Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 主要终点
- cardiovascualr risk factor control
研究概览
简要总结
Patient's awareness of their risk factors for heart disease and their active involvement in their own management plan can help improve their adherence to treatment and their risk profile. The purpose of this study is to investigate the influence of patient education and awareness of heart disease risk factors on compliance to medication and lifestyle modification.
详细描述
Prospective cluster randomized interventional study with primary health care clinics as clusters.Clinics will be randomized to conventional care or to structured patient education in addition to care. Trained physicians will extract information from the patient medical record and will conduct a personal interview with the participants, after they finish with their routine visit, to fill a case report form (CRF)
CRF will include the following items:
- Patient Demographics,
- Socioeconomic: income, employment and education
- Past Medical History
- Smoking history
- Alcohol use
- Medications
- Adherence: Morisky scale
- Examination: BP, weight, height, waist
- Investigations: LDL-C, HbA1C 2.Compliance/adherence to the medication will be measured by using the Morisky scale, which is a validated scale for measuring adherence in hypertension and diabetic patients among other disease.
Patients attending clinics that are randomized to structured patient education will receive education targeting all the risk factors they have. They will be informed about specific evidence -based target values they should achieve for each of the risk factors. Their compliance to prescribed medications will be encouraged and specific advice about improving compliance will be given. To achieve this physicians in the education clinics are going to use two items:
- Framingham Risk Score calculator.
- Know your numbers patient booklet.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with one or more CVD risk factors will be consecutively enrolled, smokers and obese patients should have an additional risk factors
- •The risk factors are based on Framingham Risk Score calculator and include smoking, high blood pressure, high blood cholesterol ,diabetes and being overweight or obese
- •All participants must be adults (30 -70 years of age) who give an informed consent
- •All participants should be of Kuwaity nationality, literate and fluent in either Arabic or English
- •Patients are likely to be available for a one year follow up
排除标准
- •Patients with mental disability or severe psychiatric disorder who are unable to provide informed consent or participate in educational activities.
- •Patients with severe visual or hearing disability that will prevent participation in the educational activity
- •Patients <30 years or >70 years of age
- •Illiterate patients
- •Non Kuwaity nationals
- •Patients who are not permanently resident in Kuwait
- •Patient who refuse to provide the informed consent
结局指标
主要结局
cardiovascualr risk factor control
时间窗: 12 months
Cardiovascular risk factors control as assessed by the following parameters: HbA1C, Blood pressure, LDL-C, BMI and smoking cessation
medication compliance
时间窗: 12 months
Medication compliance as assessed by Morisky scale
次要结局
未报告次要终点
研究者
Dr. Samia Almusallam
Director of the family medicine residency program
Kuwait Institute for Medical Specialization