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Trial record 29 of 663 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT03105687
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : February 16, 2018
Sponsor:
Collaborators:
University of California, Los Angeles
Research Institute for Child Psychology and Pathopsychology
Dr. Max Pharmacies
Information provided by (Responsible Party):
Zuzana Haramiova, Comenius University

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.

Condition or disease Intervention/treatment Phase
Hypertension Primary Hypertension Non-Adherence, Medication Non-Adherence, Patient Behavioral: SMS reminders of medicines intake Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 16, 2017
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105687


Locations
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Slovakia
Lekáreň Needham
Banská Bystrica, Slovakia
Lekáreň V KAUFLANDE BB, s.r.o.
Banská Bystrica, Slovakia
Lekáreň DANUBIA
Bratislava, Slovakia
Lekáreň Dr.Max 12
Bratislava, Slovakia
Lekáreň Poliklinika Šustekova
Bratislava, Slovakia
Lekáreň GREEN-STRAP
Dubnica nad Váhom, Slovakia
Lekáreň Námestie Matice Slovenskej, Dr. Max
Dubnica nad Váhom, Slovakia
Lekáreň Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša
Galanta, Slovakia
Lekáreň REDMOON
Hnúšťa, Slovakia
Lekáreň 17
Kežmarok, Slovakia
Lekáreň Námestie Osloboditeľov, Dr. Max
Liptovský Mikuláš, Slovakia
Lekáreň RED-MARKET s.r.o.
Malacky, Slovakia
Lekáreň PRED NEMOCNICOU
Martin, Slovakia
Lekáreň, OC Tulip
Martin, Slovakia
Lekáreň Námestie Slobody, Dr. Max
Piešťany, Slovakia
Lekáreň HEALTHSTORE
Prešov, Slovakia
Lekáreň Dr.Max 22
Rimavská Sobota, Slovakia
Lekáreň Dr.Max 36
Rožňava, Slovakia
Lekáreň OC Madaras Dr. Max
Spišská Nová Ves, Slovakia
Lekáreň EURO FARMÁCIA s.r.o.
Trenčín, Slovakia
Lekáreň SD5 s.r.o.
Trenčín, Slovakia
Lekáreň CASTILION
Vranov nad Topľou, Slovakia
Železničná Lekáreň
Zvolen, Slovakia
Lekáreň Bernolákova, Dr. Max
Žilina, Slovakia
Sponsors and Collaborators
Comenius University
University of California, Los Angeles
Research Institute for Child Psychology and Pathopsychology
Dr. Max Pharmacies
Investigators
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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

Additional Information:
Publications:
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Responsible Party: Zuzana Haramiova, PharmDr., Comenius University
ClinicalTrials.gov Identifier: NCT03105687     History of Changes
Other Study ID Numbers: SPPA-2017
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data will be anonymized and made available on via Open Science Framework

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zuzana Haramiova, Comenius University:
mHealth
SMS reminders
adherence
antihypertensive drugs
pharmacists
cost-effectiveness
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases