HypertensionSPPANCT03105687
Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake
A study testing SMS reminders of medicines intake in people with Hypertension and Primary Hypertension, run by Comenius University at 24 sites in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hypertension, Primary Hypertension, Non-Adherence, Medication
- What is being tested?
- SMS reminders of medicines intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 24 sitesSlovakia
- Study dates
- 16 Jun 2017to 14 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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):
Show all 9Show fewer
- Hospitalisation during the trial period
- Patient informs he/she won't be able to participate in the trial
- Withdrawal of Informed Consent
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Slovakia24 sites
Lekáreň Needham
Banská Bystrica
Lekáreň V KAUFLANDE BB, s.r.o.
Banská Bystrica
Lekáreň DANUBIA
Bratislava
Lekáreň Dr.Max 12
Bratislava
Lekáreň Poliklinika Šustekova
Bratislava
Lekáreň GREEN-STRAP
Dubnica nad Váhom
Lekáreň Námestie Matice Slovenskej, Dr. Max
Dubnica nad Váhom
Lekáreň Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša
Galanta
Lekáreň REDMOON
Hnúšťa
Lekáreň 17
Kežmarok
Lekáreň Námestie Osloboditeľov, Dr. Max
Liptovský Mikuláš
Lekáreň RED-MARKET s.r.o.
Malacky
Lekáreň PRED NEMOCNICOU
Martin
Lekáreň, OC Tulip
Martin
Lekáreň Námestie Slobody, Dr. Max
Piešťany
Lekáreň HEALTHSTORE
Prešov
Lekáreň Dr.Max 22
Rimavská Sobota
Lekáreň Dr.Max 36
Rožňava
Lekáreň OC Madaras Dr. Max
Spišská Nová Ves
Lekáreň EURO FARMÁCIA s.r.o.
Trenčín
Lekáreň SD5 s.r.o.
Trenčín
Lekáreň CASTILION
Vranov nad Topľou
Lekáreň Bernolákova, Dr. Max
Žilina
Železničná Lekáreň
Zvolen
About this study
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
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.
Read the 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.
- Being tested
- SMS reminders of medicines intake
- Keywords
- mHealth, SMS reminders, adherence, antihypertensive drugs, pharmacists, cost-effectiveness
- Medical subject headings
- Hypertension, Essential Hypertension, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS reminders of medicines intakeBehavioural
The intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention | Experimental | 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. Receives: Behavioral: SMS reminders of medicines intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: at Visit 2 (follow-up visit after 3 months of intervention period)
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: at Visit 2 (at follow-up visit; 3 months after Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start16 Jun 2017
- Primary completion10 Jan 2018
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Research Institute for Child Psychology and Pathopsychology, Dr. Max Pharmacies
- Responsible party
- Principal investigator, Zuzana Haramiova, Comenius University
- Investigators
- Zuzana Haramiova, PharmDr., Study director, Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of PharmacyMagdalena Kuzelova, Prof., PharmDr., PhD., Study chair, Faculty of Pharmacy Comenius University in Bratislava, Department of Pharmacology and ToxicologyDonald M. Morisky, Sc.D., M.S.P.H., Sc.M., Study chair, Fielding School of Public Health, Department of Community Health SciencesTomas Tesar, Doc., PharmDr., PhD, MBA, Study chair, Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of PharmacyMichal Stasko, PharmDr., Study chair, Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of PharmacyMartin Hulin, Ing., Mgr., PhD., Study chair, Research Institute for Child Psychology and Pathopsychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105687
- Sponsor's protocol ID
- SPPA-2017
- Acronym
- SPPA
- Status last verified
- Feb 2018
- First submitted
- 17 Mar 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data will be anonymized and made available on via Open Science Framework
Publications
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.
PubMed 28720121Palmer 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.
PubMed 33769555
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03105687
- Acronym / sponsor ID
- SPPA / SPPA-2017
- Keywords
- mHealth, SMS reminders, adherence, antihypertensive drugs, pharmacists, cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Research Institute for Child Psychology and Pathopsychology, Dr. Max Pharmacies
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention | Experimental | Behavioral: SMS reminders of medicines intakeParticipants 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS reminders of medicines intakeThe intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months. | Behavioural | Intervention |
Primary outcome
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 (%)
4 secondary outcomes
Change in medians of MMAS-8 after 3 months
Time frame: 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)
Mean change in systolic BP after 3 months
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Background: PubMed 28720121Haramiova 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.
- Derived from this study: PubMed 33769555Palmer 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.
- PRECIS-2 IndexLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected data will be anonymized and made available on via Open Science Framework
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuzana Haramiova, PharmDr. study director
Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy
Magdalena Kuzelova, Prof., PharmDr., PhD. study chair
Faculty of Pharmacy Comenius University in Bratislava, Department of Pharmacology and Toxicology
Donald M. Morisky, Sc.D., M.S.P.H., Sc.M. study chair
Fielding School of Public Health, Department of Community Health Sciences
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminders of medicines intake in people with Hypertension and Primary Hypertension, run by Comenius University at 24 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined adherence endpoint (time frame: at Visit 2 (follow-up visit after 3 months of intervention period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.