Peer Comparison-based Risk Communication (PRICOM)

February 14, 2025 updated by: Ong Ruiheng, SingHealth Polyclinics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 469662
        • SingHealth Polyclinics - Bedok Polyclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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)
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.
No Intervention: Control
The control group will receive a diabetes pamphlet at their routine clinic appointment but will not attend a PRICOM session.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SingHealth Polyclinics

Investigators

  • Principal Investigator: Ruiheng Ong, SingHealth Polyclinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Actual)

January 22, 2024

Study Completion (Actual)

August 29, 2024

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-2306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only IPD used in the results publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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