Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake (SPPA)

February 14, 2018 updated by: Zuzana Haramiova, Comenius University

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Banská Bystrica, Slovakia
        • Lekáreň Needham
      • Banská Bystrica, Slovakia
        • Lekáreň V KAUFLANDE BB, s.r.o.
      • Bratislava, Slovakia
        • Lekáreň DANUBIA
      • Bratislava, Slovakia
        • Lekáreň Dr.Max 12
      • Bratislava, Slovakia
        • Lekáreň Poliklinika Šustekova
      • Dubnica nad Váhom, Slovakia
        • Lekáreň GREEN-STRAP
      • Dubnica nad Váhom, Slovakia
        • Lekáreň Námestie Matice Slovenskej, Dr. Max
      • Galanta, Slovakia
        • Lekáreň Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša
      • Hnúšťa, Slovakia
        • Lekáreň REDMOON
      • Kežmarok, Slovakia
        • Lekáreň 17
      • Liptovský Mikuláš, Slovakia
        • Lekáreň Námestie Osloboditeľov, Dr. Max
      • Malacky, Slovakia
        • Lekáreň RED-MARKET s.r.o.
      • Martin, Slovakia
        • Lekáreň PRED NEMOCNICOU
      • Martin, Slovakia
        • Lekáreň, OC Tulip
      • Piešťany, Slovakia
        • Lekáreň Námestie Slobody, Dr. Max
      • Prešov, Slovakia
        • Lekáreň HEALTHSTORE
      • Rimavská Sobota, Slovakia
        • Lekáreň Dr.Max 22
      • Rožňava, Slovakia
        • Lekáreň Dr.Max 36
      • Spišská Nová Ves, Slovakia
        • Lekáreň OC Madaras Dr. Max
      • Trenčín, Slovakia
        • Lekáreň EURO FARMÁCIA s.r.o.
      • Trenčín, Slovakia
        • Lekáreň SD5 s.r.o.
      • Vranov nad Topľou, Slovakia
        • Lekáreň CASTILION
      • Zvolen, Slovakia
        • Železničná Lekáreň
      • Žilina, Slovakia
        • Lekáreň Bernolákova, Dr. Max

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%)

at Visit 2 (follow-up visit after 3 months of intervention period)

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)
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)
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
at Visit 2 (at follow-up visit; 3 months after Visit 1)
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
at Visit 2 (at follow-up visit; 3 months after Visit 1)
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.
at Visit 2 (at follow-up visit; 3 months after Visit 1)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at Visit 2 (at follow-up visit; 3 months after Visit 1)
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.
at Visit 2 (at follow-up visit; 3 months after Visit 1)
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.
Trough enrollment
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 16, 2017

Primary Completion (ACTUAL)

January 10, 2018

Study Completion (ACTUAL)

February 14, 2018

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (ACTUAL)

April 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data will be anonymized and made available on via Open Science Framework

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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