Optimising a Community-based Model for Case Identification, Monitoring, and Prevention of Hypertension and Diabetes Among Syrian Refugees in Jordan
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Proportion of diabetes patients at intake (defined as random blood sugar >= 200 mg/dL at intake) demonstrating a change in random blood sugar (mmHg)
研究概览
简要总结
The project will investigate and improve a community health worker (CHW) based model for non-communicable disease (NCD) care in a humanitarian emergency.
详细描述
Guidelines for public health approaches for non-communicable disease (NCD) in crises are not well developed. More broadly, NCD management in developing countries focuses on care at the health facility level without a community health worker focus (CHW), which may facilitate continuous care and monitoring.
Since the arrival of refugees from Syria in 2012, the International Rescue Committee (IRC) has provided primary health care, mobile outreach, and community-based empowerment programs for those in need in the northern governorates of Mafraq and Ramtha. The IRC runs health clinics, mobile medical teams, and community health volunteer (CHV) networks to provide care for refugees and Jordanians living in poverty.
This stepped-wedge observational study will follow the implementation of an improved CHV program which focuses on the monitoring of 'high-needs' patients in their households for complications, severe disease, and to avoid interruptions to treatment adherence. The stepped-wedge design will be undertaken to benefit from the phased rollout of the improved CHV intervention over a year-long period. The intervention will be scaled to 20 CHV-neighborhoods across Mafraq and Ramtha.
Primary objectives:
- To evaluate the impact of an improved CHV program that targets high-needs hypertension and diabetes patients on:
- Compliance with routine clinic visits.
- Adherence to medications (self-reported).
- Adherence behaviours (self-reported).
- Disease control outcomes (blood pressure control for hypertension patients; blood sugar control for diabetes patients).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥18 years of age) with clinically-diagnosed hypertension OR type II diabetes AND;
- •Poor adherence, defined as:
- •Missed ≥2 appointments in the past six months AND/OR;
- •Poor disease control:
- •Hypertension: Blood pressure >160/90 (EHS/ESC Grade II/III) with or without therapy, on their last measurement in clinic AND/OR; Evidence of hypertensive end organ damage including ischemic heart disease, left ventricular hypertrophy on ECG, eGFR < 60, hypertensive retinopathy, heart failure, myocardial infarction AND/OR; Type II diabetes: HbA1C is >8.5% OR random blood glucose >200 mg/dL with or without insulin/pill therapy AND/OR; Patient has comorbidity and/or evidence of diabetic end organ damage, including ischemic heart disease, left ventricular hypertrophy on ECG, eGFR < 60, retinopathy, heart failure, myocardial infarction, poorly healing wounds (e.g., diabetic foot), amputation, blindness and eye problems.
- •Comorbid diabetes and hypertension:
- •Disabled (house-bound)
- •Type I diabetes (insulin-dependent): all adult cases of insulin-dependent diabetes (likely type I diabetes), due to the nature of treatment interruption which causes rapid decompensations.
排除标准
- •Pregnancy
- •Hospitalization for the majority of the study period
- •Patients who leave the study neighborhood or repatriate to Syria
结局指标
主要结局
Proportion of diabetes patients at intake (defined as random blood sugar >= 200 mg/dL at intake) demonstrating a change in random blood sugar (mmHg)
时间窗: Every two months, through study completion (4 to 12 months depending on group)
As measured by point-of-care glucometer
Proportion of patients demonstrating a change in self-reported medication adherence actions (5-day)
时间窗: Every two months, through study completion (4 to 12 months depending on group)
As measured the number of days during the last 5 days in which medication was not taken (during household visit)
Proportion of patients demonstrating a change in self-reported medication adherence actions (30-day)
时间窗: Every two months, through study completion (4 to 12 months depending on group)
As measured the number of days during the last 30 days in which medication was not taken (during household visit)
Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in systolic blood pressure (mmHg)
时间窗: Every two months, through study completion (4 to 12 months depending on group)
As measured by electronic blood pressure monitor during household visit
Proportion of patients demonstrating a change in self-reported medication adherence behaviors
时间窗: Every two months, through study completion (4 to 12 months depending on group)
As measured by response to questions on adherence behaviors. This measure uses the Center for Adherence Support Evaluation (CASE) Adherence Index, wherein higher values on a scale of 1 to 6 indicate worse outcomes.
次要结局
- Proportion of patients demonstrating a change in disease control (defined as blood pressure <140/90 mmHg; <150/90 for patients aged ≥80 years), among patients with hypertension at intake (defined as blood pressure >=140/90 mmHg at intake)(Every two months, through study completion (4 to 12 months depending on group))
- Proportion of hypertension patients at intake (defined as blood pressure >=140/90 mmHg at intake) demonstrating a change in diastolic blood pressure (mmHg)(Every two months, through study completion (4 to 12 months depending on group))
- Proportion of patients demonstrating a change in disease control (defined as random blood sugar <200 mg/dL mmHg), among patients with diabetes at intake (defined as random blood sugar >=200 mg/dL at intake)(Every two months, through study completion (4 to 12 months depending on group))