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Trial registered on ANZCTR


Registration number
ACTRN12611000836932
Ethics application status
Approved
Date submitted
8/08/2011
Date registered
9/08/2011
Date last updated
9/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a colour coded HbA1c-recording graph in improving diabetes control in people with type 2 diabetes: A randomized control trial.
Scientific title
The effectiveness of colour coded HbA1c recording graph in improving diabetes control as compare to HbA1c recording table in patient with type 2 diabetes: A randomized control trial.
Secondary ID [1] 262795 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes mellitus control 270501 0
education about the diabetes control 270502 0
Condition category
Condition code
Metabolic and Endocrine 270662 270662 0 0
Diabetes
Public Health 270671 270671 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A graph measured 12 x 13cm with 7 points on the y- axis and 6 points on the x- axis was printed on a ivory white card measured 21cmx24cm. The graph was divided horizontally into green, yellow, red and black area, represented good, can be improved, high and too high HbA1c level respectively. The card was covered with a blue colour paper printed with title “HbA1c Card” and the researcher name plus the phone number.

The HbA1c result was plotted on the graph at the corresponding follow up duration (x-axis) and trend were exhibited by drawing a line between the results.

The patient in the HbA1c recording graph group will received the card at the recruitment day. They will keep the card and bring it during the follow up day. The researcher will update the HbA1c reading on the card on each visit . A standardized explanation on the HbA1c result was given to each participant(e.g. the HbA1c result is normal or high and the HbA1c result had improved or worsen)

The patient will be seen at 3- month and 6-month. So the total duration of follow up was 6 months.

At the end of the study, the patient will keep the card.
Intervention code [1] 269142 0
Other interventions
Comparator / control treatment
A table measured 11cm x 11cm with 3 columns and 7 rows was printed on a ivory white card measured 21cmx24cm.The card was covered with a blue colour paper printed with title “HbA1c Card” and the researcher name plus the phone number.

The tool used in the control arm were adapted from the diabetes passport used by the Malaysian Ministry of Health . The dates and HbA1c results were recorded in numerical form in the corresponding row.


The patient in the HbA1c recording table group will received the card at the recruitment day. They will keep the card and bring it during the follow up day. The researcher will update the HbA1c reading on the card on each visit .

A standardized explanation on the HbA1c result was given to each participant(e.g. the HbA1c result is normal or high and the HbA1c result had improved or worsen)

The patient will be seen at 3- month and 6-month. So the total duration of follow up was 6 months.

At the end of the study, the patient will keep the card.
Control group
Active

Outcomes
Primary outcome [1] 269381 0
evaluate the effectiveness of colour coded HbA1c recording- graph in improving diabetes control as compared to HbA1c-recording table.

the effectiveness was assessed by using the mean improvement in the HbA1c result at 6-month comparing the HbA1c recording graph group and the HbA1c recording table group.

The result was analyzed using the student-t test
Timepoint [1] 269381 0
6 month
Secondary outcome [1] 287517 0
The pairwise difference in the mean changes in HbA1c result within the group over time (Compared mean HbA1c result at baseline, 3 month and 6 month follow up visit).
Timepoint [1] 287517 0
6 month
Secondary outcome [2] 287518 0
The magnitude of improvement in the mean HbA1c knowledge score between the groups at 3- month follow up visit.

THe Hba1c knowledge was assessed using the questionnaire. It comprised of three questions:
1)Do you know about HbA1c?
2)From your understading,HbA1c level represents the control over how long?
3)In your opinion, the normal HbA1c level is less than__________________

After the assessment, patients were grouped into: do not understand HbA1c, partial understanding and good understanding on HbA1c.

Patients were classified as
1)Do not understand. HbA1c if they answered" no" for question no 1 above.
2)Partial understanding. implies correct answer was given for duration of control or for the target level of HbA1c.
3)Good understanding. implies correct answers were given for both the duration of control and the target level of HbA1c.

"Three months duration" was accepted as the correct answer for duration of control.

