Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake

Hypertension Clinical Trial

— SPPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105687
• Other study ID #: SPPA-2017
• Status: Completed
• Phase: N/A
• First received: March 17, 2017
• Last updated: February 14, 2018
• Start date: June 16, 2017
• Est. completion date: February 14, 2018

Study information

• Verified date: February 2018
• Source: Comenius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 14, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Slovakia	Lekáren Bernolákova, Dr. Max	Žilina
Slovakia	Lekáren Needham	Banská Bystrica
Slovakia	Lekáren V KAUFLANDE BB, s.r.o.	Banská Bystrica
Slovakia	Lekáren DANUBIA	Bratislava
Slovakia	Lekáren Dr.Max 12	Bratislava
Slovakia	Lekáren Poliklinika Šustekova	Bratislava
Slovakia	Lekáren GREEN-STRAP	Dubnica nad Váhom
Slovakia	Lekáren Námestie Matice Slovenskej, Dr. Max	Dubnica nad Váhom
Slovakia	Lekáren Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša	Galanta
Slovakia	Lekáren REDMOON	Hnúšta
Slovakia	Lekáren 17	Kežmarok
Slovakia	Lekáren Námestie Osloboditelov, Dr. Max	Liptovský Mikuláš
Slovakia	Lekáren RED-MARKET s.r.o.	Malacky
Slovakia	Lekáren PRED NEMOCNICOU	Martin
Slovakia	Lekáren, OC Tulip	Martin
Slovakia	Lekáren Námestie Slobody, Dr. Max	Pieštany
Slovakia	Lekáren HEALTHSTORE	Prešov
Slovakia	Lekáren Dr.Max 22	Rimavská Sobota
Slovakia	Lekáren Dr.Max 36	Rožnava
Slovakia	Lekáren OC Madaras Dr. Max	Spišská Nová Ves
Slovakia	Lekáren EURO FARMÁCIA s.r.o.	Trencín
Slovakia	Lekáren SD5 s.r.o.	Trencín
Slovakia	Lekáren CASTILION	Vranov nad Toplou
Slovakia	Železnicná Lekáren	Zvolen

Sponsors (4)

Lead Sponsor	Collaborator
Comenius University	Dr. Max Pharmacies, Research Institute for Child Psychology and Pathopsychology, University of California, Los Angeles

Country where clinical trial is conducted

Slovakia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Signals of adverse events associated with blood pressure-lowering medication	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)
Other	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
Other	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
Primary	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)
Secondary	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)
Secondary	Mean Adherence Rate (%) after 3 months calculated via pill count	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)
Secondary	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)
Secondary	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)

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