A Health Coach-Led Digital Lifestyle Intervention (HEALDI) for the Regression of Diffuse Myocardial Fibrosis: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Regression of diffuse myocardial fibrosis
研究概览
简要总结
Aim: To evaluate the effectiveness of an artificial intelligence (AI)-assisted 12-month Health Coach-Led Digital Lifestyle Intervention (HEALDI) versus control on diffuse myocardial fibrosis and ambulatory blood pressure in individuals with hypertensive heart disease (HHD), with secondary outcomes including multi-organ health parameters, health behaviours, social support, psychological health, and health-related quality of life.
Background: The global prevalence of hypertensive heart disease (HHD) has increased approximately 1.5-fold, from 7.82 million cases in 1990 to 12.50 million in 2021, and it is now the second leading cause of heart failure worldwide. In HHD, chronic pressure overload drives fibroblast activation and interstitial collagen deposition, leading to diffuse myocardial fibrosis which is associated with cardiac dysfunction, arrhythmias, impaired coronary flow reserve, and an increased risk of sudden cardiac death and heart failure. Although diffuse myocardial fibrosis is potentially reversible, no approved anti-fibrotic pharmacological therapy currently exists. Furthermore, there is limited evidence evaluating the effectiveness of lifestyle interventions, particularly aerobic exercise, in reversing diffuse myocardial fibrosis.
Design: A parallel, single-blinded two-arm randomised controlled trial.
Method: This study is a randomised controlled trial with repeated measures, recruiting 200 physically inactive individuals with HHD from the community, including participants from Project RESET, a community-based cohort study in Singapore. Participants will be randomly allocated to either the intervention or control group.
Participants in the intervention group will receive the 12-month HEALDI intervention, which includes the HEALDI mobile application, wearable device, and remote health coaching. Participants in the control group will receive a wearable device and a basic mobile application without intervention features, used solely for data collection.
Data will be collected at baseline (upon randomisation) and at 6, 12 and 24 months. A process evaluation will be conducted using intervention engagement data. In addition, semi-structured interviews with participants and health coaches will explore perceptions of the intervention and behaviour change. A within-trial economic evaluation, from both healthcare system and societal perspectives, will be performed to assess cost-effectiveness.
Significance: This study will generate insights into the role of lifestyle modification as a complementary, non-pharmacological strategy alongside pharmacotherapy to halt or slow HHD progression, improving long-term cardiovascular outcomes.
详细描述
Specific Study Aims
- To compare the effectiveness of HEALDI on change in diffuse myocardial fibrosis, ambulatory blood pressure, with secondary outcomes including multi-organ clinical parameters (e.g. blood tests, liver and brain imaging) and patient-reported outcomes (e.g. physical activity, dietary practices, perceived stress, sleep quality, medication adherence, social support, psychological health, and health-related quality of life).
- Examine the cost-effectiveness of HEALDI intervention.
- Explore the perceptions of the individuals with HHD and health coaches regarding HEALDI.
Hypotheses
It is hypothesised that participants who received the HEALDI intervention, compared to the control group will have:
- Greater regression in diffuse myocardial fibrosis;
- Greater improvement in ambulatory blood pressure;
- Improved multi-organ clinical paramaters;
- Greater adoption and sustained adherence to health behaviours;
- Better quality of life;
- Lower cost to participants and hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigator will remain blinded to group allocation. Outcome assessors, including research assistants administering questionnaires and technicians performing study procedures, will be blinded to participants' assigned groups.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left ventricular hypertrophy on cardiovascular magnetic resonance based on local age and sex specific criteria
- •Age 40-70 years old
- •Has internet access
- •Owns and uses a smartphone daily
- •Able to converse and comprehend the English or Chinese language
排除标准
- •History of major cardiovascular events (MACE), which is defined as coronary heart disease death, non-fatal myocardial infarction, stroke
- •Diagnosed with secondary causes of hypertension (E.g., renal causes - renal artery stenosis, chronic renal failure; endocrine causes- pheochromocytoma, Cushing's syndrome, hyperthyroidism; cardiac causes - coarctation of the aorta)
- •Diagnosed with significant coronary artery disease with previous percutaneous intervention or coronary artery bypass surgeries
- •Diagnosed with cardiac arrhythmias such as atrial fibrillation and frequent premature ventricular contractions
- •Diagnosed with inherited/acquired cardiomyopathies (E.g., hypertrophic cardiomyopathy, dilated cardiomyopathy)
- •Diagnosed with infiltrative disease (E.g., cardiac amyloid, cardiac sarcoid)
- •Contraindications to Brain and Cardiac Magnetic Resonance or gadolinium contrast (E.g., renal failure- eGFR <30ml/min/m2 or documented contrast allergy; implantable devices such as cardiac pacemakers, brain aneurysms or clips, metal implants (including braces), foreign bodies in the eye; claustrophobia; end organ failure; women who are pregnant or breast-feeding)
- •Any pre-existing medical conditions or disabilities that limits their participation in lifestyle interventions (E.g., Dementia)
- •Individuals who have achieved the Singapore physical activity guideline of 150 minutes of moderate intensity exercise or 75 minutes of vigorous intensity exercise per week or an equivalent combination per week
- •Limited life expectancy of less than 12 months
- •Participating in other research projects involving behavioural therapy or changes related to physical activity
研究组 & 干预措施
HEALDI Intervention Group
A 12-month, AI-assisted, health coach-led digital lifestyle intervention where participants will receive a wearable, HEALDI mobile app and remote health coaching sessions.
