Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000113651
Ethics application status
Approved
Date submitted
29/12/2022
Date registered
1/02/2023
Date last updated
1/02/2023
Date data sharing statement initially provided
1/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of an Insulin Therapy Education Intervention (ITEI) on Insulin Adherence among Patients with Type 2 Diabetes Mellitus: A Randomized Control Trial
Scientific title
Effectiveness of an Insulin Therapy Education Intervention (ITEI) on Insulin Adherence among Patients with Type 2 Diabetes Mellitus: A Randomized Control Trial
Secondary ID [1] 308521 0
RSCH ID-22-05358-KDD
Universal Trial Number (UTN)
Trial acronym
ITEI (Insulin Therapy Education Intervention)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 328346 0
Adherence toward insulin therapy 328347 0
Condition category
Condition code
Metabolic and Endocrine 325386 325386 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants in this study are adults with type 2 Diabetes mellitus (T2DM) who have poor adherence towards insulin therapy. Participants must receive insulin therapy minimum for 1 year and need to attend sessions for ITEI health education module by a diabetes educator, need to give a 3ml blood sample (HbA1c) in the first weeks, 12th weeks and 24th weeks during this six-month duration of the study.


There is a three-part session of the ITEI Module, which is parts 1, 2, and 3. all three parts will be incorporated into each session. Method delivery of this education intervention include physical (face to face) discussion/consultation involve demonstration, motivational interviewing, virtual consultation and provide interactive video and slide. All material include of slide and video been provided and designed for this study. All material go through the validation phase among 4 expertise person ( Endocrinologist, Dietitian, Diabetes Educator, family medicine specialist) in this endocrine fields. The content of education for this study call as Insulin Therapy Education Intervention (ITEI).

The frequency of the session is once a months for the face to face session covering all the parts, Meanwhile within 2 weeks for the virtual consultation/ phone consultation for review self monitoring blood sugar and provide interactive video/slide. All session will be run individually and time is flexible according the patient availability time. Attendance will be monitored, if patient absent the next appointment will be reschedule. The strategy to monitored adherences is using questionnaire (Adherences Scale assessment) every 2 months.

Part One:
Part one will start with setting up the mutual agreement for care. A patient will be given a personal diary to list down the goal, methods to achieve the target, and reasons to be analysed if the target is not achieved. Health Education will be covered a topic on nine topics of health education that are currently used same with the control group (Diabetes, medication, diabetes emergency, exercises, footcare, self-monitoring blood glucose, wound care, insulin), diabetes distress, approaching and involving peer support to helping the client in managing diabetes.

Part two:
Part two of ITEI, the session will cover empowerment on diabetes self-care -motivational section session using Health belief model and Theories of Learning &Behaviourism to understand the content of health education that has been delivered, insulin injection technique demonstration and competency (practical section), lipodystrophy recognition, insulin storage practices, insulin adjustment/titration, a home task for self-monitoring blood glucose (SMBG), telephone consultation for any issued update, simple relaxation section technique base on the result of diabetes distress and Depression Anxiety Stress Scale (DASS). Lastly, the patient will be updating analysing personal diary targets based on a personal objective that has been set up before.

Part Three:
The last part of the ITEI module will be covering on problem-solving, stress management, planning intervention, and motivational section. Each education session will take minimally 30 minutes and a maximum of 2 hours for each activities/consultation. Telephone consultation will be taken within five to 10 minutes , however may be longer according to patient needs.

Participant will be giving questionnaire on knowledge on insulin, adherence, diabetes distress and mental status (depression, anxiety, stress) and insulin injection technique competency as well as HbA1c will taking on pre (1st week), middle (12th week) and end (24th week).

Intervention code [1] 324961 0
Behaviour
Intervention code [2] 324962 0
Lifestyle
Comparator / control treatment
The control group will receive a standard routine as the clinic session includes a regular education routine. Health Education will be covered on nine topics of health education that are currently used in Malaysian practice (Diabetes, medication, diabetes emergency, exercises, footcare, self-monitoring blood glucose, wound care, insulin injection). Participant will be giving questionnaire on knowledge on insulin, adherence, diabetes distress and mental status (depression, anxiety, stress) and insulin injection technique competency as well as HbA1c will taking on pre (1st week), middle (12th week) and end (24th week).

