Diabetes Type 2
Conditions
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.
Interventions
OTHERPeer 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.
Sponsors
SingHealth Polyclinics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk perception score change | 6 months | Score change of RPS-DM (Risk Perception Scale - Diabetes Mellitus) questionnaire |
| Recruitment rate | 6 months | % patients eligible to participate who were recruited |
| Retention rate | 6 months | % patient participants who completed the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-care activity score change | 6 months | Score change of SDSCA (Summary of Diabetes Self-Care Activities) questionnaire |
| Perspectives of PRICOM | 6 months | — |
| Medication adherence score change | 6 months | Score change of MARS-5 (5-item Medication Adherence Report Scale) questionnaire |
| HbA1c change | 6 months | Change in HbA1c value |
Countries
Singapore
Outcome results
None listed