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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Research Institute for Child Psychology and Pathopsychology | UNKNOWN |
| Dr. Max Pharmacies | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants in the Control group will receive standard Pharmaceutical Care according to the principles of Good Pharmaceutical Practice and national Slovak legislation requirements only. Participants in the control group will also receive a welcome SMS one day after enrollment and an end-of-trial SMS three months after the enrollment. Additionally, prior to their scheduled follow-up visit (Visit 2), three months following the enrollment, trial pharmacists will call the participants to remind them of their follow-up visit. | |
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS reminders of medicines intake | Behavioral | The intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined adherence endpoint | 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 (%) | at Visit 2 (follow-up visit after 3 months of intervention period) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medians of MMAS-8 after 3 months | Specific measurement variable: MMAS-8 (categorical, ordinal) Analysis Metric: change from baseline (Visit 1) Method of aggregation: median | at Visit 2 (at follow-up visit; 3 months after Visit 1) |
| Mean Adherence Rate (%) after 3 months calculated via pill count |
| Measure | Description | Time Frame |
|---|---|---|
| Overall direct treatment costs | Direct treatment costs (monthly average) of blood pressure-lowering medication for each patient will be assessed according to the List of categorized drugs issued by the Ministry of Health of the Slovak Republic. | at Visit 2 (at follow-up visit; 3 months after Visit 1) |
| Signals of adverse events associated with blood pressure-lowering medication |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria assessed prior to patient enrolment (by trial pharmacists):
Exclusion criteria assessed after patient enrolment (by trial pharmacists and project leader):
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| Name | Affiliation | Role |
|---|---|---|
| Zuzana Haramiova, PharmDr. | Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy | Study Director |
| Magdalena Kuzelova, Prof., PharmDr., PhD. | Faculty of Pharmacy Comenius University in Bratislava, Department of Pharmacology and Toxicology | Study Chair |
| Donald M. Morisky, Sc.D., M.S.P.H., Sc.M. | Fielding School of Public Health, Department of Community Health Sciences | Study Chair |
| Tomas Tesar, Doc., PharmDr., PhD, MBA | Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy | Study Chair |
| Michal Stasko, PharmDr. | Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy | Study Chair |
| Martin Hulin, Ing., Mgr., PhD. | Research Institute for Child Psychology and Pathopsychology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lekáreň Needham | Banská Bystrica | Slovakia | ||||
| Lekáreň V KAUFLANDE BB, s.r.o. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28720121 | Background | Haramiova Z, Stasko M, Hulin M, Tesar T, Kuzelova M, Morisky DM. 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. Trials. 2017 Jul 18;18(1):334. doi: 10.1186/s13063-017-2063-8. | |
| 33769555 |
| Label | URL |
|---|---|
| PRECIS-2 Index | View source |
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All collected data will be anonymized and made available on via Open Science Framework
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Specific measurement variable: adherence rate (%), continuous variable Analysis Metric: final value (at Visit 2) Method of aggregation: mean |
| at Visit 2 (at follow-up visit; 3 months after Visit 1) |
| Mean change in systolic BP after 3 months | Specific measurement variable: systolic blood pressure in mmHg (continuous variable) Analysis Metric:change from baseline (Visit 1) Method of aggregation: mean | at Visit 2 (at follow-up visit; 3 months after Visit 1) |
| Patients' satisfaction with SMS reminders. | Patient satisfaction will be assessed using a Satisfaction Questionnaire based on previous studies. | at Visit 2 (at follow-up visit; 3 months after Visit 1) |
During the whole course of the trial we will actively seek for signals of adverse events associated with blood pressure-lowering medication. Patients will have te possibility to report them any time during the trial. Additionally, trial pharmacists will specifically ask the patients about any potential signals of adverse events at Visit 2. |
| at Visit 2 (at follow-up visit; 3 months after Visit 1) |
| Number of patients who refused to participate in the study (Patients Refusal Rate) | We will collect the number of patients who refused to participate in the study and report it as percentage of the overall approached patients. | Trough enrollment |
| Number of participants who withdrew from the study (Participants Withdrawal Rate) | We will collect the number of patients who withdrew from the study (early study termination) and report it as percentage of the overall study participants. Also, anonymous reasons for withdrawal from study will be collected, if the patients wish to provide such information. | From date of randomization until Visit 2 (3 months after Visit 1) or the date of early study termination, whichever came first, assessed up to 3 months |
| Banská Bystrica |
| Slovakia |
| Lekáreň DANUBIA | Bratislava | 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 Námestie Osloboditeľov, Dr. Max | Liptovský Mikuláš | Slovakia |
| Lekáreň RED-MARKET s.r.o. | Malacky | Slovakia |
| Lekáreň PRED NEMOCNICOU | Martin | Slovakia |
| Lekáreň, OC Tulip | Martin | Slovakia |
| Lekáreň Námestie Slobody, Dr. Max | Piešťany | Slovakia |
| Lekáreň HEALTHSTORE | Prešov | Slovakia |
| Lekáreň Dr.Max 22 | Rimavská Sobota | Slovakia |
| Lekáreň Dr.Max 36 | Rožňava | 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 |
| Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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