The training using video , flipchart for the health educations . Meanwhile the duration of the session is 30 minutes session every months over the 24 weeks. The mode of education delivery is individual. The strategy to monitored adherences is using questionnaire (Adherences Scale assessment) every 2 months.

This comparator group will received education material from multiple resources that currently been used in clinic. The resources of material already available and been used among clinic health care provider for educate patients. The source material name is "Health Education for diabetes patients".
Control group
Active

Outcomes
Primary outcome [1] 333239 0
HbA1c Level : A hemoglobin A1C (HbA1C) test is a blood test that shows what your average blood sugar (glucose) level was over the past two to three months.
This outcome will assess using serum HbA1c.
Timepoint [1] 333239 0
All outcome will be measure at :
At the 1st weeks(baseline)
12th weeks during commencement of interventions
and 24th weeks post commencement of interventions

The primary timepoint at the 24th weeks post commencement of interventions.
Primary outcome [2] 333240 0
Adherence level:

This part of the section will be asking about level adherence and using a questionnaire Malaysia Medication Adherence Assessment Tool (MyMAAT) for diabetic patients. The MyMAAT score was the total of the marks for the individual items.
Timepoint [2] 333240 0
All outcome will be measure at :
At the 1st weeks(baseline)
12th weeks during commencement of interventions
and 24th weeks post commencement of interventions

The primary timepoint at the 24th weeks post commencement of interventions.
Primary outcome [3] 333241 0
Using Diabetes Knowledge Test that has been formulated for assessing diabetes knowledge. However, only 9 questions will be taken from this questionnaire which is focused on insulin field.
Timepoint [3] 333241 0
All outcome will be measure at :
At the 1st weeks(baseline)
12th weeks during commencement of interventions
and 24th weeks post commencement of interventions

The primary timepoint at the 24th weeks post commencement of interventions.
Secondary outcome [1] 416318 0
Assessment of Insulin competency on Insulin Injection technique.

Consist of 11 questions on injection technique using pen devices. The answer "Yes =1", and "No=0". The sum score ranges from 0 to 11 with higher scores indicating a higher level of good competency. This questionnaire was adapted from Checklist Forum for injection technique – Malaysia (FIT-MY), (2017).
Timepoint [1] 416318 0
All outcome will be measure at :
At the 1st weeks(baseline)
12th weeks during commencement of interventions
and 24th weeks post commencement of interventions
Secondary outcome [2] 416319 0
Depression Anxiety Stress Scale (DASS) :

This part consists of the 21 Items (DASS-21) questionnaire with Malay and English version were consist of a set of self-reporting scales to measure stress, anxiety, and depression. The questionnaire took Ministry of Health MOH (DASS Screening) The higher score indicates the greater level of depression, anxiety, and stress.

Timepoint [2] 416319 0
At the 1st weeks(baseline)
12th weeks during commencement of interventions
and 24th weeks post commencement of interventions
Secondary outcome [3] 417839 0
Diabetes distress Questionnaire:
Diabetes Distress scale (DDS) is a 17-item scale that captures four critical dimensions of. distress: emotional burden, regimen distress, interpersonal distress, and physician distress. To score, simply sum the patient’s responses to the appropriate items and divide by the number of items in that scale. Mean item score 2.0 – 2.9 should be considered ‘moderate distress,’ and a mean item score > 3.0 should be considered ‘high distress.’
Timepoint [3] 417839 0
At the 1st weeks(baseline)
12th weeks during commencement of interventions
and 24th weeks post commencement of interventions

Eligibility
Key inclusion criteria
• Poor adherences level towards medication/Insulin
• Poor knowledge on Medication/Insulin
• Not presenting of complications (Retinopathy, Stroke, Neuropathy, Nephropathy),
• Having glucometer machine
• Have access to mobile contact
• Making self-injecting insulin which is not asking help for others person
• Used insulin pen as devices at least for one years of durations.
. Type 2 DM
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Good adherences to medication/insulin
• Using syringe as method of administered insulin
• Present with complications (Retinopathy, Stroke, Neuropathy, Nephropathy).
• Pregnant

