mHealth App Intervention to Improve Medication Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Medication Adherence, Adherence, Treatment

Intervention / Treatment
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* Behavioral: mHealth usingWhatsApp multifaceted educational and reminder module intervention to improve adherence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>The participants in the intervention group will receive Health@click (seven-item multifaceted educational and reminder module) through WhatsApp. This will be included daily notes for medication reminders, voice messages, Graphics-based Reminders (GBR), Twice-weekly Graphics-based Messages (GBM), and once-weekly lifestyle advice through video in addition to standard care (as being practiced routinely in the hospitals). Besides this, a 24/7 help provision service will be given to the participants. A qualified doctor will be there to provide this educational support. Support will be including the dose of medicine, frequency, mode of action, effects of medicine on current illness, side effects and interaction with different foods, and psychological support to the participants who feel the need. | Behavioral: mHealth usingWhatsApp multifaceted educational and reminder module intervention to improve adherence<br>* This multifaceted educational and reminder module is named Health@click. The content of the reminder module has been made based on The Health Belief Model and self-determination theory. Daily notes for medication reminders, Daily a voice message with the same content will be delivered. Daily Graphics-based Reminder (GBR). Twice-weekly Graphics-based Messages (GBM) according to Health believe model and Self-determination theory constituents. Once-weekly lifestyle advice through video Hypertension at a glance, complete information will be provided(Optional) 24/7 help provision service will be given to the participants. A qualified doctor will be there to provide this educational support. Support will be including the dose of medicine, frequency, mode of action, effects of medicine on current illness, side effects, and interaction with different foods (Optional).<br>* Other names: Mobile health intervention, reminder module intervention,;|
| No Intervention: Control Arm<br>Participants in the control group will receive no intervention except in standard care (as per being practiced routinely in the hospitals). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to medication (Medication Adherence Score)- Self Reported Scale | The primary outcome is (change) medication adherence to antihypertensive treatment (AHT) at 6 months. This will be assessed by self-reporting using a Standardized questionnaire, Self-efficacy for Appropriate Medication Adherence Scale (SEAMS) at 0, 3, and 6 months. It is a 13-item scale with a three-point response questionnaire, with (1 _ not confident, 2 _ somewhat confident and 3 _ very confident). The potential score for the 13-item scale ranged from 13 to 39. Higher scores indicated higher levels of self-efficacy for medication adherence and vice versa. Besides SEAMS, adherence rates will be also be calculated by 'pills taken over a specific period of time, divided by pills prescribed for that specific period of time. The cut-off value of 80% is set. Less than 80% will be considered non-adherent while >80% will be adherent. It will be self-reporting. | 6- month from baseline | 
| Change in systolic blood pressure | The secondary outcome is a change in systolic blood pressure (SBP) of participants at 6 months. This will be assessed on measuring blood pressure at the hospital by a blinded staff nurse at 0, 3, and 6 months at the hospital by a blinded staff nurse using the calibrated upper-arm electronic sphygmomanometer (OMRON HEM-7200, OMRON Corporation, Dalian) with standard guidelines. | 6- month from baseline |