A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure

Not Applicable

• Conditions: Treatment Adherence and Compliance
• Interventions: Behavioral: mHealth intervention; Behavioral: mHealth intervention and Educational support with peer counseling; Behavioral: Educational support with peer counseling

• Registration Number: NCT05106790
• Lead Sponsor: Universiti Putra Malaysia

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-23
• Study First Submitted QC: 2021-10-24
• Study First Posted: 2021-11-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Study Start: 2022-07-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
mHealth	mHealth intervention	The third group will receive daily written and voice reminders, and once weekly an education-led video in addition to standard care.
Combined arm	mHealth intervention and Educational support with peer counseling	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.
Ed-counseling arm	Educational support with peer counseling	The second group will receive monthly educational support ( booklets) with peer counseling sessions in addition to standard care.

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure (SBP)	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	12- month from baseline	The proportion of participants achieving the control blood pressure \< 140/90 mmHg
Proportion of participants attending scheduled clinic appointments	12- month from baseline	The proportion of participants attending scheduled clinic appointments

Secondary Outcome Measures

Name	Time	Method
Measuring quality of life	12- month from baseline	To measure the health-related quality of life at baseline, three-month, and 12-month post-intervention, EuroQol 5-Dimension- 3-level will be used. The European quality of life scale (EQ-5D-3L) has five dimensions and three levels. Each of the five dimensions comprising the EQ-5D descriptive system is divided into three levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating some problems LEVEL 3: indicating extreme problems, 1 (perfect health), with higher scores indicating higher health utility.; 2- On a 20 cm vertical visual analog scale, the EQ-VAS captures the patient's self-rated health, with two unique endpoints such as "Best imaginable health condition" for a score of 100 and "Worst imaginable health state" for a score of 0.

Trial Locations

Locations (6)

Sheikh Zayed Hospital Rahim Yar Khan; 🇵🇰 Rahim Yar Khan, Punjab, Pakistan

Victoria Hospital; 🇵🇰 Bahawalpur, Punjab, Pakistan

Rehmatul-lil-Almeen Institute of Cardiology; 🇵🇰 Lahore, Pakistan

Sheikh Zayed, Hospital; 🇵🇰 Lahore, Pakistan

Punjab Institute of Cardiology; 🇵🇰 Lahore, Pakistan

Jinnah Hospital; 🇵🇰 Lahore, Pakistan