NCT05106790

A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,440 (estimated)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Treatment Adherence and Compliance

Interventions

Type	Name	Description
BEHAVIORAL	Educational support with peer counseling	This group will receive peer counseling therapy sessions will be led by doctors who specialize in hypertension. Patients and their families will be the focus of the sessions. Face-to-face sessions will take roughly 25-30 minutes. Patients will receive spoken and written instructions based on their abilities during these sessions. The counseling sessions are geared toward overcoming both general and personal obstacles. The educational component will be delivered through smart booklets. Information on hypertension, blood pressure self-monitoring, and frequent systolic blood pressure (SBP) tests, as well as body weight and serum cholesterol values, are included in the instructional support. Food control, exercise therapy, and hypertension problems and their management will also be explored as non-pharmacological therapeutic approaches.
BEHAVIORAL	mHealth intervention	This group will receive mHealth intervention will include daily written and voice messages, and once weekly an educational-led video. This intervention module will be delivered through "WhatsApp".
BEHAVIORAL	mHealth intervention and Educational support with peer counseling	This group will receive both Educational support (Smart booklets) with peer counseling sessions on a monthly basis and mHealth intervention will include daily written and voice reminders, and once weekly an educational led video.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-08-01
• Completion: 2023-09-15
• First posted: 2021-11-04
• Last updated: 2022-05-17

Locations

6 sites across 1 country: Pakistan