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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- SingHealth Polyclinics
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Recruitment rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Arms & Interventions
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.
Intervention: Peer comparison-based Risk Communication (PRICOM) (Other)
Control
The control group will receive a diabetes pamphlet at their routine clinic appointment but will not attend a PRICOM session.
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: 6 months
% patients eligible to participate who were recruited
Risk perception score change
Time Frame: 6 months
Score change of RPS-DM (Risk Perception Scale - Diabetes Mellitus) questionnaire
Retention rate
Time Frame: 6 months
% patient participants who completed the study
Secondary Outcomes
- Self-care activity score change(6 months)
- Medication adherence score change(6 months)
- HbA1c change(6 months)
- Perspectives of PRICOM(6 months)
Investigators
Ong Ruiheng
Principal Investigator
SingHealth Polyclinics