干预措施: HEALDI Intervention (Other)
Control Group
Participants will receive a wearable and basic mobile app without intervention features, used solely for data collection.
结局指标
主要结局
Regression of diffuse myocardial fibrosis
时间窗: Baseline and 12 months upon randomisation
Change in indexed interstitial volume assessed by cardiovascular magnetic resonance
次要结局
- Blood pressure(Baseline and 12 months upon randomisation)
- Left ventricular function(Baseline and 12 months upon randomisation.)
- Left ventricular mass(Baseline and 12 months upon randomisation.)
- Left ventricular volume(Baseline and 12 months upon randomisation.)
- Diastolic and systolic function(Baseline and 12 months (upon randomisation))
- Valvular function(Baseline and 12 months (upon randomisation).)
- Heart function(Baseline and 12 months upon randomisation)
- First occurrence of cardiovascular event(2 years)
- Markers of liver fat, inflammation and stiffness(Baseline, 12 months and 24 months upon randomisation)
- Markers of liver fat, inflammation and stiffness(Baseline and 12 months upon randomisation.)
- Brain structure(Baseline, 12 months and 24 months upon randomisation.)
- Cognitive function(Baseline and 12 months upon randomisation.)
- Cardiac and inflammatory markers(Baseline, 12 months and 24 months)
- Circulating biomarkers of inflammation and fibrosis(Baseline and 12 months upon randomisation.)
- Liver function tests(Baseline, 12 months and 24 months from randomisation)
- Lipid profile(Baseline, 12 months and 24 months upon randomisation)
- Renal function markers(Baseline, 12 months and 24 months from randomisation)
- Glycemic control(Baseline, 12 months and 24 months upon randomisation.)
- Body Mass Index(Baseline, 12 months and 24 months upon randomisation.)
- Body composition: Body fat(Baseline and 12 months upon randomisation.)
- Body composition: Muscle Mass(Baseline and 12 months upon randomisation.)
- Body composition: Total body water(Baseline and 12 months upon randomisation.)
- Waist Circumference(Baseline, 12 months and 24 months upon randomisation.)
- Energy expenditure(Baseline and 12 months upon randomisation.)
- Depressive symptoms(Baseline, 6 months, 12 months and 24 months upon enrolment.)
- Anxiety symptoms(Baseline, 6 months, 12 months and 24 months upon enrolment.)
- Health Behaviour: Physical Activity (Wearable)(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health Behaviour: Physical Activity (IPAQ-SF)(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health Behaviour: Physical Activity (MPAM-R)(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health Behaviour: Physical Activity (Stage of Change for Physical Activity Questionnaire)(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health Behaviour: Sleep Quality and Duration(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health Behaviour: Sleep (Wearable)(Baseline, 6 months, 12 months and 24 months upon randomisation)
- Health Behaviour: Perceived Stress(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health Behaviour: Social Support(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health Behaviour: Medication Adherence(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health Behaviour: Dietary Behaviour(Baseline, 6 months, 12 months and 24 months upon randomisation.)
- Health-related quality of life(Baseline, 6 months, 12 months, 24 months from enrolment.)
- Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI)(6 months, 12 months and 24 months upon randomisation.)
- Cost-Effectiveness Analysis (CEA)(6 months, 12 months and 24 months upon randomisation.)
研究者
Wang Wenru
Professor
National University of Singapore