Peer Comparison-based Risk Communication (PRICOM)

SingHealth Polyclinics

Status: Completed

Conditions: Diabetes Type 2

Treatments: Other: Peer comparison-based Risk Communication (PRICOM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06837428

2023-2306

Details and patient eligibility

About

The study objective is to evaluate the feasibility of delivering a risk communication intervention, Peer comparison-based Risk Communication (PRICOM), in the primary care setting for adults with poor T2DM control. Findings from the study will inform further revisions to PRICOM and provide an estimated effect size to estimate the required sample size for a multi-site trial.

Full description

Background: Younger adults with Type 2 Diabetes Mellitus (T2DM) in Singapore tend to have poorer glycaemic control and medication adherence, factors correlating with high risk of diabetes complications. Late-stage diabetes and its complications are perceived to be slow-progressing and not immediately life-threatening. These reflect a concerning state of diabetes control and risk perception in Singapore. Using the Health Belief Model, a risk communication intervention, Peer comparison-based Risk Communication (PRICOM), was developed for physicians to counsel patients with T2DM supported by a digital tool. PRICOM aims to promote health actions by increasing their risk perceptions of diabetes complications.

Specific aims: The primary aim is to evaluate the feasibility of delivering PRICOM in the primary care setting for adults with poor T2DM control - in terms of recruitment, retention, PRICOM adherence, estimated effect size of score changes in risk perception, health actions and HbA1c change. Secondary aims are to assess validity of the risk perception scale, and to explore patients' perspectives of PRICOM.

Methodology: A multi-site randomised controlled trial will be conducted at a primary care clinic in 2 concurrent phases. In phase 1, content validation and test-retest reliability of a risk perception scale will be carried out. In phase 2, a two-arm randomised controlled trial will be conducted using mixed-methods to evaluate the feasibility of delivering PRICOM. A total 40 patient participants will be recruited by convenience sampling. Eligible patients must be age 40-79 years and have poor T2DM control with at least one HbA1c reading ≥ 8.0% within the last 6 months.

Relevance/significance of the study: Findings from the study will inform further revisions to PRICOM and provide an estimated effect size to estimate the required sample size for a multi-site trial.

Enrollment: 40 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility criteria for patient participation:

• T2DM on follow-up at the respective study site for at least 12 months
• Age 40 to 79 years
• At least one HbA1c reading ≥ 8.0% within the last 6 months
• Able to read and speak English

Exclusion criteria for patient participation:

• Not a Singapore citizen or permanent resident
• Pregnant
• End-stage kidney disease or on renal replacement therapy
• Known terminal illness
• Visual and/or hearing impairment
• Cognitive impairment or mental illness
• Unable to provide informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group will attend a risk communication session delivered by the study team and will receive a diabetes pamphlet. This estimated to take 10-15 minutes and will be back-to-back with the patient's routine clinic appointment.

Treatment:

Other: Peer comparison-based Risk Communication (PRICOM)

Control

No Intervention group

Description:

The control group will receive a diabetes pamphlet at their routine clinic appointment but will not attend a PRICOM session.