Clinical trial NCT04577157: mHealth App Intervention to Improve Medication Adherence
Official title: Effectiveness of mHealth Intervention Using Multifaceted Educational and Reminder Module Intervention to Improve Medication Adherence and Treatment Outcome Among Hypertensive Patients in Lahore, Pakistan: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Adherence, Treatment
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a parallel-design, intention-to-treat, two-arm, randomized controlled trial, six months of duration with intervention module intervention pre-test and post-test evaluations to assess the effectiveness of mHealth application using Multi-aid-package intervention(voice, written message, and multimedia picture) to improve adherence to medication in hypertensive patients in Lahore, Pakistan. Participants will be assigned to the two groups in a parallel fashion in a ratio of 1:1. The intervention group will be given a reminder module intervention and control group with standard care (as per being practiced routinely in the hospitals).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: It is a parallel-design, two-arm, randomized controlled trial designed to assess the effectiveness of mHealth application using 7- items, multifaceted educational and reminder module intervention( written message, voice message, multimedia picture, Graphic based Messages(GBM), video, hypertension at a glance, and doctor support) to improve adherence to medication in hypertensive patients and clinical outcome systolic blood pressure in Lahore, Pakistan. Cost-effectiveness of this study will also be done.

Detailed description: Hypertension is indeed a significant public health concern in Pakistan. Hypertension drastically affects 18.9% of adolescents of age greater than 15 and 33% of adults of age above 45. Uncontrolled blood pressure (BP) is a leading risk factor for major hypertensive complications. In Pakistan, suboptimal adherence to medication remains a stumbling block to the success of antihypertensive treatment. A majority of the population in Pakistan on treatment is found to be non-adherent. mHealth is quite an apt tool positioned to counter these challenges of poor adherence in resource limit settings like Pakistan. What is available is too little to establish any causal relationship. The aim of this study is to assess the effectiveness of mHealth intervention by using a reminder module in improving patient medication adherence in hypertensive patients. The intervention was designed to improve the hypertension-related adherence in participants in the intervention group. The module will be developed and undergone via the process of consultations from a group of experts. These will include professors of epidemiology, one expert in behavioral intervention, two professors of health education, and one cardiologist specialist in hypertension management. For the intervention group, a "multifaceted educational reminder module" will be developed and delivered through "WhatsApp" (written message, voice message, and Graphic-based Reminder (GBR)) by an Information and Technology (IT) facilitator. This will be included daily notes for medication reminders, voice messages,s and Graphic-based Reminders (GBR), Twice-weekly Graphic based Messages(GBM), Lifestyle changing video, hypertension at a glance, and doctor support in addition to the standard care (as per being practiced routinely in the hospitals). WhatsApp is used in this study because of its feature of ticks, which turns out to blue after seeing the message and it is an indication to the sender if the receiver has seen the message, so, the participants no longer need to respond to calls or messages. If the intervention is found effective, it can help in developing educational guidelines for patients to improve their medication adherence and reduce related complications at the same time. This study will give a new line of research for coming researchers in the long run. Moreover, its cost-effectiveness will be assessed to predict one dollar bring about improvement per mmHg.

Eligibility criteria: Inclusion criteria

* Participants with age more than 18 years
* Patients diagnosed with essential hypertension and registered in the cardiology and medical Outpatient Departments (OPDs) of three tertiary care hospitals of Lahore for the last one month.
* Participants on antihypertensive medication
* Only one member from one family.
* Participants have a mobile phone and have "Whatsapp" application installed on their cell phones
* Participants who can operate a mobile phone and can read and send a message on "Whatsapp".

Exclusion Criteria

* Participants with planned travel within two months with no mobile signals.
* Participants with a history of malignancy and require medication adjustment.
* Participants with any planned procedure (during the study period) demand immediate medication changes like CABG, PCI, or CEA (Carotid Endarterectomy)
* Participants who are suffering from dementia, depression (self-reporting)
* Participants with blood-pressure measurement of \>220/\>120 mmHg (symptoms of a hypertensive emergency)
* Participants who are pregnant (self-reporting)
* Participants who are in their lactation period
* Participants within 3 months postpartum

Primary outcomes:
measure: Adherence to medication (Medication Adherence Score)- Self Reported Scale
timeFrame: 6- month from baseline
measure: Change in systolic blood pressure
timeFrame: 6- month from baseline
Secondary outcomes:
Other outcomes:
measure: Expected Outcomes
timeFrame: 6-months
Locations:
city: Lahore
country: Pakistan
facility: Sheikh Zayed, Hospital
Study officials:
affiliation: Doctors Hospital, Lahore
name: Mehwish Kiran, MBBS
role: STUDY_DIRECTOR
affiliation: UPM
name: Arshed Muhammad, MBBS
role: PRINCIPAL_INVESTIGATOR
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