Preventing Ischemic Heart Disease With mHealth, Electronic Decision Support, and Community Health Workers (PRIMECare Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 968
- 试验地点
- 1
- 主要终点
- Difference in mean change in absolute CVD risk, calculated using the Framingham cardiovascular disease lab-based risk equation, between study arms at 12 months
研究概览
简要总结
This is a cluster-randomized clinical trial (cRCT) designed to assess the effectiveness of a multicomponent strategy linking key aspects of the cardiovascular disease (CVD) care continuum across three provinces in Argentina using using five primary components: a data management system linking a digital mHealth (mobile health) screening tool used by community health workers (CHWs), an electronic appointment scheduler which is integrated with the clinic electronic appointment system, point of care (POCT) testing for lipids, a clinical decision support system for medication initiation, and a text message (SMS) reminder system to improve treatment adherence and life-style changes.
详细描述
954 eligible women and men aged 40-74 with high CVD risk living in the catchment area of 18 primary care clinics (PCCs) in 3 different provinces (Quilmes, La Rioja, and San Juan) in Argentina will be recruited for the study. Eighteen PCCs will be randomized to either the usual care (control) arm or the intervention arm (3 usual care and 3 intervention PCCs in each province). Participants who reside in the catchment area of intervention PCCs will receive the multicomponent intervention with central data management system linking digital mHealth (mobile health) screening tool for CHWs, electronic appointment scheduling which is integrated with the clinic electronic appointment system, point of care testing (POCT) for lipids, clinical decision support for medication initiation, and a SMS reminder system for adherence to medications and life-style changes, while participants who reside in the catchment area of usual care PCCs will receive usual care with paper-based guidelines used by community health workers and providers. The recruitment goals are 477 persons in the intervention arm and 477 in the usual care arm. Participants will be enrolled for a 12 month study period from baseline visit, and the primary outcome is mean difference in absolute 10-year CVD risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 40-74
- •depend exclusively on public health insurance
- •have access to a cell phone for personal use
- •can open and read SMS messages on cell phone
- •receive primary care at the local PCC
- •have a 10-year CVD risk >= 10% and mean SBP >= 140 mmHg OR
- •have a 10-year CVD risk >= 10% and LDL-C >= 70 mg/dL for persons with diabetes OR
- •have a 10-year CVD risk >= 10% and LDL-C >= 100 mg/dL for persons without diabetes
排除标准
- •Persons who plan to move from the neighborhood within the next 2 years
- •pregnant at the time of screening
- •Bed bound
- •Weight > 180 kg - this exceeds the upper limit that can be measured on portable scales.
- •Total cholesterol < 100 mg/dL or > 500 mg/dL.
- •LDL-C > 300 mg/dL
- •Triglycerides < 45 mg/dL or > 400 mg/dL.
- •HDL < 15 mg/dL.
- •Systolic blood pressure (SBP) >=180 mmHg or Diastolic blood pressure (DBP) >= 120 mmHg, and experiencing chest pain, palpitations, or shortness of breath.
- •currently on dialysis or has a history of chronic kidney disease.
- •self-reported history of CVD (stroke, AMI).
- •self-reported history of a liver abnormality.
- •have a mid-upper arm circumference > 42 cm - this is the maximum cuff size available for use with blood pressure monitors in Argentina
- •do not consent to participate.
研究组 & 干预措施
Usual Care
with paper-based guidelines used by community health workers (CHW) and providers
干预措施: Usual Care Model (Behavioral)
Intervention
with central data management system linking digital mHealth screening tool for CHWs, electronic appointment scheduling, point of care testing (POCT) for lipids, clinical decision support for medication initiation, and a SMS reminder system for adherence to medications and life-style changes
干预措施: CHW Care Model (Behavioral)
结局指标
主要结局
Difference in mean change in absolute CVD risk, calculated using the Framingham cardiovascular disease lab-based risk equation, between study arms at 12 months
时间窗: At enrollment (baseline) and 12 months after enrollment
The difference in mean change in 10-year CVD risk between study arms
次要结局
- Medical costs incurred over 12-month study period(From enrollment to end of the study period at 12 months)
- Difference in mean change in LDL-C between study arms at 12 months(At enrollment (baseline) and 12 months after enrollment)
- Quality adjusted life years (QALYs)(From enrollment to end of the study period at 12 months)
- Proportion of patients with a 10-year CVD risk ≥ 10% that complete a first visit at the local clinic within 6 weeks after enrollment in the study.(6 weeks from enrollment.)
- Difference in mean change in systolic blood pressure between study arms at 12 months(At enrollment (baseline) and 12 months after enrollment)
- Changes in smoking rates over 12-month study period(At enrollment (baseline) and 12 months after enrollment)
- Mortality(From the start of enrollment to 12, then 60 months after enrollment)
- Medication possession ratios at 12 months between study arms(At 12 months after enrollment)
- Medication intensity changes(From enrollment to end of the study period at 12 months)
- Proportion of patients with a 10-year CVD risk ≥ 10% that complete a first visit at the local clinic within 4 months after enrollment in the study.(4 months from enrollment)
- Number of clinical visits between study arms at 12 months(From enrollment to end of the study period at 12 months)
- Major adverse reactions for statins and anti-hypertension medications(From enrollment to end of the study period at 12 months)
- Health utilization outcomes(From enrollment to end of the study period at 12 months)
研究者
Thomas Gaziano
Associate Professor
Harvard School of Public Health (HSPH)