Study protocol for a randomized control trial investigating the efectiveness of a multifaceted mHealth approach on adherence to antihypertensive treatment among patients in Pakistan

Muhammad Arshed; Aidalina Binti Mahmud; Muhammad Farooq Umer; Fawad Mashhadi; Ayesha Babar Kawish

doi:10.12669/pjms.41.1.9272

Author(s)

Muhammad Arshed University Institute of Public Health,University of Lahore,Defence Road, Near Bhuptian Chowk, Lahore, Pakistan.

Aidalina Binti Mahmud University Institute of Public Health, University of Lahore,Defence Road, Near Bhuptian Chowk, Lahore,Pakistann

Muhammad Farooq Umer University Institute of Public Health, University of Lahore,Defence Road, Near Bhuptian Chowk, Lahore,Pakistan

Fawad Mashhadi University Institute of Public Health, University of Lahore,Defence Road, Near Bhuptian Chowk, Lahore,Pakistan

Ayesha Babar Kawish University Institute of Public Health, University of Lahore,Defence Road, Near Bhuptian Chowk, Lahore,Pakistan

Abstract

Background & Objectives: Poor medication adherence is an essential contributor to Pakistan's high prevalence of uncontrolled hypertension. This study will be aimed to assess the eficacy of a one-of-a-kind developed intervention in improving medication adherence and treatment outcomes in hypertension patients. Methods: Twleve months duration long randomized controlled trial from January to December 2021 will be carried out at Shaikh Zayed Medical Complex (SZMC), Lahore. A total of 440 patients aged 18 years and older diagnosed with hypertension in the last month with non- adherence to antihypertensive therapy <80% of pills used in the last 30 days and have access to a smartphone will be randomized into either the intervention group (n=220) or the control group (n=220). For the intervention arm, a comprehensive intervention, the “Multi-Aid-Package,” consisting of seven items: written, voice, and graphics messages, animated video, educational material, and a 24/7 help service, has been designed. Standard care will be provided to the control group. The primary outcome will be improved adherence to antihypertensive medication, while the secondary outcome will be an alteration in systolic blood pressure (SBP). The analysis will be intention to treat. Conclusion: According to this study, if the multifunctional Multi-Aid-Package proves to be a useful mobile health tool for improving hypertension patients' medication adherence, it will also significantly afect systolic blood pressure. In Pakistan and other comparable low- and middle-income countries LMICs, the Multi-Aid-Package ought to be taken into consideration as a means of enhancing adherence to medications among hypertension patients.

Publication Details

Page(s) 22-28

DOI 10.12669/pjms.41.1.9272

Published Journal: Pakistan Journal of Medical Sciences, Volume: 41, Issue: 1, Year: 2025

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Keywords

Hypertension, Medication Adherence, Mobile health, Mhealth, Interventions

References

Mills KT,Stefanescu A,He J .2020 .The global epidemiology of hypertension. Nat Rev Nephrol, 10 : 223-237.

Kintscher U. .2013 .The burden of hypertension. EuroIntervention, 10(9 Suppl R) : R12-R15.

Bundy JD,Li C,Stuchlik P,Bu X,Kelly TN,Mills KT .2017 .Systolic Blood Pressure Reduction and Risk of Cardiovascular Disease and Mortality: A Systematic Review and Network Meta-analysis. JAMA Cardiol, 10 : 775-781.

ICF .2019 .. Pakistan Demographic and Health Survey, 18 : .

Adnan M,Noor W,Baig MMA .2023 .Risk factors of previously undiagnosed and known untreated hypertension among patients with Type-2 diabetes mellitus. Pak J Med Sci, 10 : 6329-366.

Saeed S,Ali AM,Mahmoud MA,Nilsson PM .2023 .Risk factors of newly detected and masked untreated hypertension in a South Asian population of Type-2 diabetes patients. Pak J Med Sci, 10 : 7666-633.

Boratas S,Kilic HF .2018 .Evaluation of medication adherence in hypertensive patients and influential factors. Pak J Med Sci, 10 : 959-963.

Algameel M. .2020 .Patterns of medication use and adherence to medications among residents in the elderly homes. Pak J Med Sci, 10 : 729-734.

