mHealth App Intervention to Improve Medication Adherence

NCT ID: NCT04577157

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-03
• Study Completion Date: 2021-11-30

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.

Conditions

Medication Adherence; Adherence, Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

1. Daily notes for medication reminders,

2. Daily a voice message with the same content will be delivered.

3. Daily Graphics-based Reminder (GBR).

4. Twice-weekly Graphics-based Messages (GBM) according to Health believe model and Self-determination theory constituents.

5. Once-weekly lifestyle advice through video

6. Hypertension at a glance, complete information will be provided(Optional)

7. 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).

Control Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

1. Daily notes for medication reminders,

2. Daily a voice message with the same content will be delivered.

3. Daily Graphics-based Reminder (GBR).

4. Twice-weekly Graphics-based Messages (GBM) according to Health believe model and Self-determination theory constituents.

5. Once-weekly lifestyle advice through video

6. Hypertension at a glance, complete information will be provided(Optional)

7. 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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Mobile health intervention, reminder module intervention,

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Arshed Muhammad

PhD, student, department of community medicine, faculty of medicine & health sciences, UPM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehwish Kiran, MBBS

Role: STUDY_DIRECTOR

Doctors Hospital, Lahore

Arshed Muhammad, MBBS

Role: PRINCIPAL_INVESTIGATOR

UPM

Locations

Sheikh Zayed, Hospital

Lahore, , Pakistan

Countries

Pakistan

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Other Identifiers

DPUTRA

Identifier Type: -

Identifier Source: org_study_id