An interventional study of Personalised Digital Behavioural Nudges (NADI-MyHeartRisk Enhanced Pathway) in Cardiovascular Diseases and Cardiovascular Risk Factor, sponsored by Cardiovascular Advancement and Research Excellence Institute. Not yet recruiting at 2 sites in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Cardiovascular Advancement and Research Excellence Institute · Not applicable, Interventional, and Prevention
This is a pragmatic, risk-stratified, individually randomized controlled trial testing whether personalised WhatsApp-based digital behavioural nudges can improve completion of cardiovascular preventive actions after community risk screening at NADI centres in Malaysia.
Adults attending participating NADI centres will be screened using the MyHeartRisk web-based cardiovascular risk assessment tool. All screened participants will receive their risk result, standard risk explanation and general heart-health education. Participants classified as high cardiovascular risk will also receive a referral letter advising healthcare provider review.
Participants classified as moderate or high cardiovascular risk will be randomized 1:1 to either a personalised digital nudge arm or a no-nudge control arm. The nudge arm will receive scheduled WhatsApp messages over 90 days, including action prompts, reminders, engagement check-ins and barrier-solving messages. The control arm will receive standard risk feedback and referral-letter generation where indicated, but no scheduled behavioural nudges.
The primary outcome is completion of a risk-appropriate cardiovascular preventive action within 90 days. For moderate-risk participants, this may include completion of blood pressure, glucose or lipid checks, medication review, or healthcare provider review. For high-risk participants, this is attendance at a healthcare provider after receiving the MyHeartRisk referral letter. Low-risk participants will receive standard feedback and may be followed descriptively, but they will not be randomized or included in the primary randomized analysis.
Cardiovascular disease remains a major cause of preventable morbidity and mortality. Community-based cardiovascular risk screening can identify individuals at increased risk, but risk awareness alone may not lead to preventive action. This study evaluates whether a personalised digital behavioural-nudge pathway delivered after MyHeartRisk community screening can improve completion of risk-appropriate cardiovascular preventive actions within 90 days.
This is a pragmatic, risk-stratified, individually randomized, 2-group parallel controlled trial nested within routine NADI centre operations across Malaysia. Adults attending participating NADI centres will undergo MyHeartRisk cardiovascular risk screening. MyHeartRisk is a web-based cardiovascular risk assessment and risk communication platform used by trained NADI staff. Participants will be classified as low, moderate/intermediate, or high cardiovascular risk using the Framingham Risk Score-based trial classification.
All screened participants will receive their MyHeartRisk result, standard risk explanation and general heart-health education. Participants classified as high cardiovascular risk will also receive a MyHeartRisk referral letter advising healthcare provider review. Participants classified as low cardiovascular risk will not be randomized and will not contribute to the primary randomized effectiveness analysis. They may be followed descriptively as part of the implementation cohort.
Participants classified as moderate/intermediate or high cardiovascular risk will be randomized after risk classification and standard baseline risk feedback. Randomization will be performed centrally by the MyHeartRisk platform using a computer-generated allocation sequence. Allocation will be 1:1 between the personalised digital nudge arm and the no-nudge control arm. Randomization will be stratified by risk category and, where technically feasible, by NADI centre or region. If centre-level stratification is not feasible because of small numbers per centre, randomization will be stratified by risk category, with NADI centre included as a random effect in the analysis.
The target enrollment for the randomized trial component is 848 moderate/intermediate- or high-risk participants, allocated 1:1 to the personalised digital nudge arm and the no-nudge control arm. This enrollment target refers to the randomized trial population, not the wider NADI screening cohort. The wider NADI programme provides the operational screening pool from which eligible participants are identified. Across 1,098 NADI centres, the minimum operational target is one participant per centre per month over six months, giving 6,588 screened participants. Where feasible, centres may screen up to two participants per month, giving a stretch operational target of 13,176 screened participants. Low-risk participants may be followed descriptively but will not be included in the primary randomized analysis.
Participants in the personalised digital nudge arm will receive standard baseline care plus automated, risk-specific WhatsApp messages over 90 days. The intervention is grounded in the Behaviour Change Wheel and COM-B model. Messages are designed to support psychological capability through clear risk explanation and actionable next steps, opportunity through scheduled prompts and referral support, and motivation through engagement check-ins, reminders, action-planning prompts and barrier-solving messages. Active nudge contacts are scheduled in four structured cycles at Day 3, Day 5, Day 7, Day 14, Day 16, Day 18, Day 45, Day 47, Day 49, Day 60, Day 62, and Day 64.
Participants in the no-nudge control arm will receive standard baseline care only. This includes MyHeartRisk risk feedback, standard risk explanation, general heart-health education and referral letter generation for high-risk participants. They will not receive scheduled behavioural nudges, personalised prompts, action-planning messages, reminder messages or barrier-check messages during the 90-day follow-up period. No clinically indicated advice, referral or follow-up normally available outside the study is withheld from any participant in either arm, and participants may seek care at any time.
Both arms will receive neutral, standardized outcome-assessment messages at Day 30 and Day 90. These assessment messages are used for data collection only and will not contain behavioural advice, referral reminders, encouragement or personalised prompts. This is intended to reduce measurement bias and preserve the no-nudge comparison.
