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Trial registered on ANZCTR


Registration number
ACTRN12612000761864
Ethics application status
Approved
Date submitted
17/07/2012
Date registered
18/07/2012
Date last updated
18/07/2012
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
Nil
Universal Trial Number (UTN)
U1111-1132-7230
Trial acronym
EF217
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
Diabetes
Public Health 287266 287266 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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
Lifestyle
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
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
Charities/Societies/Foundations
Name [1] 285647 0
Emirates Foundation
Country [1] 285647 0
United Arab Emirates
Primary sponsor type
University
Name
UAE University
Address
College of Medicine and Health Sciences
PO Box 17666
Al Ain
Country
United Arab Emirates
Secondary sponsor category [1] 284482 0
None
Name [1] 284482 0
Address [1] 284482 0
Country [1] 284482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287645 0
Al Ain Medical District Human Research Ethics Committee
Ethics committee address [1] 287645 0
Ethics committee country [1] 287645 0
United Arab Emirates
Date submitted for ethics approval [1] 287645 0
Approval date [1] 287645 0
10/02/2010
Ethics approval number [1] 287645 0
09/38

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
jhashim@uaeu.ac.ae
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
jhashim@uaeu.ac.ae

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.