跳至主要内容
临床试验/NCT06837428
NCT06837428已完成不适用

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

SingHealth Polyclinics1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Recruitment rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •for patient participation:
  • •Not a Singapore citizen or permanent resident
  • •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

研究组 & 干预措施

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.

干预措施: Peer comparison-based Risk Communication (PRICOM) (Other)

Control

No Intervention

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

结局指标

主要结局

Recruitment rate

时间窗: 6 months

% patients eligible to participate who were recruited

Risk perception score change

时间窗: 6 months

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

Retention rate

时间窗: 6 months

% patient participants who completed the study

次要结局

  • Self-care activity score change(6 months)
  • Medication adherence score change(6 months)
  • HbA1c change(6 months)
  • Perspectives of PRICOM(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ong Ruiheng

Principal Investigator

SingHealth Polyclinics

研究点 (1)

Loading locations...

相似试验

Peer Comparison-based Risk Communication | 临床试验