The effectiveness of daily SMS reminders in pharmaceutical care of older adults on improving patients' adherence to antihypertensive medication (SPPA): study protocol for a randomized controlled trial

Zuzana Haramiova, Michal Stasko, Martin Hulin, Tomas Tesar, Magdalena Kuzelova, Donald M Morisky, Zuzana Haramiova, Michal Stasko, Martin Hulin, Tomas Tesar, Magdalena Kuzelova, Donald M Morisky

Abstract

Background: Despite a variety of efficient and cost-effective antihypertensive medication, hypertension remains a serious health and economic burden. High consumption of cardiovascular drugs in the Slovak Republic does result neither in better hypertension control nor in significant decrease in cardiovascular mortality. At the same time, Slovakia has alarmingly low patients' adherence to medication intake. Studies have shown the efficiency of short messaging service (SMS) reminders to improve patients' adherence and health outcomes at low costs. Since SMS is popular among Slovaks, this approach may be feasible also in Slovakia. The primary objective is to assess if daily SMS reminders of antihypertensive medication intake provided by pharmacists in addition to the standard pharmaceutical care increase the proportion of adherent older hypertensive ambulatory patients.

Methods: The SPPA trial is a pragmatic randomized parallel group (1:1) trial in 300 older hypertensive patients carried out in community pharmacies in Slovakia. Trial pharmacies will be selected from all main regions of Slovakia. Trial intervention comprises daily personalized SMS reminders of medication intake embedded into usual pharmaceutical practice. The primary outcome is a combined adherence endpoint consisting of subjective self-reported medication adherence via the eight-item Morisky Medication Adherence Scale (MMAS-8) and objective pill count rate. Secondary outcomes include: change in the MMAS-8; comparison of adherence rates using pill count; change in systolic blood pressure; and patient satisfaction. Also, direct treatment costs will be evaluated and a cost-effectiveness analysis will be carried out.

Discussion: The SPPA trial engages community pharmacists and mobile health (mHealth) technologies via evidence-based pharmaceutical care to efficiently and cost-effectively addresses current main healthcare challenges: high prevalence of hypertension; overconsumption of cardiovascular medicines; low adherence to medication treatment; and resulting uncontrolled blood pressure. The results may identify new possibilities and capacities in healthcare with low additional costs and high value to patients.

Trial registration: ClinicalTrials.gov, NCT03105687 . Registered on 07 March 2017.

Keywords: Adherence; Antihypertensive drugs; Cost-effectiveness; Pharmacists; SMS reminders; mHealth.

Conflict of interest statement

Authors’ information

ZH is a Doctor of Pharmacy (PharmD) specialized in clinical trial design conduct and coordination. Currently a PhD candidate of Clinical Pharmacy at the Faculty of Pharmacy, Comenius University in Bratislava. MS is a Doctor of Pharmacy (PharmD, cum laude) specialized in clinical trials monitoring and management. MH is a research expert at the Institute for child psychology and pathopsychology, where he specializes in psychometrics, statistical analysis and modeling. TT is an Associate Professor of Social Pharmacy focusing on Health Technology Assessment, Pharmacoeconomics and Outcome research. Currently the Head of the Department of Organization and Management of Pharmacy at the Faculty of Pharmacy, Comenius University in Bratislava. MK is a Professor of Pharmacology at the Faculty of Pharmacy, Comenius University in Bratislava. She is the Head of the Section of Clinical pharmacology and pharmacotherapy at the Department of Pharmacology and Toxicology at the Faculty of Pharmacy, Comenius University in Bratislava and the guarantee of the PhD study program in Clinical pharmacy. DM is a Professor at the Department of Community Health Sciences, UCLA Fielding School of Public Health. Internationally distinguished expert with profound expertise and experience in planning and evaluation of patient- and community-based health education programs; international health; adherence to medical recommendations; STI/HIVAIDS prevention; hypertension, diabetes, and tuberculosis control.

Ethics approval and consent to participate

Ethics Committee for biomedical research, Faculty of Pharmacy, Comenius University in Bratislava approved the SPPA trial protocol, all trial forms and Informed Consent Form (Multicenter Ethics Committee statement 01/2017). All substantial amendments to the trial protocol or other relevant trial materials will be submitted to the Ethics Committee for biomedical research, Faculty of Pharmacy, Comenius University in Bratislava for approval prior to their implementation in the trial. The Informed Consent Form comprises all information on the study and was prepared in accordance with the WHO international requirements and national legislation. Written informed consent will be obtained from each patient prior to his or her participation in the SPPA trial.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial data procedures and data workflow diagram. euTP external unblinded trial pharmacist, ICF informed consent form, CRF case report form, DM data management
Fig. 2
Fig. 2
SPIRIT figure. TP trial pharmacist, euTP external unblinded trial pharmacist, CG control group, IG intervention group, t0 time of enrolment in the trial, tW time of welcome SMS (one day after enrolment), t intervention duration (trial period), tL time of the last SMS reminder, t1 time of the follow-up visit at the trial pharmacy

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Source: PubMed

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