Clinical trial NCT05106790: A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Adherence and Compliance
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 1440
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic blood pressure (SBP)
timeFrame: 12- month from baseline
measure: Proportion of participants achieving blood pressure < 140/90 mmHg
timeFrame: 12- month from baseline
measure: Proportion of participants attending scheduled clinic appointments
timeFrame: 12- month from baseline
Secondary outcomes:
measure: Measuring quality of life
timeFrame: 12- month from baseline
Other outcomes:
measure: Change in medication adherence to antihypertensive treatment
timeFrame: 12- month from baseline
Locations:
city: Bahawalpur
country: Pakistan
facility: Victoria Hospital
state: Punjab
city: Rahim Yar Khan
country: Pakistan
facility: Sheikh Zayed Hospital Rahim Yar Khan
state: Punjab
city: Lahore
country: Pakistan
facility: Jinnah Hospital
city: Lahore
country: Pakistan
facility: Punjab Institute of Cardiology
city: Lahore
country: Pakistan
facility: Rehmatul-lil-Almeen Institute of Cardiology
city: Lahore
country: Pakistan
facility: Sheikh Zayed, Hospital
Study officials:
affiliation: UPM
name: Arshed MUHAMMAD
role: PRINCIPAL_INVESTIGATOR
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