Efficacy of mHealth and Education-led Peer Counseling of Patients With Hypertension and Coronary Artery Disease: a Double-blinded Pragmatic Randomized Control Trial With Factorial Design, Pakistan
试验速览
- 阶段
- 不适用
- 入组人数
- 1,440
- 试验地点
- 6
- 主要终点
- Change in systolic blood pressure (SBP)
研究概览
简要总结
In Pakistan, poor medication adherence is a key operational factor in the prevalence of uncontrolled hypertension. Mobile phone treatments based on technology are at the forefront and are a reasonably low-cost strategy for combating the latest health concerns associated with poor adherence. On the other hand, conservative approaches to counseling are also found effective. This study will look at how a mHealth-based strategy and an educational-led peer counseling intervention can help hypertensive patients with coronary artery disease lower their systolic blood pressure.
详细描述
In Pakistan, hypertension is a serious public health concern. Hypertension affects 18.9% of teenagers over the age of 15 and 33% of adults over the age of 45; however, only around 3% of hypertensive individuals have their blood pressure regulated to 140/90 mm Hg or lower. The majority of hypertensive patients are found to have blood pressure that is out of control. The majority of those undergoing therapies were judged to be non-compliant. According to the study, adherence to cardiac medications ranged from 27 to 77 percent, while adherence to stroke medications was around 68 percent. According to a recent study, 37.7% of patients did not take their antihypertensive medication as advised.
Interventions to help hypertensive patients in controlling blood pressure show potential to alter their behavior and lead to better outcomes, but delivering them at a cheap cost is difficult. Although evidence is scarce, several trials examining clinical interventions utilizing conventional health education support while others employing a mobile health strategy, both showed significant results. For a low-resource country, we built cost-effective models that are integrated with clinical care for patients with hypertension. The goal of this trial is to assess the effectiveness of mHealth intervention with clinical educational support and educational support with peer counseling to improve blood pressure control in hypertensive patients when compared to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with age 21 to 70 years
- •Participants who have been registered as hypertensive with comorbidity of coronary artery disease in the Outpatient Departments (OPDs) of one of the three public teaching hospitals in Lahore, for at least last one month
- •Participants on antihypertensive drugs
- •The participants with stable coronary artery disease who are treated in an outpatient setting
- •Participants who are willing to sign a written informed consent form, must have a smartphone with the WhatsApp application installed and be able to read Urdu/English.
- •Participants with smartphones and have internet access
排除标准
- •Participants who suffer from some type of malignancy and require adjustment of drugs
- •Participants with any biological condition that makes it difficult for them to read write, communicate or hear phone calls
- •Participants in hypertensive emergency blood pressure >220/120 mmHg
- •Participants with pregnancy(self-reporting)
- •Participants in their period of lactation
研究组 & 干预措施
Standard care arm
The first group will be on standard care as usually being practiced in hospitals.
Ed-counseling arm
The second group will receive monthly educational support ( booklets) with peer counseling sessions in addition to standard care.
干预措施: Educational support with peer counseling (Behavioral)
mHealth
The third group will receive daily written and voice reminders, and once weekly an education-led video in addition to standard care.
干预措施: mHealth intervention (Behavioral)
Combined arm
The fourth group will receive educational support (booklets)and counseling sessions every month, daily written and voice reminders, and once weekly an education-led video in addition to standard care.
干预措施: mHealth intervention and Educational support with peer counseling (Behavioral)
结局指标
主要结局
Change in systolic blood pressure (SBP)
时间窗: 12- month from baseline
The primary outcome is a change in systolic blood pressure (SBP) of participants at 0, 6, and 12 months. The blood pressure will be recorded by sphygmomanometer used was calibrated upper-arm electronic sphygmomanometer (OMRON HEM-7200, OMRON Corporation, Dalian). Two separate readings will be taken within 5 min, and the average measurement will be the final. If the difference between the two measurements will be more than 5mmHg, then a third recording will be done and the average is considered.
Proportion of participants achieving blood pressure < 140/90 mmHg
时间窗: 12- month from baseline
The proportion of participants achieving the control blood pressure \< 140/90 mmHg
Proportion of participants attending scheduled clinic appointments
时间窗: 12- month from baseline
The proportion of participants attending scheduled clinic appointments
次要结局
- Measuring quality of life(12- month from baseline)
研究者
Arshed Muhammad
PhD studentship
Universiti Putra Malaysia