Mahmood S,Jalal Z,Hadi MA,Orooj H,Shah KU .2020 .Non-Adherence to Prescribed Antihypertensives in Primary, Secondary and Tertiary Healthcare Settings in Islamabad, Pakistan: A Cross-Sectional Study. Patient Prefer Adherence, 10 : 73-85.

DiMatteo MR,Haskard KB,Williams SL .2007 .Health beliefs, disease severity, and patient adherence: a meta-analysis. Med Care, 10 : 521-528.

Arshed M,Mahmud AB,Minhat HS,Ying LP .2023 .Effectiveness of mHealth Interventions in Medication Adherence among Patients with Cardiovascular Diseases: A Systematic Review. Diseases, 10 : 41.

Ryu S. Book .2012 .Review: mHealth: New Horizons for Health through Mobile Technologies: Based on the Findings of the Second Global Survey on eHealth (Global Observatory for eHealth Series. Healthc Inform Res, 18 : 231-233.

. .. PTA annual report: 2023, : 29-01.

Arshed M,Mahmud A,Minhat HS,Lim PY,Zakar R .2024 .Effectiveness of a Multifaceted Mobile Health Intervention (Multi-Aid-Package) in Medication Adherence and Treatment Outcomes Among Patients With Hypertension in a Low- to Middle-Income Country: Randomized Controlled Trial. JMIR Mhealth Uhealth, 10 : .

Chan AW,Tetzlaff JM,Altman DG,Laupacis A,Gøtzsche PC,Krleža-Jerić K .2013 .SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med, 10 : 201302050-207.

Arshed M,Umer MF,Kiran M,Akhter AM,Gillani AH,Qamer S .2024 .Prevalence and associated factors of non-adherence to antihyperlipidemic medication: a nationwide cross sectional survey in Pakistan. Sci Rep, 10 : 20613.

Lemeshow S,Lachenbruch PA,Lwanga SK .1991 .Sample Size Determination in Health Studies: A Practical Manual. doi: 10.2307/2290547, 86(416) : .

Zhai P,Hayat K,Ji W,Li Q,Shi L,Atif N .2020 .Efficacy of text messaging and personal consultation by pharmacy students among adults with hypertension: randomized controlled trial. doi: 10.2196/16019, 22 : .

Lim CY,In J .2019 .Randomization in clinical studies. Korean J Anesthesiol, 10 : 221-232.

Risser J,Jacobson TA,Kripalani S. Development .1891 .and psychometric evaluation of the Self-efficacy for Appropriate Medication Use Scale (SEAMS) in low-literacy patients with chronic disease. J Nursing Measur, 15 : 203-219.

Morawski K,Ghazinouri R,Krumme A,Lauffenburger JC,Lu Z,Durfee E .2018 .Association of a Smartphone Application With Medication Adherence and Blood Pressure Control: The MedISAFE-BP Randomized Clinical Trial. JAMA Intern Med, 0447 : 802-809.

Kamal AK,Khalid W,Muqeet A,Jamil A,Farhat K,Gillani SRA .2018 .Making prescriptions “talk” to stroke and heart attack survivors to improve adherence: Results of a randomized clinical trial (The Talking Rx Study). PLoS ONE, 0197671 : .

Arshed M,Zakar R,Umer MF,Kiran M,Ullah N,Iftikhar G .2023 .Ef-fi cacy of mHealth and education-led peer counseling for patients with hypertension and coronary artery disease in Pakistan: study protocol for a double-blinded pragmatic randomized-controlled trial with factorial design. Trials, 10 : 448.

Khan FU,Khan FU,Hayat K,Fang Y. .2024 .Impact of a pharmacist-led patient-centred care intervention along with textmessage reminders, on the management of newly diagnosed tubercular patients: A protocol for a randomized controlled trial. Pak J Med Sci, 10(3) : 5356-491.

Lu N,Liu J,Cai P. .2023 .Analysis of clinical efficacy of comprehensive nursing intervention on elderly patients with hypertension combined with hyperuricemia. Pak J Med Sci, 10(6) : 7233-1724.