Clinical trial NCT03105687: Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Primary Hypertension
Non-Adherence, Medication
Non-Adherence, Patient
Keywords: mHealth
SMS reminders
adherence
antihypertensive drugs
pharmacists
cost-effectiveness
Lead sponsor: Comenius University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Research Institute for Child Psychology and Pathopsychology
name: Dr. Max Pharmacies
First posted: 2017-04-10
Enrollment: 300
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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:

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

Primary outcomes:
measure: Combined adherence endpoint
timeFrame: at Visit 2 (follow-up visit after 3 months of intervention period)
Secondary outcomes:
measure: Change in medians of MMAS-8 after 3 months
timeFrame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
measure: Mean Adherence Rate (%) after 3 months calculated via pill count
timeFrame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
measure: Mean change in systolic BP after 3 months
timeFrame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
measure: Patients' satisfaction with SMS reminders.
timeFrame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
Other outcomes:
measure: Overall direct treatment costs
timeFrame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
measure: Signals of adverse events associated with blood pressure-lowering medication
timeFrame: at Visit 2 (at follow-up visit; 3 months after Visit 1)
measure: Number of patients who refused to participate in the study (Patients Refusal Rate)
timeFrame: Trough enrollment
measure: Number of participants who withdrew from the study (Participants Withdrawal Rate)
timeFrame: 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
Locations:
city: Banská Bystrica
country: Slovakia
facility: Lekáreň Needham
city: Banská Bystrica
country: Slovakia
facility: Lekáreň V KAUFLANDE BB, s.r.o.
city: Bratislava
country: Slovakia
facility: Lekáreň DANUBIA
city: Bratislava
country: Slovakia
facility: Lekáreň Dr.Max 12
city: Bratislava
country: Slovakia
facility: Lekáreň Poliklinika Šustekova
city: Dubnica nad Váhom
country: Slovakia
facility: Lekáreň GREEN-STRAP
city: Dubnica nad Váhom
country: Slovakia
facility: Lekáreň Námestie Matice Slovenskej, Dr. Max
city: Galanta
country: Slovakia
facility: Lekáreň Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša
city: Hnúšťa
country: Slovakia
facility: Lekáreň REDMOON
city: Kežmarok
country: Slovakia
facility: Lekáreň 17
city: Liptovský Mikuláš
country: Slovakia
facility: Lekáreň Námestie Osloboditeľov, Dr. Max
city: Malacky
country: Slovakia
facility: Lekáreň RED-MARKET s.r.o.
city: Martin
country: Slovakia
facility: Lekáreň PRED NEMOCNICOU
city: Martin
country: Slovakia
facility: Lekáreň, OC Tulip
city: Piešťany
country: Slovakia
facility: Lekáreň Námestie Slobody, Dr. Max
city: Prešov
country: Slovakia
facility: Lekáreň HEALTHSTORE
city: Rimavská Sobota
country: Slovakia
facility: Lekáreň Dr.Max 22
city: Rožňava
country: Slovakia
facility: Lekáreň Dr.Max 36
city: Spišská Nová Ves
country: Slovakia
facility: Lekáreň OC Madaras Dr. Max
city: Trenčín
country: Slovakia
facility: Lekáreň EURO FARMÁCIA s.r.o.
city: Trenčín
country: Slovakia
facility: Lekáreň SD5 s.r.o.
city: Vranov nad Topľou
country: Slovakia
facility: Lekáreň CASTILION
city: Zvolen
country: Slovakia
facility: Železničná Lekáreň
city: Žilina
country: Slovakia
facility: Lekáreň Bernolákova, Dr. Max
Study officials:
affiliation: Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy
name: Zuzana Haramiova, PharmDr.
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy Comenius University in Bratislava, Department of Pharmacology and Toxicology
name: Magdalena Kuzelova, Prof., PharmDr., PhD.
role: STUDY_CHAIR
affiliation: Fielding School of Public Health, Department of Community Health Sciences
name: Donald M. Morisky, Sc.D., M.S.P.H., Sc.M.
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy
name: Tomas Tesar, Doc., PharmDr., PhD, MBA
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy
name: Michal Stasko, PharmDr.
role: STUDY_CHAIR
affiliation: Research Institute for Child Psychology and Pathopsychology
name: Martin Hulin, Ing., Mgr., PhD.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.