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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Control | No Intervention | The control group will receive a diabetes pamphlet at their routine clinic appointment but will not attend a PRICOM session. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer comparison-based Risk Communication (PRICOM) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk perception score change | Score change of RPS-DM (Risk Perception Scale - Diabetes Mellitus) questionnaire | 6 months |
| Recruitment rate | % patients eligible to participate who were recruited | 6 months |
| Retention rate | % patient participants who completed the study | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-care activity score change | Score change of SDSCA (Summary of Diabetes Self-Care Activities) questionnaire | 6 months |
| Medication adherence score change | Score change of MARS-5 (5-item Medication Adherence Report Scale) questionnaire |
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Eligibility criteria for patient participation:
Exclusion criteria for patient participation:
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| Name | Affiliation | Role |
|---|---|---|
| Ruiheng Ong | SingHealth Polyclinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SingHealth Polyclinics - Bedok Polyclinic | Singapore | 469662 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26880337 | Background | Png ME, Yoong J, Phan TP, Wee HL. Current and future economic burden of diabetes among working-age adults in Asia: conservative estimates for Singapore from 2010-2050. BMC Public Health. 2016 Feb 16;16:153. doi: 10.1186/s12889-016-2827-1. | |
| 35232779 | Background | Roystonn K, Lau JH, AshaRani PV, Siva Kumar FD, Wang P, Sum CF, Lee ES, Chong SA, Subramaniam M. Recognition of diabetes and sociodemographic predictors: results of a cross-sectional nationwide population-based survey in Singapore. BMJ Open. 2022 Mar 1;12(3):e050425. doi: 10.1136/bmjopen-2021-050425. |
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Only IPD used in the results publication
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 6 months |
| HbA1c change | Change in HbA1c value | 6 months |
| Perspectives of PRICOM | 6 months |
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| D004700 | Endocrine System Diseases |