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Trial registered on ANZCTR


Registration number
ACTRN12620000381987
Ethics application status
Approved
Date submitted
25/02/2020
Date registered
20/03/2020
Date last updated
20/03/2020
Date data sharing statement initially provided
20/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a brief illness perception intervention improve adherence and glycemic control in patients with type 2 diabetes?
Scientific title
A brief illness perception intervention to improve adherence and glycemic control in patients with type 2 diabetes: A randomised controlled trial
Secondary ID [1] 291826 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 315906 0
Condition category
Condition code
Metabolic and Endocrine 314178 314178 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with poorly controlled type 2 diabetes and nominated family members will be randomised to receive either the intervention described below plus standard care (intervention group), or standard care plus standard diabetes pamphlets (control group).

The intervention consists of three main components: (1) discussion about illness perceptions and beliefs about diabetes medication including patient education, (2) an animated video describing type 2 diabetes and treatment, and (3) a personalized action plan and discussion of barriers to behaviour change.

The starting point for the intervention is a discussion about illness perceptions and beliefs about medication of type 2 diabetes held by the patient and the family member assessed before the intervention. During this discussion, illness perception dimensions and beliefs regarding the necessity of diabetes medication and concerns about side effects and how they can affect self-care behaviours will be explored. Maladaptive perceptions and beliefs will be challenged by providing medical explanations regarding type 2 diabetes and its treatment.

Patients and their family members will then be asked to watch a brief animated video of type 2 diabetes on an iPad provided by the researcher. The animated video is being developed in consultation with endocrinologists in New Zealand and Saudi Arabia. The video will show the inside of the body, how glucose and insulin interact, what goes wrong when you have type 2 diabetes, and how the treatment can control blood glucose levels.

Finally, a written personalised action plan to improve patient’s adherence to Metformin, healthy eating, and exercise will be developed in collaboration with the patient and their family member. Barriers to adaption of the behaviours will be discussed and taken into account. The intervention group will also be given written information about type 2 diabetes and self-care to take home.

The intervention will be structured (e.g. participants watch the same animated video of type 2 diabetes) but also individually tailored to each patient (discussion about illness perceptions and developing a personalised action plan). This brief intervention will consist of one face-to-face session (90 minutes) with patients with type 2 diabetes and their nominated family members and a follow up phone call (10-15 minute) one week later with the patient only. The intervention will be delivered by the primary researcher.
Intervention code [1] 316581 0
Behaviour
Intervention code [2] 317081 0
Treatment: Other
Comparator / control treatment
Patients and family members randomly assigned to the control group will receive standard care plus standard diabetes pamphlets. Diabetes standard care in Saudi Arabia is the standard care as per the American Diabetes Association (ADA) guidelines (American Diabetes Association, 2020). Diabetes pamphlets are standard pamphlets provided by the Saudi National Diabetes Prevention and Control Program (National Diabetes Prevention and Control Program, 2020). The researcher will spend time (up to 90 minutes) with the control group to go through the pamphlets and answer any questions.
Control group
Active

Outcomes
Primary outcome [1] 322566 0
Glycemic control (Glycosylated hemoglobin/A1c) will be assessed at the diabetes clinic as part of standard care. HbA1c is tested using Dimension® Flex Reagent Cartridge HB1C device provided by Siemens HealthCare Diagnostic Inc (USA). It measures HbA1c based on Turbidimetric Inhibition Immunoassay (TINIA) method.
Timepoint [1] 322566 0
At baseline, 3 months [primary timepoint] and 6 months after baseline
Primary outcome [2] 322567 0
Illness perceptions will be assessed using the Arabic version of the Brief Illness Perception Questionnaire (B-IPQ) (Broadbent et al., 2006)
Timepoint [2] 322567 0
Baseline, post intervention [primary timepoint], 3 months and 6 months after baseline
Secondary outcome [1] 378961 0
Adherence to Metformin will be assessed using the Arabic version of the Medication Adherence Report Scale (MARS-5) (Horne et al., 1999; Horne & Weinman, 2002) and the modified Medication Possession Ratio (mMPR)
Timepoint [1] 378961 0
MARS-5: at baseline, 3 and 6 months after baseline
mMPR: at 3 and 6 months after baseline
Secondary outcome [2] 378977 0
Adherence to healthy eating and exercise will be assessed using the Arabic version of the general diet, specific diet, and exercise items of the Arabic version of the Summary of Diabetes Self-Care Activities (SDSCA) (Toobert et al., 2000)
Timepoint [2] 378977 0
Baseline, 3 and 6 months after baseline
Secondary outcome [3] 378978 0
Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire-Specific (BMQ-specific) (Horne et al., 1999)
Timepoint [3] 378978 0
Baseline, post intervention, 3 and 6 months after baseline
Secondary outcome [4] 381088 0
Family members illness perceptions will be assessed using the Arabic version of the Brief Illness Perception Questionnaire (B-IPQ) (Broadbent et al., 2006)
Timepoint [4] 381088 0
Post-intervention only
Secondary outcome [5] 381109 0
Satisfaction with the intervention will be assessed by a 4-item questionnaire based on previous studies.

