Effectiveness and implementation of an embedded community-based heart-age risk education model (E-CHARM) in improving cardiovascular risk awareness and health behaviors among older adults with hypertension: Protocol for a randomized controlled trial.

The trial is designed as a parallel-group, individually randomized controlled trial embedded within routine chronic disease management at a community health center in Kunshan, China.

• The study uses a 1:1 randomization allocation
• Approximately 400 adults will be enrolled
• Participants must be aged 60 years and above with hypertension
• The trial is registered as NCT07045363
• The setting is a community health center in Kunshan, China

The intervention consists of a personalized Heart Age report delivered with a brief physician explanation, compared to usual care.

• The experimental arm receives a personalized Heart Age report with brief physician explanation
• The control arm receives usual care
• The intervention is embedded within existing primary care workflows
• The model is described as the 'embedded community-based heart-age risk education model (E-CHARM)'
• The intervention is designed to avoid increasing resource burden

The primary outcome of CVD risk awareness is measured at 3 months post-intervention.

• CVD risk awareness at 3 months is the designated primary outcome
• Secondary outcomes include changes in self-reported physical activity, diet, and medication adherence
• An exploratory analysis of clinical indicators (blood pressure, glucose, lipids, BMI) will be conducted at 12 months
• Implementation outcomes including feasibility, acceptability, and fidelity will also be assessed

The study is motivated by the finding that despite comprehensive primary care-based chronic disease management, patients' awareness of CVD risk and motivation for self-management remain suboptimal.

• Cardiovascular disease is described as the leading cause of mortality in China
• Hypertension is identified as the most common modifiable risk factor for CVD
• Current chronic disease management is described as comprehensive but insufficient for improving patient awareness and self-management motivation
• The trial is described as 'pragmatic' in design

The trial aims to assess whether personalized risk communication can be feasibly scaled within low-resource primary care settings.

• Findings are intended to 'inform the feasibility and scalability of personalized risk communication strategies in low-resource primary care settings'
• The intervention is designed to be delivered without increasing resource burden
• Implementation outcomes (feasibility, acceptability, fidelity) are explicitly included as study outcomes
• The model integrates brief, physician-delivered risk feedback within existing primary care workflows