mHealth App Intervention to Improve Medication Adherence

University of Putra Malaysia (UPM)

Status: Completed

Conditions: Medication Adherence; Adherence, Treatment

Treatments: Behavioral: mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherence

Study type: Interventional

Funder types: Other

Identifiers

NCT04577157

DPUTRA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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440 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: mHealth using"WhatsApp" multifaceted educational and reminder module intervention to improve adherence

Control Arm

No Intervention group

Description:

Participants in the control group will receive no intervention except in standard care (as per being practiced routinely in the hospitals).