Peer Comparison-based Risk Communication

Not Applicable

Completed

• Conditions: Diabetes Type 2

• Registration Number: NCT06837428
• Lead Sponsor: SingHealth Polyclinics

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-06
• Study Start: 2023-08-21
• Primary Completion: 2024-01-22
• Study Completion: 2024-08-29
• Status Verified: 2024-09
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Risk perception score change	6 months	Score change of RPS-DM (Risk Perception Scale - Diabetes Mellitus) questionnaire
Recruitment rate	6 months	% patients eligible to participate who were recruited
Retention rate	6 months	% patient participants who completed the study

Secondary Outcome Measures

Name	Time	Method
Self-care activity score change	6 months	Score change of SDSCA (Summary of Diabetes Self-Care Activities) questionnaire
Medication adherence score change	6 months	Score change of MARS-5 (5-item Medication Adherence Report Scale) questionnaire
HbA1c change	6 months	Change in HbA1c value
Perspectives of PRICOM	6 months

Trial Locations

Locations (1)

SingHealth Polyclinics - Bedok Polyclinic; 🇸🇬 Singapore, Singapore