Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake (SPPA)
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|ClinicalTrials.gov Identifier: NCT03105687|
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : February 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Primary Hypertension Non-Adherence, Medication Non-Adherence, Patient||Behavioral: SMS reminders of medicines intake||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Multicenter, Assessor-blinded, Controlled, Randomised, Parallel Group, Superiority, Pragmatic Trial Assessing the Effectiveness of Daily SMS-reminders in Pharmaceutical Care of Older Adults With Hypertension on Improving Patients' Adherence to Blood Pressure-lowering Medication|
|Actual Study Start Date :||June 16, 2017|
|Actual Primary Completion Date :||January 10, 2018|
|Actual Study Completion Date :||February 14, 2018|
No Intervention: Control
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.
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.
Behavioral: SMS reminders of medicines intake
The intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months.
- Combined adherence endpoint [ Time Frame: 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 (%)
- Change in medians of MMAS-8 after 3 months [ Time Frame: 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
- Mean Adherence Rate (%) after 3 months calculated via pill count [ Time Frame: 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 [ Time Frame: 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
- Patients' satisfaction with SMS reminders. [ Time Frame: 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.
- Overall direct treatment costs [ Time Frame: at Visit 2 (at follow-up visit; 3 months after Visit 1) ]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.
- Signals of adverse events associated with blood pressure-lowering medication [ Time Frame: 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.
- Number of patients who refused to participate in the study (Patients Refusal Rate) [ Time Frame: Trough enrollment ]We will collect the number of patients who refused to participate in the study and report it as percentage of the overall approached patients.
- Number of participants who withdrew from the study (Participants Withdrawal Rate) [ Time Frame: 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105687
|Banská Bystrica, Slovakia|
|Lekáreň V KAUFLANDE BB, s.r.o.|
|Banská Bystrica, Slovakia|
|Lekáreň Dr.Max 12|
|Lekáreň Poliklinika Šustekova|
|Dubnica nad Váhom, Slovakia|
|Lekáreň Námestie Matice Slovenskej, Dr. Max|
|Dubnica nad Váhom, Slovakia|
|Lekáreň Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša|
|Lekáreň Námestie Osloboditeľov, Dr. Max|
|Liptovský Mikuláš, Slovakia|
|Lekáreň RED-MARKET s.r.o.|
|Lekáreň PRED NEMOCNICOU|
|Lekáreň, OC Tulip|
|Lekáreň Námestie Slobody, Dr. Max|
|Lekáreň Dr.Max 22|
|Rimavská Sobota, Slovakia|
|Lekáreň Dr.Max 36|
|Lekáreň OC Madaras Dr. Max|
|Spišská Nová Ves, Slovakia|
|Lekáreň EURO FARMÁCIA s.r.o.|
|Lekáreň SD5 s.r.o.|
|Vranov nad Topľou, Slovakia|
|Lekáreň Bernolákova, Dr. Max|
|Study Director:||Zuzana Haramiova, PharmDr.||Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy|
|Study Chair:||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|