The primary outcome is completion of a prespecified, risk-appropriate cardiovascular preventive action within 90 days among randomized moderate/intermediate- and high-risk participants. For moderate/intermediate-risk participants, this includes completion of cardiovascular preventive health checks, such as blood pressure, glucose or lipid assessment, medication review, or healthcare provider review. For high-risk participants, this is attendance at a healthcare provider within 90 days after MyHeartRisk screening and referral letter generation. Only actions that take place after the MyHeartRisk screening visit count; measurements taken at the screening visit itself are excluded.
Outcome completion will be assessed using a pragmatic verification hierarchy that includes documentary evidence, healthcare provider or study-staff confirmation, participant self-report with supporting details, and participant self-report without supporting details. Submitting documentary evidence is optional, only the date, facility and action type are recorded, and declining does not affect participation. The primary analysis will follow the intention-to-treat principle and will use mixed-effects regression models accounting for centre-level clustering.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 6,588 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
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Participants classified as high risk without calculation of an FRS, within the high-risk stratum:
Exclusion Criteria:
Participants in this arm will receive standard MyHeartRisk baseline care plus personalised WhatsApp-based digital behavioural nudges over 90 days. Standard baseline care includes MyHeartRisk risk feedback, standard risk explanation, general heart-health education and, for high-risk participants, a MyHeartRisk referral letter advising healthcare provider review. The personalised nudge intervention includes automated, risk-specific action prompts, reminders, engagement check-ins, action-planning prompts and barrier-solving messages. Active nudge contacts are scheduled in four structured cycles at Day 3, Day 5, Day 7; Day 14, Day 16, Day 18; Day 30, Day 45, Day 47, Day 49, Day 60, Day 62, Day 64 and Day 90. Neutral outcome-assessment messages are sent at Day 30 and Day 90; these are not nudge contacts.
Behavioral: Personalised Digital Behavioural Nudges (NADI-MyHeartRisk Enhanced Pathway)
Participants in this arm will receive standard MyHeartRisk baseline care only. Standard baseline care includes MyHeartRisk risk feedback, standard risk explanation, general heart-health education and, for high-risk participants, a MyHeartRisk referral letter advising healthcare provider review. Participants in the no-nudge control arm will not receive scheduled behavioural nudges, personalised prompts, action-planning messages, reminder messages or barrier-check messages during the 90-day follow-up period. Neutral outcome-assessment messages will be sent at Day 30 and Day 90 for data collection only. These messages will be identical in purpose to those sent to the personalised digital nudge arm and will not contain behavioural advice, referral reminders, encouragement or personalised prompts. Control participants are not deprived of any clinically indicated advice, referral or follow-up, and may seek care at any time.
A WhatsApp-delivered sequence of personalised, risk-stratified behavioural messages (action prompts, reminders, barrier-solving and engagement check-ins) developed using the Behaviour Change Wheel and COM-B model, delivered over 90 days following cardiovascular risk screening.
Number of Participants Completing a Risk-Appropriate Cardiovascular Preventive Action by Day 90
This is a single binary participant-level outcome (completed/not completed). Unit of measure: number of participants. No clinical measurement values are analysed, only completion of a qualifying healthcare-linked action is recorded. A participant is counted once if ≥1 qualifying action occurs within 90 days of screening, otherwise, they are not completed. Moderate-risk actions include BP, glucose/HbA1c or lipid assessment, cardiovascular prevention review, or medication review by a healthcare provider. High-risk completion requires attendance for cardiovascular risk assessment or follow-up after referral-letter generation. Both strata are combined into one outcome; baseline risk stratum is a covariate, not a separate outcome. Completion is verified through documentary evidence (Level 1), provider/clinic/staff confirmation (Level 2), or self-report with supporting details (Level 3). Level 4 self-report without supporting details. The primary analysis counts Levels 1 to 3 as completed.
Time frame: Within 90 days after MyHeartRisk screening
Referral completion among high-risk participants
Referral completion is defined as attendance at an eligible healthcare provider within 90 days of MyHeartRisk screening and referral-letter generation for cardiovascular risk assessment or follow-up. Medication initiation or a new diagnosis is not required for completion.
Time frame: Within 90 days after MyHeartRisk screening
Preventive health-check completion among moderate-risk participants
This is a single binary participant-level outcome (completed/not completed). Unit of measure: number of participants. Unit of measure: number of participants. No clinical measurement values are analysed for this outcome. Blood pressure, blood glucose, HbA1c and lipid results are not reported as values; only whether a qualifying healthcare-linked action took place. A participant is counted as completed if at least one qualifying action occurred within 90 days of MyHeartRisk screening, and as not completed if none occurred. Where a participant completes more than one qualifying action, the participant is counted once. Qualifying actions are defined by the participant's baseline risk stratum. Moderate risk: at least one of blood pressure assessment, blood glucose assessment (fasting, random, or HbA1c), lipid assessment, healthcare provider review for cardiovascular risk assessment or prevention, or medication review by a healthcare provider for a cardiovascular risk-related indication.
