A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure

University of Putra Malaysia (UPM)

Status: Unknown

Conditions: Treatment Adherence and Compliance

Treatments: Behavioral: Educational support with peer counseling; Behavioral: mHealth intervention and Educational support with peer counseling; Behavioral: mHealth intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05106790

APUTRA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,440 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,440 participants in 4 patient groups

Standard care arm

No Intervention group

Description:

The first group will be on standard care as usually being practiced in hospitals.

Ed-counseling arm

Active Comparator group

Description:

The second group will receive monthly educational support ( booklets) with peer counseling sessions in addition to standard care.

Treatment:

Behavioral: Educational support with peer counseling

mHealth

Active Comparator group

Description:

The third group will receive daily written and voice reminders, and once weekly an education-led video in addition to standard care.

Treatment:

Behavioral: mHealth intervention

Combined arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: mHealth intervention and Educational support with peer counseling