- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03105687
Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake (SPPA)
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Banská Bystrica, Slovakia
- Lekáreň Needham
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Banská Bystrica, Slovakia
- Lekáreň V KAUFLANDE BB, s.r.o.
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Bratislava, Slovakia
- Lekáreň DANUBIA
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Bratislava, Slovakia
- Lekáreň Dr.Max 12
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Bratislava, Slovakia
- Lekáreň Poliklinika Šustekova
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Dubnica nad Váhom, Slovakia
- Lekáreň GREEN-STRAP
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Dubnica nad Váhom, Slovakia
- Lekáreň Námestie Matice Slovenskej, Dr. Max
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Galanta, Slovakia
- Lekáreň Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša
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Hnúšťa, Slovakia
- Lekáreň REDMOON
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Kežmarok, Slovakia
- Lekáreň 17
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Liptovský Mikuláš, Slovakia
- Lekáreň Námestie Osloboditeľov, Dr. Max
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Malacky, Slovakia
- Lekáreň RED-MARKET s.r.o.
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Martin, Slovakia
- Lekáreň PRED NEMOCNICOU
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Martin, Slovakia
- Lekáreň, OC Tulip
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Piešťany, Slovakia
- Lekáreň Námestie Slobody, Dr. Max
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Prešov, Slovakia
- Lekáreň HEALTHSTORE
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Rimavská Sobota, Slovakia
- Lekáreň Dr.Max 22
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Rožňava, Slovakia
- Lekáreň Dr.Max 36
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Spišská Nová Ves, Slovakia
- Lekáreň OC Madaras Dr. Max
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Trenčín, Slovakia
- Lekáreň EURO FARMÁCIA s.r.o.
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Trenčín, Slovakia
- Lekáreň SD5 s.r.o.
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Vranov nad Topľou, Slovakia
- Lekáreň CASTILION
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Zvolen, Slovakia
- Železničná Lekáreň
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Žilina, Slovakia
- Lekáreň Bernolákova, Dr. Max
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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:
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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. |
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EXPERIMENTAL: Intervention
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.
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The intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Combined adherence endpoint
Time Frame: at Visit 2 (follow-up visit after 3 months of intervention period)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in medians of MMAS-8 after 3 months
Time Frame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Specific measurement variable: MMAS-8 (categorical, ordinal) Analysis Metric: change from baseline (Visit 1) Method of aggregation: median
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at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Mean Adherence Rate (%) after 3 months calculated via pill count
Time Frame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Specific measurement variable: adherence rate (%), continuous variable Analysis Metric: final value (at Visit 2) Method of aggregation: mean
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at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Mean change in systolic BP after 3 months
Time Frame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Specific measurement variable: systolic blood pressure in mmHg (continuous variable) Analysis Metric:change from baseline (Visit 1) Method of aggregation: mean
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at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Patients' satisfaction with SMS reminders.
Time Frame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Patient satisfaction will be assessed using a Satisfaction Questionnaire based on previous studies.
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at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall direct treatment costs
Time Frame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
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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.
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at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Signals of adverse events associated with blood pressure-lowering medication
Time Frame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
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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.
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at Visit 2 (at follow-up visit; 3 months after Visit 1)
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Number of patients who refused to participate in the study (Patients Refusal Rate)
Time Frame: Trough enrollment
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We will collect the number of patients who refused to participate in the study and report it as percentage of the overall approached patients.
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Trough enrollment
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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
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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.
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPPA-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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