Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake

NCT ID: NCT03105687

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-16
• Study Completion Date: 2018-02-14

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.

Conditions

Hypertension; Primary Hypertension; Non-Adherence, Medication; Non-Adherence, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

SMS reminders of medicines intake

Intervention Type: BEHAVIORAL

The intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Hospitalisation during the trial period
• Patient informs he/she won't be able to participate in the trial
• Withdrawal of Informed Consent

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Research Institute for Child Psychology and Pathopsychology

UNKNOWN

Sponsor Role: collaborator

Dr. Max Pharmacies

UNKNOWN

Sponsor Role: collaborator

Comenius University

OTHER

Sponsor Role: lead

Responsible Party

Zuzana Haramiova

PharmDr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zuzana Haramiova, PharmDr.

Role: STUDY_DIRECTOR

Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy

Magdalena Kuzelova, Prof., PharmDr., PhD.

Role: STUDY_CHAIR

Faculty of Pharmacy Comenius University in Bratislava, Department of Pharmacology and Toxicology

Donald M. Morisky, Sc.D., M.S.P.H., Sc.M.

Role: STUDY_CHAIR

Fielding School of Public Health, Department of Community Health Sciences

Tomas Tesar, Doc., PharmDr., PhD, MBA

Role: STUDY_CHAIR

Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy

Michal Stasko, PharmDr.

Role: STUDY_CHAIR

Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy

Martin Hulin, Ing., Mgr., PhD.

Role: STUDY_CHAIR

Research Institute for Child Psychology and Pathopsychology

Locations

Lekáreň Needham

Banská Bystrica, , Slovakia

Lekáreň V KAUFLANDE BB, s.r.o.

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

Countries

Slovakia

References

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.

Reference Type: BACKGROUND

PMID: 28720121 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33769555 (View on PubMed)

Related Links

https://www.precis-2.org/Trials/251/Scores

PRECIS-2 Index

Other Identifiers

SPPA-2017

Identifier Type: -

Identifier Source: org_study_id