An interventional study of Peer comparison-based Risk Communication (PRICOM) in Diabetes Type 2, sponsored by SingHealth Polyclinics. Completed at 1 site in Singapore. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by SingHealth Polyclinics · Not applicable, Interventional, and Supportive care
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →SingHealth Polyclinics is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
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Eligibility criteria for patient participation:
Exclusion criteria for patient participation:
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.
Other: Peer comparison-based Risk Communication (PRICOM)
The control group will receive a diabetes pamphlet at their routine clinic appointment but will not attend a PRICOM session.
Based on the Health Belief Model, a risk communication intervention, Peer comparison-based Risk Communication (PRICOM), was developed for primary care physicians to counsel patients with T2DM on their glycaemic control and the complications that could arise, and to recommend ways to improve glycaemic control and prevent complications (or further complications). This will be supported by information from an AI (Artificial Intelligence) based diabetes tool. PRICOM aims to promote health actions in patients with T2DM by increasing their risk perceptions of diabetes complications.
Risk perception score change
Score change of RPS-DM (Risk Perception Scale - Diabetes Mellitus) questionnaire
Time frame: 6 months
Recruitment rate
% patients eligible to participate who were recruited
Time frame: 6 months
Retention rate
% patient participants who completed the study
Time frame: 6 months
Self-care activity score change
Score change of SDSCA (Summary of Diabetes Self-Care Activities) questionnaire
Time frame: 6 months
Medication adherence score change
Score change of MARS-5 (5-item Medication Adherence Report Scale) questionnaire
Time frame: 6 months
HbA1c change
Change in HbA1c value
Time frame: 6 months
Perspectives of PRICOM
Time frame: 6 months
Plan to share: Yes — Only IPD used in the results publication
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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SingHealth Polyclinics