A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Treatment Adherence and Compliance

Intervention / Treatment
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* Behavioral: Educational support with peer counseling
* Behavioral: mHealth intervention
* Behavioral: mHealth intervention and Educational support with peer counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: It's a 12-month factorial design, intention-to-treat, four-arm, double-blinded, multicentre, pragmatic randomized controlled trial with an intervention to assess the efficacy of mHealth and education support with peer counseling to improve treatment adherence and lower systolic blood pressure in hypertensive patients in three teaching hospitals in Lahore, Pakistan.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care arm<br>The first group will be on standard care as usually being practiced in hospitals. | |
| Active Comparator: Ed-counseling arm<br>The second group will receive monthly educational support ( booklets) with peer counseling sessions in addition to standard care. | Behavioral: Educational support with peer counseling<br>* 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.<br>|
| Active Comparator: mHealth<br>The third group will receive daily written and voice reminders, and once weekly an education-led video in addition to standard care. | Behavioral: mHealth intervention<br>* 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.<br>|
| Active Comparator: Combined arm<br>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. | Behavioral: mHealth intervention and Educational support with peer counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure (SBP) | 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. | 12- month from baseline | 
| Proportion of participants achieving blood pressure < 140/90 mmHg | The proportion of participants achieving the control blood pressure < 140/90 mmHg | 12- month from baseline | 
| Proportion of participants attending scheduled clinic appointments | The proportion of participants attending scheduled clinic appointments | 12- month from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring quality of life | 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. | 12- month from baseline |