Addressing Hypertension Care in Africa (ADHINCRA) Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800
- 试验地点
- 33
- 主要终点
- Number of participants with systolic blood pressure <140 mmHg
研究概览
简要总结
The ADHINCRA Program is a bundle of multilevel evidence-based interventions that address multiple predictors of controlled hypertension, including patient-, provider-, and health system-level factors. The successful implementation of the ADHINCRA program will provide a rigorous and scalable model for improving hypertension control in Africa, which would ultimately reduce the risk of cardiovascular disease, stroke and kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 -70 years.
- •Diagnosis of hypertension and elevated systolic blood pressure measure (≥140 mmHg) on the most recent clinic visit (within the previous 6 months) without a diabetes diagnosis.
- •Receives primary care at one of the participating sites.
- •Willing and able to provide informed consent in English, Twi, Dagbani, Ewe or Yoruba.
- •Owns a smartphone (Android or iOS).
排除标准
- •Age <18 years or >70 years.
- •Severely elevated BP (≥180/110mmHg).
- •Diagnosis of stroke, coronary artery disease, or kidney disease.
- •Diagnosis of end-stage renal disease (ESRD) treated with dialysis.
- •Serious medical condition which either limits life expectancy or requires active management (e.g., cancer).
- •Cognitive impairment or other conditions preventing study participation
- •Pregnant or currently nursing a child
- •Unwilling to provide informed consent
研究组 & 干预措施
Cohort 1
This cohort will be the first to participate in the ADHINCRA Program, which includes home blood pressure monitoring, an mHealth app, nurse-led lifestyle counselling and treatment with a simplified hypertension control protocol.
干预措施: ADHINCRA Program (Behavioral)
Cohort 2
This cohort will begin the ADHINCRA Program 3 months after Cohort 1.
干预措施: ADHINCRA Program (Behavioral)
Cohort 3
This cohort will begin the ADHINCRA Program 6 months after Cohort 1.
干预措施: ADHINCRA Program (Behavioral)
Cohort 4
This cohort will begin the ADHINCRA Program 9 months after Cohort 1.
干预措施: ADHINCRA Program (Behavioral)
结局指标
主要结局
Number of participants with systolic blood pressure <140 mmHg
时间窗: Baseline and 12 months post-randomization
Blood pressure control among participants defined as systolic blood pressure \<140 mmHg
次要结局
- Number of participants with diastolic blood pressure <90 mmHg(Baseline, 12 months, 24 months post-randomization)
- Medication adherence as assessed by Hill-Bone Medication Adherence Scale(Baseline, 12 months, 24 months post-randomization)
- Percentage of sites that adopt and maintain the intervention as assessed by the Pragmatic Robust Implementation and Sustainability Model(Baseline, 12 months, 24 months post-randomization)
- Difference in cost of intervention compared to usual care as assessed by the Pragmatic Robust Implementation and Sustainability Model(Baseline, 12 months, 24 months post-randomization)