Effectiveness of Nurse-Led Telehealth Intervention for Hypertension Control in Nepal
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 706
- 试验地点
- 2
- 主要终点
- Change in Systolic Blood Pressure
研究概览
简要总结
Despite being the leading cause of cardiovascular diseases and premature death worldwide, hypertension control remains a largely unmet challenge for public health systems even in developed countries. Hypertension control in Nepal is challenging due to decreased awareness, limited access to the health facilities caused by geographical constraints and health care personnel shortage. Telehealth can help address these gaps and nurse-led telehealth can be a better option as nurses can provide timely follow up, track patients' progress and offer guidance on medication adherence and lifestyle changes which are crucial for hypertension control.
This study aims to evaluate the effectiveness of nurse-led telehealth for hypertension control among hypertensive adults in Nepal. We will use the Intervention Mapping (IM) approach to develop a theory-based and evidenced nurse-led telehealth intervention for hypertension control. Following IM, a parallel-group 1:1 randomized control trial 353 participants in each group will be used to evaluate the effectiveness of intervention. The intervention consists of regular BP monitoring, video conferencing and virtual drug adjustment. The follow up will be done in 3 and 6 months. Explanatory Sequential mixed Method will be used to assess the acceptability, appropriateness, and feasibility of adapting nurse-led telehealth for hypertension control.
Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analyzed using STATA 14, contributing valuable insights into the potential impact of nurse-led telehealth interventions on increasing hypertension control.
详细描述
Background Hypertension (HTN) is a leading cause of cardiovascular disease and premature death worldwide. About 1.28 billion adults aged 30-79 years are estimated to have HTN; two-thirds of them are living in low and middle-income countries. Globally, 46% of adults with hypertension are estimated to be unaware that they have the condition, only 42% are diagnosed and treated, whereas only 21% have it under control. Hypertension is considered as a silent killer because most people with hypertension are not aware of the condition as it may not present warning signs and symptoms. In 2019, high systolic blood pressure was the top cause of disease burden worldwide, measured by DALYs (Disability-Adjusted Life Years). Despite the enormous burden, hypertension control remains a largely unmet challenge for public health systems, even in developed countries.
The overall prevalence of hypertension in the Asia-Pacific region ranged between 10.6% and 48.3%.6 According to a step survey 2019 in Nepal, 24.5% of adults were hypertensive, with 47.3% unaware of their condition, 29.6% of those with hypertension were receiving treatment, and among those receiving treatment, only 14.8% had their blood pressure under control. Hypertension control in Nepal faces significant challenges due to limited access to health facilities, particularly in rural areas, caused by geographical constraints and healthcare personnel shortages. Low public awareness and inadequate follow-up care further complicate the issue. Additionally, there is limited understanding of the importance of medication adherence and lifestyle modifications, hindering effective hypertension management.
Telemonitoring can help address these gaps by allowing remote monitoring of patients, enabling timely follow-up, and promoting better self-care and treatment adherence, all without the need for frequent visits to health centers. Studies in high-income countries have demonstrated that the telemonitoring of blood pressure effectively improves medication adherence and lifestyle modifications, leading to a reduction in systolic blood pressure (SBP) ranging from 5 mmHg to 32 mmHg. A study in Nepal assessed the effectiveness of mobile phone text messaging intervention where SBP was decreased by 6.5mmHg and diastolic blood pressure (DBP) was decreased by 4.6mmHg.
Traditional physician-led services are usually focused on the medical management of hypertension. However, as part of a holistic approach, counselling and education interventions are considered an essential supplement to medical management, and nurses play a key role in patient education, medication management, and chronic disease monitoring. Nurses can provide timely follow-up, track patient progress, and offer guidance on medication adherence and lifestyle changes, which are crucial for hypertension control.
Rationale/Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30 years and above
- •Blood pressure at baseline of more than 140 or 90 mm Hg on at least two separate visits or under antihypertensive medications
- •Willing to monitor their blood pressure and self-titrate medication
- •Possess a smartphone with internet access and WhatsApp/Viber at least biweekly
- •No cognitive deficit and able to communicate effectively to carry out study tasks
- •Not planning to change residence during the 6-month follow-up
排除标准
- •Pregnant women
- •Patients in hypertensive crisis (BP ≥180/120 mm Hg)
- •Had a stroke in the past 30 days or are on dialysis
- •Individuals with self-reported serious advanced illness such as terminal cancer
- •Patients enrolled in other BP research during the same period
结局指标
主要结局
Change in Systolic Blood Pressure
时间窗: 6 months
It is the difference in Systolic Blood Pressure from the endline to baseline measured in mmHg.
Change in Systolic Blood Pressure
时间窗: 6 months
It is the difference in Systolic Blood Pressure from the endline to baseline measured in mmHg.
次要结局
- Change in Diastolic Blood pressure(6 months)
- Medication Adherence(6 months)
- Hypertension selfcare(6 months)
- Change in Diastolic Blood pressure(6 months)
- Hypertension selfcare(6 months)
- Blood pressure control(6 months)
- Medication Adherence(6 months)
研究者
Bhawana Regmi
Principal Investigator
Kathmandu University School of Medical Sciences
