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Can a brief illness perception intervention improve adherence and glycemic control in patients with type 2 diabetes?

A brief illness perception intervention to improve adherence and glycemic control in patients with type 2 diabetes: A randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000381987
Enrollment
126
Registered
2020-03-20
Start date
2020-06-01
Completion date
2020-08-31
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial aims to evaluate whether a brief illness perception intervention can improve patients’ glycemic control, illness perceptions, beliefs about diabetes medicine, adherence to Metformin, healthy eating, and exercise compared to diabetes standard care plus standard diabetes pamphlets in Saudi Arabia. Changes in family members perceptions will also be assessed.

Interventions

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 personali

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.

Sponsors

Professor Elizabeth Broadbent
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Patients will be excluded if they are (1) pregnant (2) have life-threatening illness (e.g. cancer), and (3) not prescribed Metformin.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026