The first three items will assess patients’ overall satisfaction with the information, the amount of information, and their understanding of the information. These items are scored on 11-point Likert scale. The fourth item will ask patients whether they would recommend the intervention to other patients with T2D (yes/no). Higher scores indicate greater satisfaction.

Questions are:
Overall, please rate how satisfied you were with the information you received concerning your type 2 diabetes?
Please rate how satisfied you were with the amount of information that you received?
Please rate how well you understood the information that was given about your type 2 diabetes?
Would you recommend the intervention to other patients with type 2 diabetes?
Timepoint [5] 381109 0
At the end of intervention session

Eligibility
Key inclusion criteria
Patients with poorly controlled type 2 diabetes will be included in this trial if they are (1) over 18 years of age (2) have type 2 diabetes for 1 year and longer (3) have poor glycaemic control (defined as glycosylated haemoglobin (A1c) concentration greater than or equal to 64 mmol/mol or 8% in the last two readings), and (4) are prescribed Metformin.

Any participating family members will have to be over the age of 18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are (1) pregnant (2) have life-threatening illness (e.g. cancer), and (3) not prescribed Metformin.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation using block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
To keep patients and nominated family members blinded to group allocation, they will be told that they will be randomly assigned to one of two groups to receive information about type 2 diabetes, without any further details regarding the treatment.

For glycemic control (primary outcome), group allocation will be concealed from the nurse taking blood samples and from the laboratory staff analysing the blood.
Illness perceptions (primary outcome) and all secondary outcomes will be measured at post-intervention and 3 & 6 months follow up by a research assistant blinded to group allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the sample characteristics. Differences in HbA1c, illness perceptions, adherence to Metformin, healthy eating, exercise, and beliefs about medicine between the intervention and control group will be analysed for the three time-points (baseline, 3-months and 6-months post-intervention). Statistical analysis will use general linear mixed models for continuous outcomes and generalised linear mixed models for binary outcomes. Statistical significance will be taken at the 5% level.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
31/08/2020
Actual
Date of last data collection
Anticipated
28/02/2021
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment outside Australia
Country [1] 22243 0
Saudi Arabia
State/province [1] 22243 0
Najran

Funding & Sponsors
Funding source category [1] 304738 0
Government body
Name [1] 304738 0
King Salman Scholarship Program, Ministry of Health, Saudi Arabia
Country [1] 304738 0
Saudi Arabia
Primary sponsor type
Individual
Name
Professor Elizabeth Broadbent
Address
Auckland Hospital- Building 599
2 Park Rd, Grafton
Auckland 1023, New Zealand
Phone +64 9 3737599
Fax +64 9 3737013
Country
New Zealand
Secondary sponsor category [1] 295253 0
None
Name [1] 295253 0
Address [1] 295253 0
Country [1] 295253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297555 0
Saudi Ministry of Health Institutional Review Board
Ethics committee address [1] 297555 0
Ethics committee country [1] 297555 0
Saudi Arabia
Date submitted for ethics approval [1] 297555 0
Approval date [1] 297555 0
20/01/2020
Ethics approval number [1] 297555 0
Central IRB 20–08E

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

Contacts
Principal investigator
Name 74422 0
Prof Elizabeth Broadbent
Address 74422 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
Country 74422 0
New Zealand
Phone 74422 0
+64 9 3737599
Fax 74422 0
+64 9 3737013
Email 74422 0
[email protected]
Contact person for public queries
Name 74423 0
Elizabeth Broadbent
Address 74423 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
Country 74423 0
New Zealand
Phone 74423 0
+64 9 3737599
Fax 74423 0
+64 9 3737013
Email 74423 0
[email protected]
Contact person for scientific queries
Name 74424 0
Elizabeth Broadbent
Address 74424 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland
Country 74424 0
New Zealand
Phone 74424 0
+64 9 3737599
Fax 74424 0
+64 9 3737013
Email 74424 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?

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.