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization will be using in this study which is the group allocation will be determined randomly and will be allocate either intervention or control group with probability of 0.5 (Campbell & alters, 2014) from beginning until end of the intervention regardless of whether they withdraw from the study.
Simple randomization using procedures tossing a coin for each subject that enters a trial
This method is using tossing a coin for each subject that enters a trial, which are: -
a. Heads = Control group
b. Tails = Intervention group
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

The participant will be analyzed according to their group allocations, and intervention will be applied accordingly to maintain the reliability and internal validity to prevent errors in the randomized process.
SPSS version 26 will be used to run the analysis. Data will be present in percentage and frequency for part of the descriptive analysis. Meanwhile, the normality test will be run before using parametric and non – parametric tests to meet the objective of the study.

For sample and size calculation in this study, the researcher will be using formula comparison between group experimental design as recommended by Riffenburgh (2012), which have the same set of numbers for both groups. The calculation is derived from an experimental study of medication compliances among T2DM with a significant level of 0.05 with a power of 80% (Papsamut et al.,2002; Supachaipanichpong et al.,2018). A total of 86 samples will be recruited, of which 43 participants will be allocated randomly for each group groups.

The Mapping objective Of Research, Analyses Data and Variables of Research.
Objective:a) To examine the effect of ITEI intervention on the level of HbA1c, knowledge, adherence, insulin injection technique competency, diabetes distress and mental status (Depression, Anxiety Stress), and level among type 2 diabetes mellitus patients.

Test/analyse: This objective will be analyzed using multiple linear regression / Split-Plot ANOVA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment outside Australia
Country [1] 25161 0
Malaysia
State/province [1] 25161 0
Selangor

Funding & Sponsors
Funding source category [1] 312759 0
Self funded/Unfunded
Name [1] 312759 0
Nur Shazwaniza Yahya
Country [1] 312759 0
Malaysia
Primary sponsor type
Individual
Name
Nur Shazwaniza Yahya
Address
Pangsapuri A, 1-2 Kuarters Klinik Kesihatan Sungai Buloh, 47000 Sungai Buloh Selangor
Country
Malaysia
Secondary sponsor category [1] 314395 0
None
Name [1] 314395 0
-
Address [1] 314395 0
-
Country [1] 314395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312061 0
Research Ethics Committee of Universiti Teknologi MARA(UiTM)
Ethics committee address [1] 312061 0
Ethics committee country [1] 312061 0
Malaysia
Date submitted for ethics approval [1] 312061 0
05/01/2022
Approval date [1] 312061 0
18/07/2022
Ethics approval number [1] 312061 0
REC/07/2022 (PG/FB/16)

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

Contacts
Principal investigator
Name 123322 0
Miss Nur Shazwaniza Binti Yahya
Address 123322 0
Pangsapuri A, 1-2 Quarters Clinic Sungai Buloh, Kampung Melayu Sungai Buloh, 47000 Sungai Buloh, Selangor, Malaysia.
Country 123322 0
Malaysia
Phone 123322 0
+600193128825
Fax 123322 0
-
Email 123322 0
[email protected]
Contact person for public queries
Name 123323 0
Dr. Zamzaliza Abd. Mulud
Address 123323 0
Faculty of Health Sciences, Universiti Teknologi MARA, 42300 Bandar Puncak Alam, Selangor, Malaysia.
Country 123323 0
Malaysia
Phone 123323 0
+600193128825
Fax 123323 0
-
Email 123323 0
[email protected]
Contact person for scientific queries
Name 123324 0
Dr. Ahmad Zamir Che Daud
Address 123324 0
Faculty of Health Sciences, Universiti Teknologi MARA, 42300 Bandar Puncak Alam, Selangor, Malaysia.
Country 123324 0
Malaysia
Phone 123324 0
+601119277577
Fax 123324 0
-
Email 123324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17946Ethical approval    UiTM ethical approval 385066-(Uploaded-29-12-2022-16-11-25)-Study-related document.pdf



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.