Time frame: Within 90 days after MyHeartRisk screening
Completion of the primary outcome by Day 30
Day-30 primary-outcome completion is defined using the same prespecified risk-appropriate criteria as the primary outcome, but assessed by Day 30, at least one qualifying preventive action for moderate-risk participants or healthcare-provider review after referral for high-risk participants. Completion is classified as yes/no based on the action occurring within 30 days of screening.
Time frame: Within 30 days after MyHeartRisk screening
Time from screening to first completed risk-appropriate preventive action
Time to action is the number of days from the MyHeartRisk screening date to the participant's first completed qualifying risk-appropriate preventive action. Where more than one qualifying action occurs, only the first is used for this time-to-action measure.
Time frame: Up to 90 days after MyHeartRisk screening
Appointment booking rate by Day 30
Percentage of randomised participants who booked an appointment for the relevant healthcare review or preventive action by Day 30, regardless of whether the appointment has been attended. Unit of measure: percentage of participants.
Time frame: Within 30 days after MyHeartRisk screening
Appointment booking rate by Day 90
Percentage of randomised participants who booked an appointment for the relevant healthcare review or preventive action by Day 90, regardless of whether the appointment has been attended. An appointment scheduled after Day 90 is recorded as a booking but does not count as Day-90 action completion. Unit of measure: percentage of participants
Time frame: Within 90 days after MyHeartRisk screening
Nudge message delivery rate
Percentage of scheduled nudge messages successfully delivered to participants in the personalised digital nudge arm, derived from messaging-platform delivery records. Denominator: all scheduled nudge messages. Unit of measure: percentage of messages.
Time frame: Day 3 to Day 64 (active nudge period)
Nudge message read rate
Percentage of delivered nudge messages recorded by the messaging platform as opened or read. Denominator: all delivered nudge messages. Unit of measure: percentage of messages.
Time frame: Day 3 to Day 64 (active nudge period)
Nudge message reply rate
Percentage of delivered nudge messages that prompted a participant reply. Denominator: all delivered nudge messages. Unit of measure: percentage of messages.
Time frame: Day 3 to Day 64 (active nudge period)
Nudge message click-through rate
Percentage of delivered nudge messages containing a link in which the link was selected by the participant. Denominator: delivered nudge messages containing a link. Unit of measure: percentage of messages.
Time frame: Day 3 to Day 64 (active nudge period)
Nudge message opt-out rate
Percentage of participants in the personalised digital nudge arm who opted out of nudge messages by replying STOP or using another approved opt-out mechanism. Denominator: participants randomised to the nudge arm. Unit of measure: percentage of participants.
Time frame: Within 90 days after MyHeartRisk screening
Participant-reported barriers to action
Participant-reported barriers are reasons identified by participants for not completing or delaying the recommended preventive action, such as uncertainty about where to go, lack of time, transport difficulties, worry, or other reported obstacles. Barriers are captured through follow-up assessment and nudge barrier-check responses.
Time frame: At Day 30 and Day 90 assessment
Participant-reported satisfaction with the programme
Participant-reported rating of how helpful the NADI-MyHeartRisk programme and messages were, collected in the Day 90 final assessment as a single categorical item with response options Helpful, Neutral, or Not Helpful. Unit of measure: number of participants in each response category.
Time frame: At Day 90
System Usability Scale score
Perceived usability of the NADI-MyHeartRisk digital pathway, measured using the System Usability Scale. The System Usability Scale (SUS) is a 10-item questionnaire, item responses are summed and transformed to a total score ranging from 0 to 100. Higher scores indicate better perceived usability, 0 is the worst possible score and 100 the best. Unit of measure: units on a scale.
Time frame: At Day 90
Self-reported lifestyle action
Number of participants reporting adoption of at least one recommended healthy lifestyle behaviour, including increased physical activity, healthier dietary practices, improved sleep, increased hydration, weight-management activity, or smoking cessation, by Day 90. Reported as a single binary composite. Unit of measure: number of participants.
Time frame: By Day 90
Medication review, initiation, or adjustment after healthcare provider review
Number of participants with at least one medication-related action, including medication review, initiation of a new medication, or adjustment of an existing medication, occurring after the MyHeartRisk screening date and linked to a healthcare-provider review. Medication changes are counted only when associated with provider review rather than self-directed medication use. Unit of measure: number of participants.
Time frame: Within 90 days after MyHeartRisk screening
Safety escalation, including red-flag symptom reporting or urgent-care advice
Safety escalation is defined as a reported red-flag symptom or other safety event that triggers urgent-care advice or study escalation, including inappropriate message delivery, complaints, or relevant protocol/safety events. Red flags include symptoms such as chest pain, severe breathlessness, fainting/collapse, sudden weakness, facial droop, slurred speech, or severe palpitations with dizziness.
Time frame: Continuously over the 90-day study period
Plan to share: No
Start is estimated for Oct 2026; primary completion for Jul 2027, 8 months later.
Of 1,032 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 8 months is below that.
Counting every sponsor, half of 1,148 studies reached it within 26 months; a quarter within 13 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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