mHealth App Intervention to Improve Medication Adherence

NCT04577157 | Completed

• 1 other identifier: DPUTRA
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; Adherence, Treatment

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (1)

• Expected Outcomes

  6-months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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

Interventions

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

Also known as: Mobile health intervention, reminder module intervention,

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Sheikh Zayed, Hospital

Lahore, 54000, Pakistan

Location

Related Publications (19)

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  PMID: 38896837 DERIVED

MeSH Terms

Conditions

Medication Adherence; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Behavior

Study Officials

• Mehwish Kiran, MBBS

  Doctors Hospital, Lahore

  STUDY DIRECTOR

• Arshed Muhammad, MBBS

  UPM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blinded The investigators will be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, student, department of community medicine, faculty of medicine & health sciences, UPM

Model Details: 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).

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: October 6, 2020
• Study Start: January 3, 2021
• Primary Completion: November 6, 2021
• Study Completion: November 30, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)