Hba1c level of either 6.5% or 7% were accepted as the correct answer for level of HbA1c. The reason for having two correct answers for target HbA1c was:
HbA1c target level of 6.5% was the target level stated in the recent Malaysian practice guideline. The target HbA1c was recently changed 7.0% to 6.5%. After reviewing the evidence available, I had put the target level at 7.0%. As such HbA1c value of 7.0% or 6.5% was taken as the correct answer for target HbA1c level.

Those who answered the two questions correctly will score "two" marks.The score was is "one" if they only answered one question correctly or zero if all the answers was wrong.

The same set of questionnaires was administrated twice to score the participant knowledge, first time during the recruitment and second time during the 3- month follow up.

the mean of improvement in the score was
obtained and the result was analysed using the paired t-test.
Timepoint [2] 287518 0
3 month

Eligibility
Key inclusion criteria
patients diagnosed with type 2 diabetes for at least 1 year; recent HbA1c result > 7.0%; and can read and comprehend numbers.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with disabilities and debilitating illness( e.g. cancer, severe heart failure, end stage renal failure, blindness, colour blind, major psychiatric illness, dementia, stroke which affects the cognitive function, tetraplegia.) or on any medications that might interfere with the sugar control, such as corticosteroid, were excluded from the study.

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)
Recruitment
Written invitation were given to the diabetes patients who had HbA1c level >7%. Patient who were willing to participate would be screened. A written consent was taken from those who fulfill the research criteria.

Randomization
Patients who consented to participate were then randomized using the thick envelope method in blocks .The sequence was generated by a research assistant who was not involved in the recruitment and implementation process. Thick envelopes were then numbered in ascending order according to the sequence generated. Allocation was carried out according to the number in ascending order. Both the researcher and patient were blinded until the intervention was assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
thick envelope method
Masking / blinding
Open (masking not 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
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 3774 0
Malaysia
State/province [1] 3774 0
kuala lumpur

Funding & Sponsors
Funding source category [1] 269618 0
University
Name [1] 269618 0
University Malaya
Country [1] 269618 0
Malaysia
Primary sponsor type
University
Name
University Malaya
Address
Lembah Pantai,
59100 Kuala Lumpur,
Malaysia
Country
Malaysia
Secondary sponsor category [1] 266650 0
None
Name [1] 266650 0
Address [1] 266650 0
Country [1] 266650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269567 0
Medical Ethics Committee, University Malaya Medical Centre
Ethics committee address [1] 269567 0
Lembah Pantai,
59100 Kuala Lumpur,
Malaysia
Ethics committee country [1] 269567 0
Malaysia
Date submitted for ethics approval [1] 269567 0
13/10/2008
Approval date [1] 269567 0
26/11/2008
Ethics approval number [1] 269567 0
1/02/0691

Summary
Brief summary
This was a randomized control trial carried out in the primary care clinic in University Malaya Medical Centre, Malaysia.
Trial website
nil
Trial related presentations / publications
The study was presented during the thesis defense for master candidate
Public notes

Contacts
Principal investigator
Name 32988 0
Address 32988 0
Country 32988 0
Phone 32988 0
Fax 32988 0
Email 32988 0
Contact person for public queries
Name 16235 0
STALIA WONG SIEW LEE
Address 16235 0
Primary Care Department,
University Malaya Medical Centre,
Lembah Pantai,
59100 Kuala Lumpur.
Country 16235 0
Malaysia
Phone 16235 0
600123271517
Fax 16235 0
Malaysia
Email 16235 0
staliawong@yahoo.com
Contact person for scientific queries
Name 7163 0
Stalia Wong Siew Lee
Address 7163 0
Primary Care Department,
University Malaya Medical Centre,
Lembah Pantai,
59100 Kuala Lumpur.
Country 7163 0
Malaysia
Phone 7163 0
600123271517
Fax 7163 0
Malaysia
Email 7163 0
staliawong@yahoo.com

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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