes specially designed for persons with limited reading skills. The other group will receive a standard printed leaflet on diabetes. The effect on understanding will tested in both groups by a telephone interview after one month.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34449 0
Address 34449 0
Country 34449 0
Phone 34449 0
Fax 34449 0
Email 34449 0
Contact person for public queries
Name 17696 0
Dr M Jawad Hashim
Address 17696 0
Department of Family Medicine
College of Medicine and Health Sciences
PO Box 17666
Al Ain
Country 17696 0
United Arab Emirates
Phone 17696 0
+971 3 7137 409
Fax 17696 0
+971 3 767 2022
Email 17696 0
Contact person for scientific queries
Name 8624 0
Dr M Jawad Hashim
Address 8624 0
Department of Family Medicine
College of Medicine and Health Sciences
PO Box 17666
Al Ain
Country 8624 0
United Arab Emirates
Phone 8624 0
+971 3 7137 409
Fax 8624 0
+971 3 767 2022
Email 8624 0

No information has been provided regarding IPD availability
Summary results
No Results