mHealth App Intervention to Improve Medication Adherence

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: 320

Summary

Conditions

Adherence, Treatment
Medication Adherence

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: It is a parallel-design, intention-to-treat, two-arm, multicenter, randomized controlled trial, six months of duration with intervention module intervention pre-test and post-test evaluations to assess the effectiveness of mobile health application using reminder module intervention(voice, written message, and multimedia picture) to improve adherence to medication in hypertensive patients in three tertiary care hospitals of 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: Triple (Participant, Care Provider, Investigator)Masking Description: Double-blinded The investigators will be blinded.Primary Purpose: Health Services Research

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

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.

Tracking Information

NCT #: NCT04577157
Collaborators: Not Provided
Investigators: Study Director: Mehwish Kiran, MBBS Doctors Hospital, Lahore Principal Investigator: Arshed Muhammad, MBBS UPM