NCT06837428

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 21, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

October 6, 2021

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (4)

  • Self-care activity score change

    6 months

  • Medication adherence score change

    6 months

  • HbA1c change

    6 months

  • Perspectives of PRICOM

    6 months

Study Arms (2)

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.

Other: Peer comparison-based Risk Communication (PRICOM)

Control

NO INTERVENTION

The control group will receive a diabetes pamphlet at their routine clinic appointment but will not attend a PRICOM session.

Interventions

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.

Intervention

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SingHealth Polyclinics - Bedok Polyclinic

Singapore, 469662, Singapore

Location

Related Publications (28)

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    PMID: 35232779BACKGROUND
  • Quah JH, Liu YP, Luo N, How CH, Tay EG. Younger adult type 2 diabetic patients have poorer glycaemic control: a cross-sectional study in a primary care setting in Singapore. BMC Endocr Disord. 2013 Jun 3;13:18. doi: 10.1186/1472-6823-13-18.

    PMID: 23725198BACKGROUND
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    PMID: 28912194BACKGROUND
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    PMID: 32184203BACKGROUND
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    PMID: 36219616BACKGROUND
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    PMID: 10854457BACKGROUND
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    PMID: 17315602BACKGROUND
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    PMID: 14512489BACKGROUND
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    PMID: 22520906BACKGROUND
  • Gao R, Guo H, Liu Y, Pang Y, Zhang X, Lian X, Yu T, Zhu L, Li F. Effects of message framing on self-management behaviour among patients with type 2 diabetes: a randomised controlled trial protocol. BMJ Open. 2022 Jun 28;12(6):e056450. doi: 10.1136/bmjopen-2021-056450.

    PMID: 35768085BACKGROUND
  • Garcia-Retamero R, Okan Y, Cokely ET. Using visual aids to improve communication of risks about health: a review. ScientificWorldJournal. 2012;2012:562637. doi: 10.1100/2012/562637. Epub 2012 May 2.

    PMID: 22629146BACKGROUND
  • Trevena L. Assessing, communicating, and managing risk in general practice. Br J Gen Pract. 2014 Apr;64(621):166-7. doi: 10.3399/bjgp14X677725. No abstract available.

    PMID: 24686863BACKGROUND
  • Welschen LM, Bot SD, Dekker JM, Timmermans DR, van der Weijden T, Nijpels G. The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial. BMC Public Health. 2010 Aug 5;10:457. doi: 10.1186/1471-2458-10-457.

    PMID: 20687924BACKGROUND
  • Welschen LM, Bot SD, Kostense PJ, Dekker JM, Timmermans DR, van der Weijden T, Nijpels G. Effects of cardiovascular disease risk communication for patients with type 2 diabetes on risk perception in a randomized controlled trial: the @RISK study. Diabetes Care. 2012 Dec;35(12):2485-92. doi: 10.2337/dc11-2130. Epub 2012 Aug 24.

    PMID: 22923669BACKGROUND
  • Rouyard T, Leal J, Baskerville R, Velardo C, Salvi D, Gray A. Nudging people with Type 2 diabetes towards better self-management through personalized risk communication: A pilot randomized controlled trial in primary care. Endocrinol Diabetes Metab. 2018 Jun 22;1(3):e00022. doi: 10.1002/edm2.22. eCollection 2018 Jul.

    PMID: 30815556BACKGROUND
  • Mao L, Lu J, Zhang Q, Zhao Y, Chen G, Sun M, Chang F, Li X. Family-based intervention for patients with type 2 diabetes via WeChat in China: protocol for a randomized controlled trial. BMC Public Health. 2019 Apr 5;19(1):381. doi: 10.1186/s12889-019-6702-8.

    PMID: 30953483BACKGROUND
  • Feng Y, Zhao Y, Mao L, Gu M, Yuan H, Lu J, Zhang Q, Zhao Q, Li X. The Effectiveness of an eHealth Family-Based Intervention Program in Patients With Uncontrolled Type 2 Diabetes Mellitus (T2DM) in the Community Via WeChat: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Mar 20;11:e40420. doi: 10.2196/40420.

    PMID: 36939825BACKGROUND
  • Fang HSA, Tan NC, Tan WY, Oei RW, Lee ML, Hsu W. Patient similarity analytics for explainable clinical risk prediction. BMC Med Inform Decis Mak. 2021 Jul 1;21(1):207. doi: 10.1186/s12911-021-01566-y.

    PMID: 34210320BACKGROUND
  • Oei RW, Fang HSA, Tan WY, Hsu W, Lee ML, Tan NC. Using Domain Knowledge and Data-Driven Insights for Patient Similarity Analytics. J Pers Med. 2021 Jul 22;11(8):699. doi: 10.3390/jpm11080699.

    PMID: 34442343BACKGROUND
  • Stefanut AM, Vintila M. Psychotherapeutic intervention on breast self-examination based on Health Belief Model. Curr Psychol. 2022 Feb 21:1-9. doi: 10.1007/s12144-022-02871-z. Online ahead of print.

    PMID: 35221635BACKGROUND
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    PMID: 32755882BACKGROUND
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    PMID: 28508016BACKGROUND
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    PMID: 18639997BACKGROUND
  • Lim DYZ, Chia SY, Abdul Kadir H, Mohamed Salim NN, Bee YM. Establishment of the SingHealth Diabetes Registry. Clin Epidemiol. 2021 Mar 16;13:215-223. doi: 10.2147/CLEP.S300663. eCollection 2021.

    PMID: 33762850BACKGROUND
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    PMID: 9972558BACKGROUND
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    PMID: 31823381BACKGROUND
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    PMID: 10895844BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ruiheng Ong

    SingHealth Polyclinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2021

First Posted

February 20, 2025

Study Start

August 21, 2023

Primary Completion

January 22, 2024

Study Completion

August 29, 2024

Last Updated

February 20, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Only IPD used in the results publication

Locations