Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: SMS reminders of medicines intake


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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. | Behavioral: SMS reminders of medicines intake<br>* The intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, SMS reminders, adherence, antihypertensive drugs, pharmacists, cost-effectiveness