Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake
- Conditions
- Primary HypertensionHypertensionNon-Adherence, MedicationNon-Adherence, Patient
- Interventions
- Behavioral: SMS reminders of medicines intake
- Registration Number
- NCT03105687
- Lead Sponsor
- Comenius University
- Brief Summary
By conducting the SPPA trial we try to find out, whether personalized Short Message Service (SMS) reminders of blood pressure-lowering medication can effectively increase patients' adherence to blood pressure-lowering medication. Additionally, we also evaluate their effect on patients' systolic blood pressure control.
- Detailed Description
Hypertension belongs to the main risk factors of cardiovascular diseases, which are the leading cause of morbidity and mortality in the world and in the Slovak Republic. Despite the availability of effective antihypertensive treatment, blood pressure control remains a serious problem. Poor adherence to blood pressure-lowering medication is considered to be the key factor for uncontrolled blood pressure. Studies estimate the overall adherence to medication in patients with chronic diseases at around 50%. Slovak studies report even significantly lower adherence rates (15-19%), which underlines the urgency to address this health problem in the Slovak Republic. The majority of interventions aimed at increasing patients' adherence are associated with substantial costs and health care professionals capacity, both lacking in the current Slovak health care system. Several studies have shown the efficiency of SMS reminders to improve patients' adherence and health outcomes at very low cost. Since mobile phones are frequently used among Slovak inhabitants and SMS messages are a popular mean of communication, this approach could be feasible also in Slovakia. Pharmacists are highly trained drug experts who have the knowledge, skills and time to address patients' nonadherence using a simple SMS reminder system.
Thus, our research question is as follows: Do personalized daily SMS reminders of blood pressure-lowering medication intake provided by pharmacists in addition to standard Pharmaceutical Care reduce the proportion of nonadherence to blood pressure-lowering medication among older ambulatory patients with hypertension in Slovakia? And we hypothesize that personalized daily SMS reminders of blood pressure-lowering medication intake provided by pharmacists in addition to standard Pharmaceutical Care increase the proportion of adherence to blood pressure-lowering medication among older ambulatory patients with hypertension in Slovakia from 30% to 49% in the intervention group compared to the control group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Age ≥ 55 years (from the day of the 55. birthday inclusive)
- Diagnosis of primary (essential) hypertension (I10 according to International Classification of Diseases (ICD-10))
- Filling of blood pressure-lowering prescription(s) at trial recruitment (Visit 1)
- Duration of antihypertensive drug treatment for at least 1 year without any discontinuation
- Ownership of a mobile phone for personal use with the ability to open and read SMS
- Understanding of Slovak language on native-speaker level
- Informed consent for participation in the clinical trial and personally signed Informed Consent Form
Exclusion criteria assessed prior to patient enrolment (by trial pharmacists):
- Planned hospitalisation during the trial period (3 months)
- Biological impairment affecting the ability to read the SMS (e.g. loss of vision, visual field cuts, aphasia)
- Living in the same household with another trial participant
- Participation in another clinical trial
Exclusion criteria assessed after patient enrolment (by trial pharmacists and project leader):
- Hospitalisation during the trial period
- Patient informs he/she won't be able to participate in the trial
- Withdrawal of Informed Consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention SMS reminders of medicines intake Participants in the intervention group will also receive standard Pharmaceutical Care provided by the trial pharmacist, the welcome SMS and the end-of-trial SMS. Additionally, they will receive daily SMS reminders of their blood pressure-lowering medication intake from a trial pharmacist for a period of 3 months after the enrollment. The structure of the SMS reminder will follow the information provided as a part of the usual drug dispensation and counselling process as described in the Slovak national Decree No. 129/2012 Coll. Thus, most of the data are available on the prescription and all of the collected data are already a well-established and required part of the standard Pharmaceutical Care in Slovakia. The simple structure of the SMS reminder will allow for future reproducibility.
- Primary Outcome Measures
Name Time Method Combined adherence endpoint at Visit 2 (follow-up visit after 3 months of intervention period) Measurement variable: adherence status (dichotomous) assessed via the eight item Morisky Medication Score (MMAS-8) as follows:
adherent: MMAS-8 score ≥6 and pill count rate ≥80% or \<=120% non-adherent: MMAS-8 score \<6 and/or pill count rate \<80% or \>120% Analysis Metric: final value (Visit 2) Method of aggregation: proportion of adherent patients (%)
- Secondary Outcome Measures
Name Time Method Patients' satisfaction with SMS reminders. at Visit 2 (at follow-up visit; 3 months after Visit 1) Patient satisfaction will be assessed using a Satisfaction Questionnaire based on previous studies.
Mean Adherence Rate (%) after 3 months calculated via pill count at Visit 2 (at follow-up visit; 3 months after Visit 1) Specific measurement variable: adherence rate (%), continuous variable Analysis Metric: final value (at Visit 2) Method of aggregation: mean
Mean change in systolic BP after 3 months at Visit 2 (at follow-up visit; 3 months after Visit 1) Specific measurement variable: systolic blood pressure in mmHg (continuous variable) Analysis Metric:change from baseline (Visit 1) Method of aggregation: mean
Change in medians of MMAS-8 after 3 months at Visit 2 (at follow-up visit; 3 months after Visit 1) Specific measurement variable: MMAS-8 (categorical, ordinal) Analysis Metric: change from baseline (Visit 1) Method of aggregation: median
Trial Locations
- Locations (24)
Lekáreň DANUBIA
🇸🇰Bratislava, Slovakia
Lekáreň Námestie Osloboditeľov, Dr. Max
🇸🇰Liptovský Mikuláš, Slovakia
Lekáreň Námestie Slobody, Dr. Max
🇸🇰Piešťany, Slovakia
Lekáreň Dr.Max 36
🇸🇰Rožňava, Slovakia
Lekáreň Needham
🇸🇰Banská Bystrica, Slovakia
Lekáreň V KAUFLANDE BB, s.r.o.
🇸🇰Banská Bystrica, Slovakia
Lekáreň Dr.Max 12
🇸🇰Bratislava, Slovakia
Lekáreň Poliklinika Šustekova
🇸🇰Bratislava, Slovakia
Lekáreň GREEN-STRAP
🇸🇰Dubnica nad Váhom, Slovakia
Lekáreň Námestie Matice Slovenskej, Dr. Max
🇸🇰Dubnica nad Váhom, Slovakia
Lekáreň Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša
🇸🇰Galanta, Slovakia
Lekáreň REDMOON
🇸🇰Hnúšťa, Slovakia
Lekáreň 17
🇸🇰Kežmarok, Slovakia
Lekáreň RED-MARKET s.r.o.
🇸🇰Malacky, Slovakia
Lekáreň PRED NEMOCNICOU
🇸🇰Martin, Slovakia
Lekáreň, OC Tulip
🇸🇰Martin, Slovakia
Lekáreň HEALTHSTORE
🇸🇰Prešov, Slovakia
Lekáreň Dr.Max 22
🇸🇰Rimavská Sobota, Slovakia
Lekáreň OC Madaras Dr. Max
🇸🇰Spišská Nová Ves, Slovakia
Lekáreň EURO FARMÁCIA s.r.o.
🇸🇰Trenčín, Slovakia
Lekáreň SD5 s.r.o.
🇸🇰Trenčín, Slovakia
Lekáreň CASTILION
🇸🇰Vranov nad Topľou, Slovakia
Železničná Lekáreň
🇸🇰Zvolen, Slovakia
Lekáreň Bernolákova, Dr. Max
🇸🇰Žilina, Slovakia