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Completed

NCT Number: NCT06837428

Peer Comparison-based Risk Communication

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.

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Key information

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SingHealth Polyclinics - Bedok Polyclinic

Singapore, 469662

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Risk perception score change

    Time frame: 6 months

    Score change of RPS-DM (Risk Perception Scale - Diabetes Mellitus) questionnaire

  2. Recruitment rate

    Time frame: 6 months

    % patients eligible to participate who were recruited

  3. Retention rate

    Time frame: 6 months

    % patient participants who completed the study

Secondary outcomes

  1. Self-care activity score change

    Time frame: 6 months

    Score change of SDSCA (Summary of Diabetes Self-Care Activities) questionnaire

  2. Medication adherence score change

    Time frame: 6 months

    Score change of MARS-5 (5-item Medication Adherence Report Scale) questionnaire

  3. HbA1c change

    Time frame: 6 months

    Change in HbA1c value

  4. Perspectives of PRICOM

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

SingHealth Polyclinics

Other

Registry information

Official study title

Peer Comparison-based Risk Communication (PRICOM): A Study Protocol to Evaluate the Feasibility of Delivering a Risk Communication Intervention in the Primary Care Setting for Adults With Type 2 Diabetes Mellitus

Acronym: PRICOM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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