Effectiveness of Customized Interventions on Therapeutic Response and Quality of Life among the Adults with H hypertension attending medicine OPDs of selected hospital in Sikkim A Randomized Controlled Trial
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Sikkim Manipal College of Nursing
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Serum homocysteine level and Blood pressure
概览
简要总结
The current study is a Randomized Controlled Trial among the adults with H-hypertension attending medicine OPDs of selected hospital in Sikkim. The objectives are to assess the proportion of H-hypertension in phase 1 & in phase 2, to find the effectiveness of customized interventions on therapeutic response among the subjects in experimental group as compared to the control group at baseline, two, four and six months. The primary outcome is to reduce the serum homocysteine level among participants with H-hypertension thereby reducing the blood pressure & the secondary outcome is the controlled blood pressure may contribute towards maintaining the QoL of the participant, the adherence to antihypertensives and dietary practices will be emphasized so that it will also contribute positively towards reduction of homocysteine and control of hypertension and prevent complications leading to CADs, MI, Heart attack, Heart failure, Stroke and CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Phase 1 550 sample size Age 19-60 years willing to participate in the study Able to read and understand English Nepali language Phase 2 104 sample size Adults diagnosed to have H hypertension in phase 1 The participants will be randomized into experimental and control group 54 each in both group but it will be recalculated after the finding of the phase 1.
排除标准
- •Phase 1 Hypertensive adults with comorbidities such as Coronary Artery Disease Myocardial Infarction Heart Failure Heart attack Stroke Diabetes Mellitus Chronic Kidney Disease Physical and or Mental disability Adults who are under folic acid and vitamin B supplementation adults with the report of serum homocysteine level more than 15micromole per liter Phase 2 Adults with Baseline systolic BP 180mmHg and diastolic BP 110mmHg Report of serum homocysteine level more than 15micromole per liter.
结局指标
主要结局
Serum homocysteine level and Blood pressure
时间窗: During enrollment to the study | 2nd month after intervention | 4th month after intervention | 6th month after intervention
次要结局
- Adherence to antihypertensives(Adherence to dietary practices and Quality of Life)
研究者
Wangkheimayum Ashalata Devi
Sikkim Manipal College of Nursing Sikkim Manipal University