mHealth App Intervention to Improve Medication Adherence

Medication Adherence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577157
• Other study ID #: DPUTRA
• Status: Completed
• Phase: N/A
• Start date: January 3, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: November 30, 2021
• Est. primary completion date: November 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Treatment
• Medication Adherence

Intervention

Behavioral:
• 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. 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).

Locations

Country	Name	City	State
Pakistan	Sheikh Zayed, Hospital	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Pakistan, 

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expected Outcomes	A significant difference in treatment adherence is expected in the intervention group compared to the control group. [ Time Frame: At 6-months ]; Self-reported adherence to antihypertensive treatment [ Time Frame: At 6-months ]; The proportion of participants with a systolic blood pressure < 140 mmHg and a diastolic blood pressure <90 mmHg [ Time Frame: At 6-months ]	6-months
Primary	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
Primary	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