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Completed

NCT Number: NCT03105687

Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake

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.

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Essential Hypertension Health Behavior Medication Adherence Non-Adherence, Medication Non-Adherence, Patient Patient Acceptance of Health Care Patient Compliance Primary Hypertension Treatment Adherence and Compliance Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lekáreň Needham, Banská Bystrica, Slovakia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMS reminders of medicines intake

Behavioral

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

Primary outcomes

  1. 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 (%)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Comenius University

Other

Collaborators

  • Dr. Max Pharmacies
  • Research Institute for Child Psychology and Pathopsychology
  • University of California, Los Angeles

Registry information

Official study 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

Acronym: SPPA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2017
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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