Better Risk Perception Via Patient Similarity to Control Hyperglycemia and Sustained by Telemonitoring

Condition(s) studied

Investigational drug(s) / intervention(s)

Intervention using an AI enabled risk communication tool (PERDICT.AI): Risk communication using PERDICT.AI dynamically communicates an individual's glycemic control, offering a comparative ranking among peers to enhance motivation and awareness. Furthermore, it assesses the risk of potential complications comparing with peer data with exemplary cases to underscore the consequences of suboptimal management. In addition, it will generate personalized recommendations including medication adjustment and personalized health plans.

Telemonitoring with Primary Tech Enhanced Care (PTEC-DM): The Primary Tech-Enhanced Care (PTEC) programme focuses on encouraging patients to manage chronic conditions at home through user-friendly kits. The Home Diabetes Monitoring programme (PTEC-DM) enables home-based glucose and blood pressure monitoring once a week using a Bluetooth enabled device. These reading will be securely transmitted to the study team via the app and managed appropriately through teleconsultation. Additionally, participants will receive health nudges, encouragements, and reminders through in-app messages to support their well-being.

Study summary

Background: Diabetes significantly raises the likelihood of complications, thereby increasing the risk of diabetes-related mortality, particularly due to vascular complications. It is vital to address this rising trend of mortality, by enhancing awareness of diabetes complications to improve risk perception and ultimately reduce mortality rates. Managing diabetes effectively requires interventions addressing both risk communication and monitoring, helping patients better understand and make informed decisions about their health.

Objectives: The primary aim is to evaluate and compare the effectiveness of combined risk communication session using an AI module (PERDICT.AI) and home-based diabetes monitoring (PTEC-DM) versus a standalone risk communication session in improving health outcomes (risk perception, medication adherence, self-care activities and glycaemic control) among poorly controlled diabetes patients. Secondary aims are to explore participants' views and experiences of risk communication session using PERDICT.AI, PTEC-DM and usual care and clinician' views on utility of the new approach to improve risk perception.

Methods: A mixed-method study design will be employed to conduct a multi-arm randomized controlled trial across four of the SingHealth Polyclinics cluster (Pasir Ris, Eunos, Sengkang, Tampines North). Patient participants will be randomly allocated in a 1:1:1 ratio to one of the three arms. Arm 1 will receive risk communication session using PERDICT.AI and home-based diabetes monitoring using PTEC-DM alongside usual care. Arm 2 participants will undergo a standalone risk communication session using PERDICT.AI with usual care while arm 3 will serve as the control group with usual care. A total of 360 (120 in each group) participants will be enrolled by simple randomization. Eligible patient must be of age between 36 and 65 years with HbA1c \>8.0% within the last 6 months.

Significance of the study: Findings from the study may add evidence to the scientific knowledge of using these approaches to improve risk perception and recommend development of similar interventions.

Eligibility

Primary outcome measure(s)

• Risk Perception Survey-Diabetes Mellitus (RPS-DM) — through study completion, an average of 12 to 16 months
  The RPS-DM consists of 31 questions. The first section assesses risk knowledge (5 items scored on 3-point scale with 1 point for each correct answer; higher score indicates greater knowledge of the risk of getting diabetes complications). The remaining 26 items comprise 5 subscales which can be described as: perceived personal control (4 items scored on 4-point scale); worry (2 items scored on 4-point scale), optimistic bias (2 items scored on 4-point scale); personal disease risk (9 items scored on a 4-point scale; indicates degree of own perceived risk of getting 9 diseases or conditions, plus additional question about whether they have ever had the condition, scored yes/no with 1 point added for yes response); and environmental risk (9 items scored on a 4-point scale). The composite risk perception is the average of the 26 items in the main questionnaire; higher scores indicate greater comparative perceived risk.
• Health related Quality of life — through study completion, an average of 12 to 16 months
  Change in the scores using EQ-5D-5L questionnaire; The EQ-5D-5L tool comprises five dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. Each dimension has five response levels (no problems, slight problems, moderate problems, severe problems, unable to/ extreme problems). The proportion of patients reporting each level of problem on each dimension of the EQ-5D will be determined through study completion and compared. EQ VAS (Visual Analogue Scale) provides a quantitative measure of the patient's perception of their overall health. The EQ VAS records the respondent's overall current health on a vertical scale (0-100), where the endpoints are labelled '0-The worst health you can imagine' and '100-The best health you can imagine'.
• Medication adherence — through study completion, an average of 12 to 16 months
  Change in the scores using five item Medication Adherence Report Scale (MARS-5); MARS-5 score was calculated by summing the numeric score (range 1-5) from each question for out of 25 (range 5-25). A higher score indicates better adherence.
• Summary of Diabetes Self-care Activities (SDSCA) questionnaire — through study completion, an average of 12 to 16 months
  SDSCA questionnaire collects data on general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking, using an 8-point Likert-type scale (0-7), which represents the number of days per week when the given self-care activity was performed. Scores are calculated separately for each item and the level of adherence is indicated by the mean score for each dimension.
• Iowa-Netherlands Comparison Orientation Measure (INCOM) — baseline enrolment
  The INCOM is an 11-item measure of one's tendency to make social comparisons. The scale includes such items as: "I always like to know what others in a similar situation would do." Response choices range from 1 (disagree strongly) to 5 (agree strongly). Higher scores indicate more of a tendency to socially compare.

Trial sites (1)

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