CrOss-cultural Model for Postdischarge Assistance and Sustainable Digital Solutions in Phase III Cardiac Rehabilitation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 11
- 主要终点
- 6-month change in composite Life's Essential 9 (LE9)
研究概览
简要总结
Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention & Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LC9) (LE8 + PHQ-9).
详细描述
Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention & Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LE9) (LE8 + PHQ-9). Intervention (DEEPER) will include informative modules (patient will choose among graphic medicine, video or interactive messaging) that will be delivered every two weeks via secure digital platform (or booklet if offline); monthly motivational messages; moderated peer-support forum with leaderboard; remote wearable step/sleep upload with personalized content assignment and feedback, linked to the hospital interactive digital platform (Rehab companion).
Patients will be encouraged to have their own device to be adopted as lifelong maintenance. Nevertheless, centres will provide a smartwatch (fitbit) to all the patients enrolled in the trial as incentive for study participation and to uniformly collect study outcomes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18, men and women;
- •patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure);
- •patients who completed phase II CR and are therefore eligible for CR phase III (maintenance).
排除标准
- •Unable to sign the informed consent;
- •unable or unwilling to use digital devices due to mental/cognitive issues or without a support person helping them to access the respective technical devices;
- •pregnant, lactating or women planning pregnancy during the course of the trial.
研究组 & 干预措施
DEEPER
As "Standard Care" plus every 15 days in the first month and at least once a month chat with healthcare professional that will keep posted with the patient and the staff (nurse, physiotherapist, cardiologist) for all the issues raised by the patients. chat with answer within 72 hours. Graphical medicine to increase patients' awareness.
干预措施: DEEPER (Behavioral)
Standard of care
Discharge after phase II, LC9 evaluation, discharge indications, website indication for every country language support (from the European Society of Preventive Cardiology). FU contact by phone at 3 months, clinical visit at 6 months [6 month LE9 assessment (primary endpoint)] and contact by phone at 1 year for MACE evaluation.
结局指标
主要结局
6-month change in composite Life's Essential 9 (LE9)
时间窗: 6-month change
LC9 is defined by the American Heart Association's Life's Essential 8 (LE8), complemented by the Patient Health Questionnaire (PHQ-9), collectively referred to as "LC9 \[blood pressure, non-high-density lipoprotein cholesterol (HDL), diet questionnaire, physical activity, smoking habits, sleep health, body mass index (BMI), hemoglobin A1c (HbA1c, %), PHQ9 from questionnaire).
6-month change in composite Life's Essential 9 (LE9)
时间窗: 6-month change
LE9 is defined by the American Heart Association's Life's Essential 8 (LE8), complemented by the Patient Health Questionnaire (PHQ-9), collectively referred to as "LE9 \[blood pressure from home measurements, non-high-density lipoprotein cholesterol (HDL) from general practitioner (GP), Mediterranean Eating Pattern for Americans (MEPA) diet questionnaire, physical activity from device, smoking habits from questionnaire, sleep health from device, body mass index (BMI) from home measurement, fasting blood glucose (FBG in mg/dL) and hemoglobin A1c (HbA1c, %) from GP, PHQ9 from questionnaire).
次要结局
- Economic impact of the CR pathways and financial sustainability: standard care versus stardard care plus the DEEPER package(6 months)
- Acceptance of the usual care and the DEEPER package pathway using the Service User Technology Acceptance Questionnaire (SUTAQ) average values(6 months)
- Assessment of social, ethical and equity dimensions.(6 months)
- Social costs(6 months)
- Individual LE8 sub-scores(6-month change)
- GAD 7(Changes between baseline and 6-month follow-up)
- PHQ 9(Changes between baseline and 6-month follow-up)
- Physical fitness(Changes between baseline and 6-month follow-up)
- VO2 peak(Changes between baseline and 6-month follow-up)
- 30 second sit-to -stand test(Changes between baseline and 6-month follow-up)
- Hand-grip strength(Changes between baseline and 6-month follow-up)
- Steps per day(Changes between baseline and 6-month follow-up)
- Waist circumference(Changes between baseline and 6-month follow-up)
- counter movement jump test.(Changes between baseline and 6-month follow-up)
- Compliance with study treatment(6 months)
- Individual LE8 sub-scores(6-month change)
- Major adverse cardiovascular event (MACE)(1 year)
- GAD 7(Changes between baseline and 6-month follow-up)
- PHQ 9(Changes between baseline and 6-month follow-up)
- Physical fitness(Changes between baseline and 6-month follow-up)
- VO2 peak(Changes between baseline and 6-month follow-up)
- 30 second sit-to -stand test(Changes between baseline and 6-month follow-up)
- Hand-grip strength(Changes between baseline and 6-month follow-up)
- Steps per day(Changes between baseline and 6-month follow-up)
- Waist circumference(Changes between baseline and 6-month follow-up)
- counter movement jump test.(Changes between baseline and 6-month follow-up)
- Compliance with study treatment(6 months)
- Economic impact of the CR pathways and financial sustainability: standard care versus stardard care plus the DEEPER package(6 months)
- Acceptance of the usual care and the DEEPER package pathway using the Service User Technology Acceptance Questionnaire (SUTAQ) average values(6 months)
- Assessment of social, ethical and equity dimensions.(6 months)
- Social costs(6 months)
- Safety endpoint(6 months)
- Major adverse cardiovascular event (MACE)(6 months)